This document summarizes information presented at the 2018 Conference on Retroviruses and Opportunistic Infections (CROI) regarding pre-exposure prophylaxis (PrEP) use and HIV prevention. Key points include:
- PrEP use has increased HIV prevention efforts but more is needed to reach global prevention targets. Studies showed declines in new HIV diagnoses associated with PrEP scale-up in San Francisco, Australia, and Montreal.
- Uptake of PrEP remains low among populations most at risk like Black and Hispanic men who have sex with men. Estimates found only 1% of Black individuals and 3% of Hispanic individuals with PrEP indications were prescribed PrEP.
- Barriers to
The document provides an overview of HIV/AIDS in India, focusing on what is known and what further data is needed for evidence-based decision making. It discusses HIV prevalence and risk factors in southern and northeastern states. While some data exists on high-risk groups like female sex workers, men who have sex with men, and injecting drug users, more systematic data collection is needed to better understand trends over time and inform targeted prevention programs. A rights-based, evidence-informed approach is critical to effectively address HIV in India.
Dr. Kathleen Brady of Philadelphia's AIDS Activities Coordinating Office (AACO) gave this presentation at the January 9, 2013 Comprehensive Planning Committee meeting.
01 Setswe~Hiv Prevention Where Is The Evidence Of Interventions That WorkNicholas Jacobs
The document summarizes evidence for HIV prevention interventions that work. It discusses biomedical interventions like male circumcision, HAART, and PMTCT that have good evidence of effectiveness ranging from 60-98% based on randomized controlled trials. It also reviews behavioral interventions like HIV counseling and testing, the Stepping Stones program, and structural interventions like microfinance combined with gender training, finding some have promising evidence of effectiveness while evidence is limited or lacking for others.
Burden of HIV and Research Gaps Among Key Populations in Sub-Saharan AfricaHopkinsCFAR
Key populations including sex workers, men who have sex with men, and people who inject drugs experience disproportionately high HIV burdens in sub-Saharan Africa due to various biological, behavioral, and structural factors. HIV prevalence among female sex workers ranges from 10.9% in Eastern Europe to 36.9% in sub-Saharan Africa, where sex workers are 12 times more likely to be infected than other women. Men who have sex with men also experience high HIV prevalence, though data remains limited in sub-Saharan Africa. Combination prevention approaches including behavioral, biomedical, and structural interventions are needed to address the outsized impact of HIV on key populations.
This study evaluated the suitability of populations of sexually active women in Madibeng, North-West Province and Mbekweni, Western Cape, South Africa for microbicide trials by determining HIV prevalence and incidence.
The study found an HIV prevalence of 24% in Madibeng and 22% in Mbekweni. HIV incidence rates based on seroconversions over 12 months in the cohort studies were 6.0/100 person-years in Madibeng and 4.5/100 person-years in Mbekweni. Incidence rates estimated by cross-sectional BED testing were similar. Pregnancy incidence rates were also determined.
Nearly all participants expressed a willingness to participate
Core practices that are moving from a pilot state to implementation at scale: Many of the
barriers facing HIV programs are common across countries. PEPFAR’s ECTs (described below in
Sections 2.3.2 and 2.3.3) identified common issues affecting countries at various levels of
epidemic control and then developed a compendium of evidence-based solutions, approaches
and case-studies that highlight successful means of addressing common barriers. Additional
evidence-based approaches and case-studies will be incorporated into this living compendium
over time. As highlighted in this PEPFAR Solutions Platform, these practices can be rapidly
adapted and scaled to move countries forward.
Key considerations for all PEPFAR programs include:
• Bringing Interventions to Scale with Fidelity: Getting to HIV epidemic control is dependent on
several factors; not the least of which is the ability to rapidly scale successful interventions with
fidelity and demonstrated impact. However, the logistics of cost- effective programmatic scale
have proven challenging, with several implementation barriers. Implementation science
defines scalability as the capacity to expand or extend an intervention to account for a growth
factor that aims to fill a gap or address unmet need in a defined population group/geographic
area.
• Data and Information Technology: The enabling environment for data and information
technology is rapidly maturing across countries, creating space, opportunity, and needed
political will to harness the Data Revolution for epidemic control. OUs should consider
innovative ways to use data and information technology to improve efficiency and
sustainability in achieving epidemic control, beyond immediate PEPFAR indicator data
collection needs. As highlighted in the Data Revolution Innovation Toolkit, available on the
PEPFAR SharePoint, OUs are encouraged to explore, adapt, and scale these and other data
driven approaches to move country epidemic control forward.
The document provides an overview of HIV/AIDS in India, focusing on what is known and what further data is needed for evidence-based decision making. It discusses HIV prevalence and risk factors in southern and northeastern states. While some data exists on high-risk groups like female sex workers, men who have sex with men, and injecting drug users, more systematic data collection is needed to better understand trends over time and inform targeted prevention programs. A rights-based, evidence-informed approach is critical to effectively address HIV in India.
Dr. Kathleen Brady of Philadelphia's AIDS Activities Coordinating Office (AACO) gave this presentation at the January 9, 2013 Comprehensive Planning Committee meeting.
01 Setswe~Hiv Prevention Where Is The Evidence Of Interventions That WorkNicholas Jacobs
The document summarizes evidence for HIV prevention interventions that work. It discusses biomedical interventions like male circumcision, HAART, and PMTCT that have good evidence of effectiveness ranging from 60-98% based on randomized controlled trials. It also reviews behavioral interventions like HIV counseling and testing, the Stepping Stones program, and structural interventions like microfinance combined with gender training, finding some have promising evidence of effectiveness while evidence is limited or lacking for others.
Burden of HIV and Research Gaps Among Key Populations in Sub-Saharan AfricaHopkinsCFAR
Key populations including sex workers, men who have sex with men, and people who inject drugs experience disproportionately high HIV burdens in sub-Saharan Africa due to various biological, behavioral, and structural factors. HIV prevalence among female sex workers ranges from 10.9% in Eastern Europe to 36.9% in sub-Saharan Africa, where sex workers are 12 times more likely to be infected than other women. Men who have sex with men also experience high HIV prevalence, though data remains limited in sub-Saharan Africa. Combination prevention approaches including behavioral, biomedical, and structural interventions are needed to address the outsized impact of HIV on key populations.
This study evaluated the suitability of populations of sexually active women in Madibeng, North-West Province and Mbekweni, Western Cape, South Africa for microbicide trials by determining HIV prevalence and incidence.
The study found an HIV prevalence of 24% in Madibeng and 22% in Mbekweni. HIV incidence rates based on seroconversions over 12 months in the cohort studies were 6.0/100 person-years in Madibeng and 4.5/100 person-years in Mbekweni. Incidence rates estimated by cross-sectional BED testing were similar. Pregnancy incidence rates were also determined.
Nearly all participants expressed a willingness to participate
Core practices that are moving from a pilot state to implementation at scale: Many of the
barriers facing HIV programs are common across countries. PEPFAR’s ECTs (described below in
Sections 2.3.2 and 2.3.3) identified common issues affecting countries at various levels of
epidemic control and then developed a compendium of evidence-based solutions, approaches
and case-studies that highlight successful means of addressing common barriers. Additional
evidence-based approaches and case-studies will be incorporated into this living compendium
over time. As highlighted in this PEPFAR Solutions Platform, these practices can be rapidly
adapted and scaled to move countries forward.
Key considerations for all PEPFAR programs include:
• Bringing Interventions to Scale with Fidelity: Getting to HIV epidemic control is dependent on
several factors; not the least of which is the ability to rapidly scale successful interventions with
fidelity and demonstrated impact. However, the logistics of cost- effective programmatic scale
have proven challenging, with several implementation barriers. Implementation science
defines scalability as the capacity to expand or extend an intervention to account for a growth
factor that aims to fill a gap or address unmet need in a defined population group/geographic
area.
• Data and Information Technology: The enabling environment for data and information
technology is rapidly maturing across countries, creating space, opportunity, and needed
political will to harness the Data Revolution for epidemic control. OUs should consider
innovative ways to use data and information technology to improve efficiency and
sustainability in achieving epidemic control, beyond immediate PEPFAR indicator data
collection needs. As highlighted in the Data Revolution Innovation Toolkit, available on the
PEPFAR SharePoint, OUs are encouraged to explore, adapt, and scale these and other data
driven approaches to move country epidemic control forward.
1) The study evaluated the suitability of populations of sexually active women in two districts of South Africa, Madibeng and Mbekweni, for microbicide trials by determining HIV prevalence and incidence.
2) HIV prevalence was 24% in Madibeng and 22% in Mbekweni. Estimated HIV incidence rates were 6.0/100 person-years in Madibeng and 4.5/100 person-years in Mbekweni.
3) Pregnancy incidence rates were 4.8/100 person-years in Madibeng and 7.0/100 person-years in Mbekweni. Genital symptoms were very common.
4) The
This document summarizes key information from an HIV & Global Health Rounds presentation on updates from the 2020 Conference on Retroviruses and Opportunistic Infections (CROI 2020). The presentation covered the global HIV epidemic, contraception and prevention, treatment as prevention, pre-exposure prophylaxis (PrEP), and HIV vaccines. Highlights included findings from the ECHO contraceptive study showing no increased HIV risk from various contraceptives, modest reductions in HIV incidence from universal test and treat trials, long-term efficacy and safety data from the DISCOVER PrEP trial, and the failure of the HVTN 702 vaccine trial to show efficacy.
Achievements and Implications of HIV Prevention Programme among Female Sex wo...QUESTJOURNAL
Background: Plateau State, Nigeria with HIV prevalence rate of 7.7% as at 2010 had among the highest HIV and syphilis levels in Nigeria, earning itself a reputation of being one of the 12 + 1 states contributing the highest HIV prevalence in Nigeria and described as “hot zone” of HIV infections. Factors responsible for this were not unrelated to the high-risk activities of Female Sex Workers (FSWs). This paper therefore presents achievements and implications HIV prevention among FSWs in Plateau State, Nigeria Methods: This project was an intervention effort focused on delivering evidence-based HIV prevention activities among FSWs in 3 local government areas within the State. The estimated target population for the study was 460 and this project used the minimum prevention package intervention (MPPI). Peer educators were selected and trained among the FSWs to reach out to their peers using cohort session. Data were documented using various monitoring and evaluation tools, entered on the District Health Information Software version 2 and analyzed using Microsoft Excel. Results: A total of 68 community dialogues were held with 1,466 influencers participating in the process. In addition, 601 peers were registered, while 18 persons benefitted from 27 income generation activities aimed at capacity building for FSWs. A total of 642 persons were counseled, tested and shown their results, with 15 persons tested positive resulting in HIV prevalence of 2.3%. Although 10,560 condoms were distributed however, these numbers was below the number of condoms required during the intervention. Conclusion: This intervention was a success. However, more needs to be done with regards to condom distribution and supply among FSWs since there is a crucial role for FSWs to play in the plot of taking the HIV prevalence of Plateau State even further down
This document provides guidance on indicators for monitoring progress towards commitments in the 2016 UN Political Declaration on HIV/AIDS. It outlines 10 commitments to end the AIDS epidemic by 2030, including ensuring 30 million people on treatment and eliminating new HIV infections in children. Over 50 indicators are presented to measure outcomes such as HIV prevalence, treatment coverage, condom use, and expenditures. The guidance is intended to help countries report annually on progress implementing their national HIV responses.
Stephen Rawlings, MD, PhD
Clinical Fellow
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
At baseline, two of 986 sex workers were HIV positive in Madagascar. 77.5% of sex workers in Antananarivo and 73.5% in Tamatave had at least one curable sexually transmitted infection (STI). Two months after treatment and counseling, 64.9% of sex workers in Antananarivo and 57.4% in Tamatave had at least one STI. The researchers developed evidence-based STI treatment guidelines for sex workers in Madagascar in collaboration with sex workers and health professionals. The guidelines included speculum exams, syphilis screening and treatment, and presumptive treatment for other STIs during initial and follow-up visits.
The UC San Diego AntiViral Research Center sponsors weekly presentations on infectious diseases research and clinical practices. A presentation on whether widespread HIV treatment can end transmission discussed recent trends showing HIV declining among adolescents and young adults in the US. The presentation reviewed research showing that early HIV treatment dramatically reduces heterosexual transmission but some transmission may still occur through anal sex among men who have sex with men on antiretroviral therapy. Future interventions could focus on optimizing HIV treatment, comparing antiretroviral regimens, and suppressing coinfections like CMV to further reduce HIV transmission.
This document summarizes national HIV prevention and care outcomes in the United States. Key metrics monitored include linkage to care after HIV diagnosis, retention in care, and viral suppression. Data on these indicators are collected through the National HIV Surveillance System and used to measure progress towards national goals. The document provides data on these indicators stratified by factors such as age, gender, race/ethnicity, and transmission category. It also discusses calculation methods and presents graphs illustrating trends in various indicators over time and across populations.
Maile Young Karris, MD
Associate Professor
Co-Director San Diego Center for AIDS Research Clinical Investigations Core
Divisions of Infectious Diseases & Global Public Health and Geriatrics & Gerontology
Department of Medicine
University of California San Diego
This document provides information from the HIV and AIDS Data Hub for Asia-Pacific on data availability and population size estimates of people who inject drugs, men who have sex with men, transgender people, and male sex workers across several countries in Asia and the Pacific region. It includes tables and charts with the countries where data is available from sentinel surveillance surveys, behavioral surveys, and population size estimates. It also provides references for the estimates and surveys.
The document summarizes HIV epidemiology among men who have sex with men (MSM) globally and in Asia Pacific. Some key points:
- HIV prevalence among MSM ranges from under 1% to over 25% depending on the country/region, with most of Asia and Africa over 5%.
- HIV is increasing among MSM in many countries as prevalence declines elsewhere, with urban areas often having much higher rates.
- Condom use and HIV testing is low among MSM in most areas. Criminalization and stigma also limit data collection and access to services.
- MSM population size estimates vary widely but are often in the hundreds of thousands to millions in Asia Pacific countries.
This document provides an organizational chart and descriptions of the STD/HIV surveillance program in Louisiana. It shows the data management and analysis units for STD and HIV data housed in different systems. It also lists contacts for HIV surveillance data and describes how prevention and counseling data are managed. Quick definitions of epidemiological terms and examples of rates and counts are provided.
Contemporary Management of HIV. New Data From AIDS 2018hivlifeinfo
This document summarizes key findings from the AIDS 2018 conference regarding contemporary management of HIV. It describes studies showing:
1) No linked HIV transmissions occurred in over 77,000 condomless sex acts when the HIV+ partner had an undetectable viral load in the PARTNER2 study.
2) On-demand PrEP was highly effective at preventing HIV in several studies when adherence was high.
3) Early results from the ANRS Prevenir study found no difference in HIV incidence between daily and on-demand PrEP, with high adherence in both groups.
This survey of 948 oncologists from 82 countries investigated which cancer medicines they deemed most essential for public health in their countries. The most commonly selected medicines were doxorubicin, cisplatin, paclitaxel, pembrolizumab, trastuzumab, carboplatin, and 5-fluorouracil - 19 of the top 20 medicines are currently on the WHO Essential Medicines List. Availability of these medicines was lowest in low-income countries, ranging from 9-54% availability, compared to 68-94% availability in high-income countries. Risk of catastrophic health expenditures for cancer treatment was also higher in low-income countries. The findings challenge the feasibility of adding more expensive
The document provides information on global AIDS response progress reporting for 2016. It outlines the reporting timeline, including the release of guidelines in February, use of the reporting tool in March, and a submission deadline of March 31st. It also summarizes changes to indicators for 2016, including new indicators on HIV status, prevalence, and care coverage, as well as indicators that will not be collected this year. Countries are advised to submit their data through the online reporting tool by the deadline in accordance with UNAIDS' mandate.
This document summarizes a study that assessed the prevalence of asymptomatic genital tract infections (GTIs) among sexually active youth in South Africa. The study found:
1) Over two-thirds of young women tested positive for at least one GTI, compared to just 10% of young men, with the majority of infections being asymptomatic.
2) Syndromic management identified a small fraction of actual GTI cases and was suboptimal for screening this population.
3) Youths' high burden of asymptomatic GTIs and other vulnerabilities increase their risk for HIV, highlighting the need for improved laboratory-based GTI screening and youth-centered HIV prevention programs.
Случаи и разногласия по ВИЧ в 2019 году: европейские перспективы / Cases and...hivlifeinfo
Learn unique perspectives across Europe on PrEP, rapid ART initiation, ART in women, and options for switching ART.
Format: Microsoft PowerPoint (.ppt)
File Size: 1.33 MB
Released: July 10, 2019
HIV/AIDS data Hub Asia Pacific -Malaysia 2014Dr. Rubz
This document provides a summary of HIV/AIDS data for Malaysia across multiple indicators:
- HIV prevalence is highest among key populations like people who inject drugs, female sex workers, and men who have sex with men. Condom use and safe injection practices have increased over time but remain below optimal levels.
- The number of reported HIV infections and AIDS-related deaths has declined in recent years. Most HIV transmissions are through heterosexual contact and injecting drug use.
- Vulnerability remains high as many key populations lack comprehensive HIV knowledge and access to prevention programs, testing, and treatment.
- Government spending on HIV has increased but more funding needs to be directed towards programs for key populations at higher
Leandro Mena, MD, MPH
Chair and Professor of Population Health Science
Department of Population Health Science
University of Mississippi Medical Center
Dr. Kathleen Brady of Philadelphia's AIDS Activities Coordinating Office (AACO) gave this presentation at the January 9, 2013 Comprehensive Planning Committee meeting.
1) The study evaluated the suitability of populations of sexually active women in two districts of South Africa, Madibeng and Mbekweni, for microbicide trials by determining HIV prevalence and incidence.
2) HIV prevalence was 24% in Madibeng and 22% in Mbekweni. Estimated HIV incidence rates were 6.0/100 person-years in Madibeng and 4.5/100 person-years in Mbekweni.
3) Pregnancy incidence rates were 4.8/100 person-years in Madibeng and 7.0/100 person-years in Mbekweni. Genital symptoms were very common.
4) The
This document summarizes key information from an HIV & Global Health Rounds presentation on updates from the 2020 Conference on Retroviruses and Opportunistic Infections (CROI 2020). The presentation covered the global HIV epidemic, contraception and prevention, treatment as prevention, pre-exposure prophylaxis (PrEP), and HIV vaccines. Highlights included findings from the ECHO contraceptive study showing no increased HIV risk from various contraceptives, modest reductions in HIV incidence from universal test and treat trials, long-term efficacy and safety data from the DISCOVER PrEP trial, and the failure of the HVTN 702 vaccine trial to show efficacy.
Achievements and Implications of HIV Prevention Programme among Female Sex wo...QUESTJOURNAL
Background: Plateau State, Nigeria with HIV prevalence rate of 7.7% as at 2010 had among the highest HIV and syphilis levels in Nigeria, earning itself a reputation of being one of the 12 + 1 states contributing the highest HIV prevalence in Nigeria and described as “hot zone” of HIV infections. Factors responsible for this were not unrelated to the high-risk activities of Female Sex Workers (FSWs). This paper therefore presents achievements and implications HIV prevention among FSWs in Plateau State, Nigeria Methods: This project was an intervention effort focused on delivering evidence-based HIV prevention activities among FSWs in 3 local government areas within the State. The estimated target population for the study was 460 and this project used the minimum prevention package intervention (MPPI). Peer educators were selected and trained among the FSWs to reach out to their peers using cohort session. Data were documented using various monitoring and evaluation tools, entered on the District Health Information Software version 2 and analyzed using Microsoft Excel. Results: A total of 68 community dialogues were held with 1,466 influencers participating in the process. In addition, 601 peers were registered, while 18 persons benefitted from 27 income generation activities aimed at capacity building for FSWs. A total of 642 persons were counseled, tested and shown their results, with 15 persons tested positive resulting in HIV prevalence of 2.3%. Although 10,560 condoms were distributed however, these numbers was below the number of condoms required during the intervention. Conclusion: This intervention was a success. However, more needs to be done with regards to condom distribution and supply among FSWs since there is a crucial role for FSWs to play in the plot of taking the HIV prevalence of Plateau State even further down
This document provides guidance on indicators for monitoring progress towards commitments in the 2016 UN Political Declaration on HIV/AIDS. It outlines 10 commitments to end the AIDS epidemic by 2030, including ensuring 30 million people on treatment and eliminating new HIV infections in children. Over 50 indicators are presented to measure outcomes such as HIV prevalence, treatment coverage, condom use, and expenditures. The guidance is intended to help countries report annually on progress implementing their national HIV responses.
Stephen Rawlings, MD, PhD
Clinical Fellow
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
At baseline, two of 986 sex workers were HIV positive in Madagascar. 77.5% of sex workers in Antananarivo and 73.5% in Tamatave had at least one curable sexually transmitted infection (STI). Two months after treatment and counseling, 64.9% of sex workers in Antananarivo and 57.4% in Tamatave had at least one STI. The researchers developed evidence-based STI treatment guidelines for sex workers in Madagascar in collaboration with sex workers and health professionals. The guidelines included speculum exams, syphilis screening and treatment, and presumptive treatment for other STIs during initial and follow-up visits.
The UC San Diego AntiViral Research Center sponsors weekly presentations on infectious diseases research and clinical practices. A presentation on whether widespread HIV treatment can end transmission discussed recent trends showing HIV declining among adolescents and young adults in the US. The presentation reviewed research showing that early HIV treatment dramatically reduces heterosexual transmission but some transmission may still occur through anal sex among men who have sex with men on antiretroviral therapy. Future interventions could focus on optimizing HIV treatment, comparing antiretroviral regimens, and suppressing coinfections like CMV to further reduce HIV transmission.
This document summarizes national HIV prevention and care outcomes in the United States. Key metrics monitored include linkage to care after HIV diagnosis, retention in care, and viral suppression. Data on these indicators are collected through the National HIV Surveillance System and used to measure progress towards national goals. The document provides data on these indicators stratified by factors such as age, gender, race/ethnicity, and transmission category. It also discusses calculation methods and presents graphs illustrating trends in various indicators over time and across populations.
Maile Young Karris, MD
Associate Professor
Co-Director San Diego Center for AIDS Research Clinical Investigations Core
Divisions of Infectious Diseases & Global Public Health and Geriatrics & Gerontology
Department of Medicine
University of California San Diego
This document provides information from the HIV and AIDS Data Hub for Asia-Pacific on data availability and population size estimates of people who inject drugs, men who have sex with men, transgender people, and male sex workers across several countries in Asia and the Pacific region. It includes tables and charts with the countries where data is available from sentinel surveillance surveys, behavioral surveys, and population size estimates. It also provides references for the estimates and surveys.
The document summarizes HIV epidemiology among men who have sex with men (MSM) globally and in Asia Pacific. Some key points:
- HIV prevalence among MSM ranges from under 1% to over 25% depending on the country/region, with most of Asia and Africa over 5%.
- HIV is increasing among MSM in many countries as prevalence declines elsewhere, with urban areas often having much higher rates.
- Condom use and HIV testing is low among MSM in most areas. Criminalization and stigma also limit data collection and access to services.
- MSM population size estimates vary widely but are often in the hundreds of thousands to millions in Asia Pacific countries.
This document provides an organizational chart and descriptions of the STD/HIV surveillance program in Louisiana. It shows the data management and analysis units for STD and HIV data housed in different systems. It also lists contacts for HIV surveillance data and describes how prevention and counseling data are managed. Quick definitions of epidemiological terms and examples of rates and counts are provided.
Contemporary Management of HIV. New Data From AIDS 2018hivlifeinfo
This document summarizes key findings from the AIDS 2018 conference regarding contemporary management of HIV. It describes studies showing:
1) No linked HIV transmissions occurred in over 77,000 condomless sex acts when the HIV+ partner had an undetectable viral load in the PARTNER2 study.
2) On-demand PrEP was highly effective at preventing HIV in several studies when adherence was high.
3) Early results from the ANRS Prevenir study found no difference in HIV incidence between daily and on-demand PrEP, with high adherence in both groups.
This survey of 948 oncologists from 82 countries investigated which cancer medicines they deemed most essential for public health in their countries. The most commonly selected medicines were doxorubicin, cisplatin, paclitaxel, pembrolizumab, trastuzumab, carboplatin, and 5-fluorouracil - 19 of the top 20 medicines are currently on the WHO Essential Medicines List. Availability of these medicines was lowest in low-income countries, ranging from 9-54% availability, compared to 68-94% availability in high-income countries. Risk of catastrophic health expenditures for cancer treatment was also higher in low-income countries. The findings challenge the feasibility of adding more expensive
The document provides information on global AIDS response progress reporting for 2016. It outlines the reporting timeline, including the release of guidelines in February, use of the reporting tool in March, and a submission deadline of March 31st. It also summarizes changes to indicators for 2016, including new indicators on HIV status, prevalence, and care coverage, as well as indicators that will not be collected this year. Countries are advised to submit their data through the online reporting tool by the deadline in accordance with UNAIDS' mandate.
This document summarizes a study that assessed the prevalence of asymptomatic genital tract infections (GTIs) among sexually active youth in South Africa. The study found:
1) Over two-thirds of young women tested positive for at least one GTI, compared to just 10% of young men, with the majority of infections being asymptomatic.
2) Syndromic management identified a small fraction of actual GTI cases and was suboptimal for screening this population.
3) Youths' high burden of asymptomatic GTIs and other vulnerabilities increase their risk for HIV, highlighting the need for improved laboratory-based GTI screening and youth-centered HIV prevention programs.
Случаи и разногласия по ВИЧ в 2019 году: европейские перспективы / Cases and...hivlifeinfo
Learn unique perspectives across Europe on PrEP, rapid ART initiation, ART in women, and options for switching ART.
Format: Microsoft PowerPoint (.ppt)
File Size: 1.33 MB
Released: July 10, 2019
HIV/AIDS data Hub Asia Pacific -Malaysia 2014Dr. Rubz
This document provides a summary of HIV/AIDS data for Malaysia across multiple indicators:
- HIV prevalence is highest among key populations like people who inject drugs, female sex workers, and men who have sex with men. Condom use and safe injection practices have increased over time but remain below optimal levels.
- The number of reported HIV infections and AIDS-related deaths has declined in recent years. Most HIV transmissions are through heterosexual contact and injecting drug use.
- Vulnerability remains high as many key populations lack comprehensive HIV knowledge and access to prevention programs, testing, and treatment.
- Government spending on HIV has increased but more funding needs to be directed towards programs for key populations at higher
Leandro Mena, MD, MPH
Chair and Professor of Population Health Science
Department of Population Health Science
University of Mississippi Medical Center
Dr. Kathleen Brady of Philadelphia's AIDS Activities Coordinating Office (AACO) gave this presentation at the January 9, 2013 Comprehensive Planning Committee meeting.
Adherencia al tarv en am latina y caribeRosa Alcayaga
This systematic review and meta-analysis examined adherence to antiretroviral therapy (ART) among people living with HIV in Latin America and the Caribbean. The analysis included 53 studies published between 2005-2016 involving over 22,000 individuals across 25 countries. The overall adherence rate was estimated to be 70%, similar to rates in high-income regions. Adherence was higher with shorter recall periods and in lower income countries. Common barriers to adherence included substance abuse, depression, unemployment and pill burden. The review suggests adherence in the region may be below the level needed for long-term viral suppression.
Rawlings Provider Specialty and Payer Trends HIVTW and R4P 2016 posterKeith Rawlings
This document analyzes trends in pre-exposure prophylaxis (PrEP) utilization from 2012-2015 using national electronic patient data from pharmacies. It finds that 79,684 individuals received PrEP, with family medicine, internal medicine, infectious diseases, and emergency medicine accounting for 84% of prescriptions. For males, family medicine and internal medicine were the primary prescribers, while for females it was emergency medicine and family planning. Starts for males were most commonly covered by commercial insurance and Medicaid, while females were mostly covered by Medicaid. The results indicate gender differences in PrEP prescribers and insurance coverage that have implications for linking patients to prevention services differently for men and women.
This document summarizes key information about HIV in the United States:
- Over 1.1 million people are living with HIV in the US, with about 56,000 new infections each year. Rates are highest among men who have sex with men, African Americans, Latinos, and intravenous drug users.
- Effective prevention strategies include promoting abstinence, fewer partners, condom use, not sharing needles, antiretroviral treatment, male circumcision, and pre-exposure prophylaxis. Widespread testing is also an important prevention approach.
- Combining multiple prevention approaches and targeting high-risk groups can maximize the impact of HIV prevention and reduce transmission rates in the US.
Lessons learned from Brazil on HIV self-testing and pre-exposure prophylaxisCheryl Johnson
(1) Brazil has an estimated 781,000 people living with HIV/AIDS, with prevalence rates highest among key populations like men who have sex with men and transgender women. (2) Several PrEP studies have been conducted in Brazil to evaluate its effectiveness and uptake among high-risk groups. (3) The Brazilian Ministry of Health plans to make PrEP available for free nationwide by the end of 2016 as part of its efforts to control the HIV epidemic through combination prevention approaches tailored for priority populations.
Getting to scale: How we can achieve the reach required of prevention service...HopkinsCFAR
This document discusses disparities in HIV/STI rates among Black and White MSM in Atlanta from 2009-2014. The study found significantly higher rates of new HIV infections, prevalent HIV infections, and STIs among Black MSM compared to White MSM. Factors contributing to the disparities included higher community-level HIV prevalence among Black MSM networks, increased likelihood of Black MSM encountering an HIV-positive partner, geographic clustering of Black MSM in high-poverty/high-stigma neighborhoods, and higher rates of condom failures or incomplete use among Black MSM. The document advocates for scaling up multiple prevention interventions like PrEP to achieve sufficient coverage levels to meaningfully reduce new HIV transmissions.
The document summarizes HIV engagement in care data for Philadelphia and nationally. It finds that in Philadelphia in 2009, 82% of people living with HIV were aware of their infection, 62% were linked to care, 52% were retained in care, 46% were prescribed antiretroviral therapy (ART), and 30% had viral suppression. Nationally, the rates were slightly higher. The epidemic in Philadelphia primarily affects minorities and transmission is mostly through men who have sex with men and heterosexual contact. While new AIDS cases have declined 25%, growing numbers are living with HIV. Around 20-30% have unmet needs and are not engaged in regular HIV care.
This document provides an overview of the HIV/AIDS epidemic and programmatic response in Uttar Pradesh, India. It finds that key vulnerability factors driving the epidemic include a large population, gender disparities, the presence of high-risk groups like migrants, female sex workers, and injecting drug users. HIV prevalence trends show a concentrated epidemic among high-risk groups but signs of spread to the general population. The government's response under NACP III aims to prevent new infections, increase access to care and treatment, build capacity, and strengthen strategic information systems through targeted interventions for high-risk groups and the general population. Key ongoing challenges include curbing the spread from high-risk to low-risk groups and further decentralizing
This document discusses gender dimensions of HIV/AIDS among young girls in the context of achieving the Millennium Development Goals. It provides background on MDG 6, which aims to combat HIV/AIDS, malaria, and other diseases. It notes that young women ages 15-24 are particularly vulnerable to HIV infection due to various biological and socioeconomic factors. Statistics about HIV prevalence, condom use, and access to treatment in Bangladesh are presented. The document also discusses programs and interventions supported by various organizations to prevent HIV and achieve universal access to treatment.
This document summarizes the status and management of HIV/AIDS in India. It finds that India has an estimated 2.4 million people living with HIV, with high prevalence states accounting for over half of infections. The epidemic is concentrated among high-risk groups and spread primarily through unprotected sex and injection drug use. The national response involves targeted interventions for high-risk groups, STI management, condom promotion, blood safety programs, counseling/testing, and care/treatment. While prevalence is declining overall, some low prevalence states are seeing rises, emphasizing the need to sustain prevention efforts.
This document summarizes the status of the HIV/AIDS epidemic in India. Some key points:
- India has an estimated 2.4 million people living with HIV, with prevalence highest in the southern and northeastern states.
- The epidemic is concentrated among high-risk groups like sex workers, clients of sex workers, men who have sex with men, and injection drug users.
- Unsafe sex, lack of condom use, and injection drug use fuel transmission. Migration and the low status of women also increase vulnerability.
- The national response involves targeted interventions for high-risk groups, care/treatment, and prevention education through NACP programs.
Jill Blumenthal, MD
Assistant Professor of Medicine
Division of Infectious Diseases and Global Public Health
Department of Medicine
University of California, San Diego
Dr. Kathleen Brady (AACO)'s annual epidemiological update. This presentation was given to the Philadelphia EMA Ryan White Planning Council on Thursday, February 20, 2014.
Comparing local epidemiology of Chlamydia in Miami- Dade County to that of State of Florida and the United States. Highlighting basic description of the disease, surveillance methods, reporting, control measures, epidemiology of the disease and comparison of 5 year trends/incident rates in Miami Dade County to that of State of Florida and the United States.
Dr. William R. Short presented this review of PrEP research from the Conference on Retroviruses and Opportunistic Infections to the PrEP Workgroup of the HIPC's Prevention Committee in April 2018.
This document reports on increases in hepatitis A virus (HAV) infections in the United States from 2013-2018. HAV infections reported to the CDC increased 294% during 2016-2018 compared to 2013-2015, related to outbreaks among people who use drugs or experience homelessness. Additionally, increases occurred among men who have sex with men and from imported contaminated foods. Genotype IB was the most common strain identified during 2016-2018. Increased vaccination of at-risk groups, including people who use drugs or experience homelessness, could help control ongoing outbreaks and prevent future increases in HAV infections.
Global Medical Cures™ | HIV TESTING IN USA
DISCLAIMER-
Global Medical Cures™ does not offer any medical advice, diagnosis, treatment or recommendations. Only your healthcare provider/physician can offer you information and recommendations for you to decide about your healthcare choices.
Fast-track the end of AIDS in the EU - practical evidence-based interventions.
Presentation by: Jean-Michel Molina, Assistance Publique Hôpitaux de Paris
In a two-day meeting under the auspices of the Maltese Presidency of the Council of the European Union (30-31 January 2017), HIV experts from across the European Union discussed how to reverse this trend and how to prepare Europe to achieve the set target of ending AIDS by 2030.
Public Health HIV/STD Control in the US in the Era of TASP: 90-90-90 and Beyond
Matthew Golden, MD, MPH
February 2nd, 2018
UCSD HIV & Global Health Rounds
Katherine Promer Flores, MD (she/her)
Staff Physician
Division of Infectious Diseases and Global Public Health
Department of Medicine
University of California San Diego
Daniel Lee, MD
Clinical Professor of Medicine
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
Edward Cachay, MD, MAS
Professor of Medicine
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
Gabriel Wagner, MD
Associate Clinical Professor
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
Jocelyn Keehner, MD
Infectious Disease Fellow
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
This presentation summarizes research on cryptococcal antigen screening and treatment in resource-limited settings. It finds that screening individuals with CD4 counts <100 cells/uL and <200 cells/uL can reduce mortality, and point-of-care tests now enable screening in primary care clinics. Studies of simplified treatment regimens show promise, such as using high-dose liposomal amphotericin B for only 1-2 weeks. Field work in Mozambique demonstrated a 7.3% prevalence of cryptococcal antigenemia through screening at two clinics, and identified opportunities to improve care through expanded screening and ambulatory treatment models.
Richard Garfein, PhD, MPH
Professor
Herbert Wertheim School of Public Health and Human Longevity Science
Adjunct Professor
Division of Infectious Disease and Global Public Health
Department of Medicine
University of California, San Diego
Este documento fornece informações sobre uma sessão de treinamento virtual sobre HIV/AIDS para militares internacionais. A agenda inclui atualizações sobre a vacina COVID-19 e sua implementação na Nigéria, com discussões sobre implicações para pessoas vivendo com HIV. A sessão é conduzida pelo programa MIHTP-ECHO com o objetivo de melhorar o atendimento e prevenção de HIV em militares em todo o mundo.
This document provides information about a MIHTP-ECHO training session on COVID-19 vaccines. It includes the agenda, presenters, and an overview of MIHTP and the ECHO model. The presentation by Dr. Allen McCutchan will discuss COVID epidemiology, vaccine mechanisms of action, effectiveness, safety, and duration of protection. It will also cover implications for people living with HIV and emerging variants. A presentation by Captain UO Adekanye will provide an update on Nigeria's COVID vaccine rollout and implications for people living with HIV. The session aims to inform participants and facilitate discussion on these topics.
Laura Bamford, MD, MSCE
Associate Professor of Medicine
Medical Director, Owen Clinic
Division of Infectious Diseases and Global Public Health
Department of Medicine
University of California, San Diego
Davey Smith, MD, MAS
Professor of Medicine
Chief, Division of Infectious Diseases and Global Public Health
Co-Director, San Diego Center for AIDS Research (CFAR)
Department of Medicine
University of California, San Diego
Elliot Welford, MD
Infectious Diseases Fellow
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
Darcy Wooten, MD
Assistant Professor of Medicine
Associate Program Director, Infectious Diseases Fellowship
Division of Infectious Diseases & Global Public Health
Department of Medicine
University of California, San Diego
This document summarizes a presentation on new and investigational antiretrovirals given at the UC San Diego HIV & Global Health Rounds. The presentation reviewed fostemsavir, cabotegravir/rilpivirine, leronlimab, islatravir, and lenacapavir. For each drug, the presenter discussed indications, dosing, efficacy and safety data from clinical trials, resistance profiles, and potential advantages and limitations. The goal of the HIV & Global Health Rounds is to provide clinicians and researchers with the most up-to-date information on HIV, hepatitis, tuberculosis, and other infectious diseases.
This document summarizes a presentation on hepatitis C virus (HCV) epidemiology and screening recommendations. It discusses global and local HCV prevalence, the health impacts and economic costs of HCV infection, and the potential for HCV elimination with new direct-acting antiviral treatments. It also reviews evolving HCV screening guidelines and epidemiologic trends in the US, including increasing infections associated with opioid epidemics. Risk factors for HCV transmission are identified based on a study of HCV-positive blood donors.
Winston Tilghman, MD
Medical Director, STD Controller
HIV, STD & Hepatitis Branch of Public Health Services
County of San Diego Health & Human Services Agency
Scott Letendre, MD
Professor in Residence
Division of Infectious Diseases & Global Public Health
Departments of Medicine and Psychiatry
University of California, San Diego
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Osvaldo Bernardo Muchanga-GASTROINTESTINAL INFECTIONS AND GASTRITIS-2024.pdfOsvaldo Bernardo Muchanga
GASTROINTESTINAL INFECTIONS AND GASTRITIS
Osvaldo Bernardo Muchanga
Gastrointestinal Infections
GASTROINTESTINAL INFECTIONS result from the ingestion of pathogens that cause infections at the level of this tract, generally being transmitted by food, water and hands contaminated by microorganisms such as E. coli, Salmonella, Shigella, Vibrio cholerae, Campylobacter, Staphylococcus, Rotavirus among others that are generally contained in feces, thus configuring a FECAL-ORAL type of transmission.
Among the factors that lead to the occurrence of gastrointestinal infections are the hygienic and sanitary deficiencies that characterize our markets and other places where raw or cooked food is sold, poor environmental sanitation in communities, deficiencies in water treatment (or in the process of its plumbing), risky hygienic-sanitary habits (not washing hands after major and/or minor needs), among others.
These are generally consequences (signs and symptoms) resulting from gastrointestinal infections: diarrhea, vomiting, fever and malaise, among others.
The treatment consists of replacing lost liquids and electrolytes (drinking drinking water and other recommended liquids, including consumption of juicy fruits such as papayas, apples, pears, among others that contain water in their composition).
To prevent this, it is necessary to promote health education, improve the hygienic-sanitary conditions of markets and communities in general as a way of promoting, preserving and prolonging PUBLIC HEALTH.
Gastritis and Gastric Health
Gastric Health is one of the most relevant concerns in human health, with gastrointestinal infections being among the main illnesses that affect humans.
Among gastric problems, we have GASTRITIS AND GASTRIC ULCERS as the main public health problems. Gastritis and gastric ulcers normally result from inflammation and corrosion of the walls of the stomach (gastric mucosa) and are generally associated (caused) by the bacterium Helicobacter pylor, which, according to the literature, this bacterium settles on these walls (of the stomach) and starts to release urease that ends up altering the normal pH of the stomach (acid), which leads to inflammation and corrosion of the mucous membranes and consequent gastritis or ulcers, respectively.
In addition to bacterial infections, gastritis and gastric ulcers are associated with several factors, with emphasis on prolonged fasting, chemical substances including drugs, alcohol, foods with strong seasonings including chilli, which ends up causing inflammation of the stomach walls and/or corrosion. of the same, resulting in the appearance of wounds and consequent gastritis or ulcers, respectively.
Among patients with gastritis and/or ulcers, one of the dilemmas is associated with the foods to consume in order to minimize the sensation of pain and discomfort.
The biomechanics of running involves the study of the mechanical principles underlying running movements. It includes the analysis of the running gait cycle, which consists of the stance phase (foot contact to push-off) and the swing phase (foot lift-off to next contact). Key aspects include kinematics (joint angles and movements, stride length and frequency) and kinetics (forces involved in running, including ground reaction and muscle forces). Understanding these factors helps in improving running performance, optimizing technique, and preventing injuries.
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
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Visit Us: https://drdeepikashomeopathy.com/service/irregular-periods-treatment/
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The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
2. PrEP in 2018 and Beyond
Trevor Hawkins MD
Senior Director, Medical Affairs,
Gilead Sciences, Foster City, CA
3. ‡
2
HIV Prevention: The Big Picture
Prevention Gap Report (UNAIDS, 2016): Efforts to reach fewer than
500,000 new HIV infections by 2020 are off track
Huge successes in treatment uptake-19 million on ART.
Decline of new HIV infections is substantially slower than the fall in
AIDS-related deaths, and epidemic control remains out of reach
Accelerated decline in new HIV infections is required to avoid a
rebound of the epidemic, especially among key populations. It is
possible that we could lose control of the epidemic, especially in young
people.
Gilead confidential and proprietary-for internal use only
4. ‡
3
If we use the Tools
3
UNAIDS, 2015 estimates from the AIDSinfo online database. Gilead Sciences Confidential - For Advisory Purposes Only
5. ‡
4
Between 2008-2014, incident HIV infections fell from 45,700 to 37,600
Heterosexuals
8,600 infections
(36% decline since 2008)
CDC: HIV Incidence Down 18% in US Between 2008-2014
CDC National HIV Surveillance System Data
Though HIV incidence has declined in the population as a whole in the US,
HIV in MSM remained stable and increased in some subpopulations.
Southern states comprised 50% of all new HIV infections in 2014.
‡
People who inject drugs
1,700 infections
(56% decline since 2008)
Gay and bisexual men
who inject drugs
1,100 infections
Gay and bisexual men
26,200 infections
(Stable since 2008)
• Proportion of MSM estimated to be living
with HIV but not yet diagnosed:
o Black 20.4%; Latino 20.9%; White 12.5%
• Incident HIV infections:
o Remained stable in Black MSM
o Increased 20% in Latino MSM
o Decreased 18% in White MSM
39,393 New HIV Infections in 2015a
New HIV infections decreased in many
MSM, but rose in MSM aged 25-34.
13-24 25-34 35-44 45-54 ≥55
23%
70%
Gilead confidential and proprietary-for internal use only
a. Data has been statistically adjusted to account for missing transmission category.
6. New Zealand
Nigeria
Norway
Peru
South Africa
Swaziland*
South Korea
Taiwan
Truvada approved for prevention1
Regulatory Status of Truvada for PrEP
Updated Feb 2018
Regulatory application submitted for a
prevention indication for Truvada2
Equador
Australia
Brazil
Canada
Chile
France (RTU)
Hong Kong
Israel
Kenya
Lesotho*
Malawi
Tanzania
Thailand
Uganda
United States
Zambia
Zimbabwe
*Approved via import license from South Africa.
• The European Commission granted Gilead
marketing authorization for Truvada as PrEP in Q3
2016. This should encourage countries within the
EU to make PrEP available within their national
health systems, based on cost factors and
individual country regulatory requirements. Gilead Confidential
7. Gilead Confidential and Proprietary—for Internal Use Only
‡
National - Truvada for PrEP Trends for December 2017
Individuals Taking TVD for PrEP (Active) (K) Individuals Initiating Truvada for PrEP
Dec 2017: 8,320
YTD 2017 Avg:
8,990
(+16% vs 2016)
Over 2017, active writers (3 PrEP/12 months) grew by 48% to 8.6K and total PrEP writers
(1 Rx/12 months) increased ~2 fold (19K to 38K)
6
8. The Potential Role of PrEP in Reducing New HIV Infection
7
Buchbinder S, et al. CROI 2018. Boston, MA. Oral #87.
Citywide initiative to increase PrEP uptake in high risk HIV-negative individuals as well as
increase rapid ART initiation and improve the care continuum in PLWHIV
PrEP use in San Francisco has been increasing over time. This effort, in combination with
improving the treatment cascade, is associated with a significant decrease in new HIV
infections.
Getting to Zero San Francisco
• Based on 2 surveys, 37-45% of HIV negative MSM on PrEP in last year.
9. Decreases in HIV Incidence Coincide with Expanded PrEP Use
8
Retrospective study from the research database of Clinique médicale l’Actuel,
2011-2016
Beauchemin M, et al. CROI 2018, Boston, MA. Poster #1037.
Efforts should be made to further increase accessibility of combined
prevention measures in semi-urban/rural areas in Quebec and among youth
and older populations, who may be less aware of the availability and
effectiveness of PrEP
Clinique médicale l’Actuel, Montreal, Quebec
10. ‡
9
Rapid Reduction in HIV Diagnoses After PrEP Implementation
Statewide pragmatic PrEP implementation study in high risk individuals looking at population
effect of rapid, targeted, high-coverage PrEP roll-out, (N=3700)
In NSW, 80% of HIV infections are in MSM and the rate has been stable
– N=3602 included in analysis of HIV incidence
– 74% (n=2754) retention on PrEP through 12 months
Grulich A, et al. CROI 2018. Boson, MA. Oral #88. 9
New South Wales, Australia
Primary Outcome 2: Populations Level
Change in NSW HIV diagnoses in MSM
Recent (Last 12 Months) Infections All HIV Diagnoses
Before (n) After (n)
Percentage decline
(95% CI)
Before (n) After (n)
Percentage decline
(95% CI)
149 102 32% (24-40%) 295 221 25% (20-30%)
Primary Outcome 1: Cohort Level
Change in Incidence Rate after intervention
Rates
Cohort Incidence Rate (n=2)* 0.5/1000 PY
Expected Rate 2/100 PY
*2 confirmed new HIV infections over 3,927 person-years: 1 was dispensed
but never commenced PrEP; 1 took no PrEP for months prior to infection
Targeted PrEP roll-out at scale led to a substantial decline in new
HIV infections at the statewide level.
11. ‡
10
About AIDSVu
Siegler AJ, et al, CROI 2018. Boston, MA. Poster #1022LB.
Partnership since 2010 between
Gilead Sciences & Emory
University’s Rollins School of Public
Health
Mission to make HIV data widely
available, easily accessible &
locally relevant to inform public
health decision making
Interactive online mapping tool to
visualize the U.S. HIV epidemic at
state-, county- & ZIP code-level
10
13. ‡
12
Priority Populations: Targeting Populations at Risk and
Geographic Areas of Greatest Need
Population by Race/Ethnicity
1) US Census American Fact Finder, 2015
2) CDC HIV Surveillance Report, 2014; November 2015
3) Bush S, et al. ASM 2016; based on 43.7% of unique FTC/TDF for PrEP starts 2012-Q3/2015
Focus on MSM of color, the South, women
(cis and transgender)
New Infections by
Race/Ethnicity
PrEP Uptake by
Race/Ethnicity
Top 10 MSA’s for HIV Incidence
1. Baton Rouge, LA
2. Miami, FL
3. New Orleans, LA
4. Jackson, MS
5. Orlando, FL
6. Memphis, TN
7. Atlanta, GA
8. Columbia, SC
9. Jacksonville, FL
10. Baltimore, MD
Men are 70% of PrEP Users
Gilead confidential and proprietary-for internal use only
14. Drug Utilization in the United States: Latest 12 Months
Five Areas: West Manhattan, Chicago North, San Francisco North, Boston and Seattle
account for 31% of total volume prescribed for Truvada for PrEP
Source: R12M Mar’16 – Feb’17 SHA PTD Claims Data.
Midwest 14.3% Southeast 14.6% Central 18.4% West 24.5% Northeast 28.3%
Houston-New
Orleans
3.4%
Washington
North
3.3%
Chicago
North
6.7%
San Francisco
North
6.2%
West
Manhattan
7.6%
Dallas 2.9%
Washington
South
3.1% Atlanta 4.0% Seattle 4.6% Boston 5.7%
Las Vegas-
Phoenix
2.4% Palm Beach 2.5%
Columbus-
Pittsburgh
2.7% Los Angeles 3.6% Midtown East 4.3%
Minneapolis 2.3%
Orlando-
Tampa
2.0%
Chicago
South
1.8% Torrance 2.7%
Upper
Midtown
3.9%
Austin 1.9%
Durham-
Charlotte
1.5%
Cleveland-
Detroit
1.8%
San Francisco
South
2.5% Philly-NJ 3.2%
Denver 1.3% Miami 1.4% Milwaukee 1.4% San Diego 2.1%
Upper
Manhattan
2.2%
Baltimore 0.7% Irvine 1.7% Brooklyn 1.4%
East Bay 1.3%
Confidential - For Internal Use Only
Regional Contribution of Truvada for PrEP
15. ‡
14
Estimated Number of Adults with PrEP Indications, US,
2015, Comparison of Results from Two Methods
1
CDC
MSM HET PWID Total*
Updated CDC
Estimate
814,000 258,000 73,000 1,145,000
Previous CDC
Estimate
492,000 624,000 115,000 1,232,000
Black and Hispanic* 65.1% 81.8% 57.1%
*Estimates are rounded and may not sum to the total.
Smith D, et al, CROI 2018. Boston, MA. Poster #86.
• # Black/Latino/PWID with PrEP indications =
• state % Black/Latino/PWID HIV dx of all MSM with HIV dx *
• # MSM/HET/PWID with PrEP indications
16. Gilead Confidential and Proprietary—for Internal Use Only
‡
Preliminary Estimate of Minimum PrEP Coverage by US
Region and Race/Ethnicity, 2015-2016
15
CDC
Denominator:
– Number of persons with
indications for PrEP, 2015
Numerator:
– Number of persons
prescribed TRUVADA for
PrEP, US
– Symphony Health
Analytics, September 2015-
August 2016
– Race/ethnicity available for
66%
29
3
2
1
2
0
5
10
15
20
25
30
35
Northeast Midwest South West
%PrEPCoverage
White Black Hispanic All race/ethnicities
Nationwide, 14% of White, 1% of Black, 3% of Hispanic, and 8% of all persons
estimated to have indications for PrEP were prescribed PrEP.
Smith D, et al, CROI 2018. Boston, MA. Poster #86.
17. Gilead Confidential and Proprietary—for Internal Use Only
‡
Individual and Network Drivers of Racial Disparities
Among YMSM-Longitudinal Cohort Study of YMSM (16-
29 Y/O) Living in Chicago (N=1015)
Compared to White and Latino
subjects, YBMSM had:
A higher prevalence of both HIV
(32%; p<0.001) and rectal STIs
(26.5%; p=0.011)
Lower rates of participation in
sexual risk practices (p<0.001)
Greater number of lifetime HIV
tests (p<0.001)
Less likely to achieve viral
suppression (p=0.01)
Greater racial homophily with
sexual partners (p<0.001)
Had stronger relationship ties
(p<0.001)
Greater levels of:
– Stigma (p<0.001)
– Victimization (p=0.04)
– Trauma (p<0.001)
– Childhood sexual abuse (ever)
(p<0.001)
Mustanski B et al. CROI 2018. Boston, MA. Poster #906. 16
.
18. Gilead Confidential and Proprietary—for Internal Use Only
‡
Black and Latino MSM
Stigma
– Medical mistrust
– Identity/socialization factors
– Recent healthcare experiences
Lack of cultural sensitivity
Slow uptake is intrinsically linked to larger issues around why Black
and Latino MSM have higher rates of HIV; higher rates of
incarceration, lower education, domestic and street violence, higher
unemployment and housing instability
Barriers to PrEP Engagement
Gilead confidential and proprietary-for internal use only
19. Gilead Confidential and Proprietary—for Internal Use Only
‡
Estimated New HIV Infections in the US, by Age, 2014
174 35
1,828
7,868 7,870
6,026
4,662
4,196
4,021
3,242
2,166
1,069 914
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
<13 13-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 >65
EstimatedNewHIVinfections,n
Centers for Disease Control and Prevention. HIV Surveillance Report, 2014; vol. 26. http://www.cdc.gov/hiv/library/reports/surveillance/. Published November 2015. Accessed April 13, 2016.
22%
17%
Persons <25 and >50 years old comprised almost 40% of new HIV infections in 2014.
Gilead confidential and proprietary-for internal use only
20. Gilead Confidential and Proprietary—for Internal Use Only
‡
24%
76%
11%
89%
83,672 Men15,060 Women
Age of FTC/TDF for PrEP Users in US
2012-2016
Mean age of 98,732 unique individuals: 37.3 years + 11.8
Average Age 37.7
2012 39.4
2016 37.1
<25 years
≥25 years
Average Age 35.0
2012 34.5
2016 36.7
21. Gilead Confidential and Proprietary—for Internal Use Only
‡
The Adolescent Brain is Different from the Adult Brain
Less developed frontal lobe capacities for executive function,
impulse control, long-term decision making
More developed limbic lobe favoring emotions, impulsive behavior
and short-term gratification
Information alone will not diminish risk-taking
Gilead confidential and proprietary-for internal use only
22. Gilead Confidential and Proprietary—for Internal Use Only
‡
Safety and Efficacy of FTC/TDF for PrEP in MSM Aged 15-
17 in the United States*
Open-label, multi-site US demonstration project of
Truvada for PrEP in 15-17yo MSM, n=79
ATN 113: PrEP Demonstration Project and Safety Study
• Sharp drop in adherence when transitioning
from monthly to quarterly follow-up
• 95% had detectable drug when monitoring was monthly
• Unlike ATN 110 (18-22yo), drop in adherence was
consistent across all races/ethnicities
• Compared with adherent participants, non-
adherent participants tended to be more likely
to endorse the beliefs:
• “I worry others will see me taking pills and think I am
HIV-positive” (p=.03)
• “I am concerned people will know I have sex with other
men because I’m taking PrEP” (p=.06)
• “I don’t like taking pills” (p=.06)
• 3 seroconversions occurred in 3
adolescents with no detectable TFV
• HIV incidence = 6.41/100py (95% CI: 4.9-25.8)
Adherence:
TFV-DP (fmol/punch) via DBS w/ Dosing Estimates
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Wk 4 Wk 8 Wk 12 Wk 24 W36 Wk48
>700 (4 or
more days)
350-699
(2-3 days)
<350
(2 days)
BLQ
60 52 55 32 23 28
TFV Levels in Seroconverters
0
200
400
600
800
1000
1200
Wk 4 Wk 8 Wk 12 Wk 24 Wk 36 Wk 48
Pt 1 (wk 32)
Pt 2 (wk 36)
Pt 3 (wk 48)
21
TFV-DPLevel 4+ doses
*TDF/FTC is not FDA approved for use in those <18 years oldGilead confidential and proprietary-for internal use only
23. Gilead Confidential and Proprietary—for Internal Use Only
‡
Men and Women Starting FTC/TDF for
PrEP in US, 2012 to 2015
2,740 3,708
5,051
7,313
3,470
5,315
16,855
35,232
0
5000
10000
15000
20000
25000
30000
35000
40000
2012 2013 2014 2015
4-YearTotal: 79,684
6,210
Women: 18,812
Men: 60,872
9,023
21,906
42,545
FTC/TDF (Truvada) for HIV Pre-Exposure Prophylaxis
(PrEP) Utilization in the United States: 2012−2015
Truvada® (FTC/TDF) for HIV Pre-Exposure Prophylaxis
Mera R, et al. AIDS 2016. Durban, South Africa. Oral #TUAX0105LB
‡
24. Gilead Confidential and Proprietary—for Internal Use Only
‡
HIV Biomedical Prevention Knowledge, Attitudes, and
Behavior Among U.S. Women
23
Kassaye S, et al. CROI 2018, Boston, MA. Poster #1050.
Cross sectional survey among women enrolled in WIHS to assess PEP, PrEP, and TasP
knowledge, attitudes, and behavior, 2015-2015, (N=2406)
Knowledge and use of PEP/PrEP was limited among women, but upon learning about
these methods the majority were willing to use and recommend them.
Women’s Interagency HIV Study (WIHS)
HIV (-) HIV (+) Total
Heard of PrEP
10% 16% 14%
Heard of PEP
17% 21% 20%
Would Use PrEP
68% - -
Would Use PEP
(if recommended
by a doctor)
61% - -
Willing to
undergo regular
HIV Testing
72% - -
Reasons for taking daily PrEP % of participants
“Protecting myself” 83
Having a casual partner 40
Distrust of partners 46
Having an HIV+ partner 26
Recommended by HCP 30
Factors associated with willingness to use PrEP
Younger age (OR: 0.95; 95% CI: 0.92-0.98, p=0.001)
Believes PrEP will prevent HIV (OR: 7.53; 95% CI: 2.02-28.13; p=0.0027)
Willingness to recommend PrEP to others (OR: 40; 95% CI: 21.28-76,92;
p<0.001)
25. Gilead Confidential and Proprietary—for Internal Use Only
‡
Predictors of Willingness to take PrEP among Black and
Latina Transgender Women (BLTW)
Descriptive analysis of a 2-city cohort to estimate PrEP uptake and identify
predictors of willingness to take PrEP among BLTW
24
Baltimore, MD; Washington DC
Results
201 BLTW, 86% (n=174) reported
awareness
– 80% (n=139/174) willing and knew where to get PrEP
Among 76 HIV-negative/unknown who had
not taken PrEP, 78% (59/76) were willing
but only 39% (30/76) took PrEP
History of exchange sex and legal gender
affirmation were predictors of PrEP
willingness
Reported reasons for unwillingness include:
hormone interactions, Truvada side effects,
and requiring daily doses
Poteat T, et al. CROI 2018. Boston, MA. poster # 1045
PrEP uptake improvement requires understanding the complex relationships
between gender affirmation, exchange sex and PrEP acceptability among BLTW
26. Gilead Confidential and Proprietary—for Internal Use Only
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Characteristics of Seroconverters
HIV Seroconversion Across 32 FTC/TDF PrEP Demonstration Projects
Geography (N=67)Race (N=67)
Mixed
(23)
Black
(25)
White
(14)
NR (4)Asian (1)
MSM
(54)
Mean age: 25.3 y (range: 17–49)
Risk: MSM (81%); Race: Black (37%), Mixed (34%); Location: US (43%), SA (39%)
Dried blood spot data available for 32 of 67
– 17 of 32 had TFV-DP levels BLQ
– 14 had TFV-DP levels corresponding to <2 FTC/TDF tablets per week
USA
(29)
Peru
(18)
Brazil (5)
UK (5)
S. Africa (3)
Ecuador (3)
NR (2)
Thailand (1)
Australia (1)
Female
n=1388
Male
n=7002
Transgender
n=76
FTC/TDF Exp 787.7 PY 6213.9 PY 48.4 PY
Seroconverters 2 64 1
# /100 PY
(95% CI)
0.25
(0.03-0.92)
1.03
(0.80-1.32)
2.07
(0.05-11.52)
Poor adherence is associated with an increased likelihood of seroconversion
McCallister S, et al. ASM 2016. Boston, MA. Oral
Risk Category (N=67)
MSM=64
Hetero. Women
(2)
Bisexual 1
Gilead confidential and proprietary-for internal use only
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Time to Protection with Daily Dosing of Truvada® for PrEP
WHO recommends additional HIV prevention measures should be
used for 7 days after starting daily PrEP1
Target ratios have been defined for TFV and FTC for adequate cellular
protection in genital tissue2
TRUVADA for PrEP™
1. WHO Implementation tool for pre-exposure prophylaxis (PrEP) of HIV infection. Module 1: Clinical.Geneva: World Health Organization; 2017 (WHO/HIV/2017.17)
2. Cottrell M, et al J Infect Dis. 2016 Jul 1;214(1):55
3. Kashuba A, IAS 2017, France, Paris. Symposium #MOSY0803
Time to maximal
protection is achieved by
3rd dose in FGT and by
2nd dose in RT3, well
within the WHO
recommendation of 7
days post-PrEP initiation
0
20
40
60
80
100
1 2 3 4 5 6 7 8 9 10
%AchievingEC95TargetRatio
Dose
Female Genital Tissue
(FGT)
Rectal Tissue (RT)
Maximal Protection by dose 2 in RT
Maximal Protection by dose 3 in FGT
SS % Achieving
Target in FGT
SS % Achieving
Target RT
SS, steady state
Gilead confidential and proprietary-for internal use only
28. Gilead Confidential and Proprietary—for Internal Use Only
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HIV Diagnoses Among People Who Inject Drugs (PWID)
Trends in HIV diagnoses among PWID aged ≥13 years
Lyss S, et al. CROI 2018, Boston, MA. Poster #970.
‡
The increase in HIV diagnoses among PWID between 2014-2016 in certain groups require
careful monitoring of HIV incidence, outbreak planning, and rapid, multi-modal interventions.
National HIV Surveillance System (NHSS) – United States, 2010-2016
The decline in HIV diagnoses among PWID have
slowed and perhaps stalled.
Patterns of HIV diagnoses among PWID have changed
29. Gilead Confidential and Proprietary—for Internal Use Only
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HIV Transmission Potential due to Injection Drug Use
in Rural West Virginia, 2017
Epidemiologic review (contact tracing) of an HIV infection cluster in historically low HIV-
prevalent counties in West Virginia
28
In the context of the rural opioid epidemic in the United States, timely public health
response to clusters of HIV infection in low prevalence populations is critical to
prevent HIV outbreaks among people who inject drugs.
• Most diagnoses were due to male-to-
male sexual contact, but the potential for
transmission through IVDU was
identified
• 45 subjects identified with HIV of
which 87% were male, 71% were
white and 67% were MSM. 20%
presented with AIDS at diagnosis
• 13 of 84 persons ( includes
contacts) interviewed had injected
drugs in the past year
Hogan V, et al. CROI 2018. Boston, MA. Poster #976LB
n = 27
HIV-positive
persons
diagnosed in
2017 interviewed
and not virally
suppressed
n = 17/27
Had ≥ 1 sexual or
IDU contacts with
negative or
unknown HIV
status
n = 2/17
Had ≥1 contacts
who injected
drugs and shared
equipment in the
past year
n = 3/17
Injected drugs
and shared
equipment in the
past year
Risk behaviors that could result in bridging of HIV to the PWID population
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• Individuals at high risk of acquiring HIV may continue high risk
behavior after PrEP initiation.3
• Number of sexual partners may remain stable or may increase.3,4
• Number of condomless sexual partners may increase.3,5
• Urethral, rectal, and pharyngeal STI screening is recommended every
3-6 months.2
• High STI rates in this population may be observed due to selection bias.6
• Increased screening may decrease STI incidence in this population.6
TRUVADA for PrEP™ is recommended for appropriate HIV-negative
individuals who report diagnosis of an STI or infrequent condom
use1,2.
Changes to Sexual Behavior and STI Incidence Vary
• Some real world studies identified an association between
FTC/TDF initiation and increased STI incidence.4,7-9
• Some real world studies found no association between
FTC/TDF use and STI incidence.5,10-12
HIV incidence decreased regardless of
sexual behavior, condom use, or STI
incidence.
1. TRUVADA Prescribing Information. Gilead Sciences, Inc. 2017. 2 USPHS. Pre-exposure prophylaxis for the prevention of HIV infection in the United States–2017.
https://www.cdc.gov/hiv/pdf/guidelines/cdc-hiv-PrEPguidelines-2017.pdf 3. Montano M, et al. CROI 2017; Seattle, WA. Poster #979 4. Kojima N, et al. ID Week 2016; New Orleans, LA. P504 5. White
E, et al. IAS 2017. Paris, France. Oral #TUAC0101 6. Jenness SM, et al. CROI 2017. Seattle, WA. Poster #1034 7. Mayer K, et al. IDWeek 2016; New Orleans. Oral #2379. 8. Marcus J, et al. JAIDS
2016: epub ahead of print 9. Beymer M, et al. IAS 2017. Paris, France. TUPEC0779 10. Liu A, et al. JAMA Intern Med 2016; 176(1):75-84. 11. Crouch PC, et al. IAS 2017. Durban, South Africa.
FRAE0104 12. Nakelsky S, et al. IAPAC 2017. Miami, FL. Poster #316
‡
High Risk
Population
Condom Use/
Sexual
Behavior May
Vary
Increased
Screening
STI Incidence
Varies
HIV Risk
Reduction
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Combining TRUVADA for PrEP with STI Screening
Could Decrease STI Rates
Model of co-circulating HIV, gonorrhea (NG), and chlamydia (CT) infections among
MSM in the United States based on social networks
The study suggests that the high STI rates among PrEP users may not be attributable to
Risk compensation, and may be a result of selection bias (i.e. higher risk population at
baseline combined with more frequent screening).
Method: TRUVADA indications modeled
based on CDC guidelines, adherence
based on the PrEP Demo Project, efficacy
based on iPrEx.
Results:
• Increased uptake of PrEP coupled with
routine STI screening and treatment could
lead to strong and sustained declines in
gonorrhea and chlamydia incidence and
prevalence among MSM
• At 40% TRUVADA coverage and 40% Risk
Compensation 42% of GC and 40% of CT
infections would be averted over 10 years
• A doubling in risk compensation would still
result in net STI prevention relative to no
TRUVADA
• Performing STI screening at quarterly vs.
biannual intervals would result in a further
50% reduction in incidence
Jenness SM, et al. CROI 2017. Seattle, WA. Poster #1034
RiskCompensation
% of NG Infections Averted % of CT Infections Averted
PrEP Coverage PrEP Coverage
20%
20%
40% 60% 80%
40%
60%
80%
20% 40% 60% 80%
20%
40%
60%
80%
RiskCompensation
20% 40% 60% 80%0%20% 40% 60% 80%0%
‡
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HIV Pre-Exposure Prophylaxis as a Gateway to Primary Care
Cross-sectional study of PrEP vs. non-PrEP users at Fenway Health to determine
association of PrEP with receipt of routinely recommended primary care (N=5,857)
Marcus JL, et al. CROI 2018, Boston, MA. Poster #1011.
‡
54
87
90
78
17
77
33
67
62
42
14
37
0
20
40
60
80
100
Influenza
Vaccination
Tobacco
Screening
Depression
Screening
HbA1c or
Glucose
Testing
HbA1c
Testing
Glucose
Testing
%ofpatients
PrEP No PrEP
PrEP use was associated with receipt of routinely recommended primary care.
The benefits of PrEP may extend beyond HIV prevention to behavioral and mental
health, and treatment and prevention of other infectious and chronic diseases.
Receipt of primary care by PrEP use across the study period Prevalence ratios (95% Cl) comparing receipt of primary
care between patients who were and were not prescribed
PrEP within each year
Unadjusted P Adjusted P
Influenza vaccination 1.39 (1.31-1.48) <0.001 1.57 (1.47-1.67) <0.001
Tobacco screening 1.15 (1.12-1.19) <0.001 1.13 (1.09-1.16) <0.001
Depression screening 1.34 (1.30-1.38) <0.001 1.18 (1.15-1.22) <0.001
HbA1c or glucose
testing
1.78 (1.70-1.85) <0.001 1.83 (1.75-1.92) <0.001
HbA1c testing 0.98 (0.87-1.11) 0.78 0.89 (0.79-1.01) 0.07
Glucose testing 1.94 (1.85-2.03) <0.001 2.03 (1.93-2.14) <0.001
Prevalence ratios obtained from Poisson models with generalized estimating equations.
Adjusted models included age, gender, year, race/ethnicity, and insurance type, and models for
HbA1c or glucose testing also included diabetes, hypertension, and overweight/obesity.
P<0.001 for all
except HbA1c
Testing
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HIV PrEP Pipeline by Formulation
Systemic Topical – Vaginal Topical – Rectal
Short-
Acting
Tablet
• Oral TDF/FTC daily
• Oral TDF/FTC
2/1/1 (MSM, TGW)
• Oral TAF/FTC
Vaginal Gel
• TFV BAT24 (mITT & post hoc)
• TFV daily (post hoc)
• Griffithsin/carrageenan
• PC-1005
Fast-dissolving film
• TFV film
• Dapivirine film
Fast-dissolving insert
• TFV/FTC insert
• TFV/EVG insert pre-clinical
Rectal Gel®
• TFV
• MVC
• DPV
• IQP-0528
• PC-1005
• Griffithsin/carrageenan
• *potential as lubricant
Douche
• TFV
Fast-dissolving insert
• TFV/EVG
Long-
Acting
Injectable IM
• CAB-LA q2m
Implantable SC
• TAF q12m
• CAB
Infusion IV
• bnAb q2m
Intravaginal ring (IVR)
• Dapivirine
• TFV
• TDF
• MVC
• DPV/MVC
• Pod-IVR TFV/FTC/MVC
• IVR TFV/LNG
32
Key
• Clinical efficacy established
• Clinical trial ongoing/complete
• Clinical trial pending
• Pre-clinical testing
Hendrix, et al. HIV and Women 2018. Boston, MA.
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Step 1
Daily oral CAB and
oral TDF/FTC placebo
Daily oral TDF/FTC and
oral CAB placebo
Step 2
CAB injection x 2, 4 weeks apart
then every 8 weeks
plus daily oral TDF/FTC placebo
Placebo injection x 2, 4 weeks apart
then every 8 weeks
plus daily oral TDF/FTC
Step 3
Open-label daily oral TDF/FTC to
cover the PK tail, for up to 48 weeks
CAB
HPTN 083HPTN 083: Efficacy of injectable Cabotegravir
(CAB) for PrEP in MSM and transgender women
TDF/FTC
• N = 4500; Enrolled = 600
• Goals: 10% TGW overall; 50% of US BMSM; 50% overall < 30 year old
• Study duration: 3-5 years
• Sites in North and South America; Asia; SSA (limited)
Primary objective: HIV Incidence
HPTN 084- Efficacy of Injectible Cabotegravir for PrEP in HIV-uninfected
Women Vs TVD. SSA. DB Superiority study. 1:1 Randomization.
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Efficacy of Long Acting Cabotegravir in Macaques
Against Repeated Penile SHIV Exposures
PK analysis and penile SHIV challenge of cabotegravir in Rhesus macaques, (N=6)
34
Dobard C, et al. CROI 2018. Boston, MA. Oral #83
• Three monthly IM injections (50
mg/kg) to maintain CAB levels in
plasma above 4x PA-IC90
• Challenge once-weekly (12 weeks);
20 week washout
- SHIV162p3 exposures to
urethra (16 TCID50) and
prepuce pouch (200 TCID50)
• Plasma collected weekly to monitor
CAB levels and SHIV RNA Drug tail
Cabotegravir long acting effectively protects macaques against penile
SHIV infection
36. Gilead Confidential and Proprietary—for Internal Use Only
DISCOVER: Pivotal Study F/TAF vs TVD for PrEP
Eligibility: HIV and HBV negative, eGFR ≥60 mL/min, and at least one of the following:
– 2+ episodes condomless anal intercourse (past 12 wks),
– or rectal gonorrhea/chlamydia (past 24 wks)
– or syphilis (past 24 wks)
Sample size N=5000 to show noninferiority (F/TDF vs F/TAF) assumes 1.4/100 p-y seroconversion rate for
F/TDF arm; 144 seroconversions needed to demonstrate NI
Sites: sexual health clinics, medical offices (North America, EU)
n=2500
n=2500
Primary Endpoint:
Seroconversion rate/100 p-y
Week 0 9648
F/TAF (200/25 mg) QD
TVD (200/300 mg) QD
72
F/TAF
Switch option
Participants, N
Screened 5,902
Enrolled 5,400
DXA sub-study 373
Adult cis MSM or
TGW
HIV negative
Gilead confidential and proprietary-for internal use only
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SHIV162p3
FTC/TAF
(-24h)
FTC/TAF
(+2h)
Treated group
(n=6 pigtails)
SHIV162p3
Placebo
(-24h)
Placebo
(+2h)
Control group
(n=6 pigtails)
Repeated once a week during 16 weeks
36
Phase II: Efficacy of FTC/TAF Against Vaginal SHIV Infection
• Pigtailed macaques ( 11.5 years old and 9.0 kg on average)
• Repeated exposures to low (50 TCID50) doses of SHIV162p3
• Design identical to previous studies with FTC/TDF (-24h/+2h modality; 6/6
animals protected; Radzio et al., PLoS One 2012).
• FTC/TAF (20/1.5 mg/kg) administered orally by gavage
• Infection monitored weekly by serology and RT-PCR
Massud I, et al. CROI 2018. Boston, MA. Oral #85.
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High Efficacy of FTC/TAF Against Vaginal SHIV Infection
p =0.0422 (Log-rank test)
Efficacy: 82%
Oral FTC/TAF
Placebo controls
0 4 8 12 16
0
50
100
Number of virus exposures
Percentsurvival
37Massud I, et al. CROI 2018. Boston, MA. Oral #85.
39. Gilead Confidential and Proprietary—for Internal Use Only
‡
Median (range) fmols/106 cells in PBMCs through weeks 1-16 of virus challenges
LOQ: TFV-DP 12 fmol/million, FTC-TP 3 fmol/million
BLQ: below limit of quantification
TFV-DP in PBMC
weeks
fmol/10
6
cells
1 2 3 4 5 6 7 8
1
10
100
1000
10000
14 15
BB0496
BB766
PCG1
BB0550
PBL2
PUG2
median
FTC-TP in PBMC
weeks
fmol/106
cells
1 2 3 4 5 6 7 8
1
10
100
1000
10000
14 15
BB0496
BB766
PCG1
BB0550
PBL2
PUG2
median
38
TFV-DP and FTC-TP Levels During the Virus Challenges
BB0496 BB766 PCG1 BB0550 PBL2 PUG2
FTC-TP TFV-DP FTC-TP TFV-DP FTC-TP TFV-DP FTC-TP TFV-DP FTC-TP TFV-DP FTC-TP TFV-DP
1,255
(388.0-
1,899)
123
(66.9-
167.7)
1,641
(1,386-
2,500)
199
(130.4-
246.5)
1,837
(1,116-
2,127)
237
(195.3-
257.0)
1,499
(1,092-
1,760)
BLQ 2,124
(1,101-
2,748)
829
(339.7-
1,364)
2,653
(2,068-
3,162)
298
(179.1-
370.7)
Massud I, et al. CROI 2018. Boston, MA. Oral #85.
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MK-8591-treated animals remain aviremic after
168 days of study
MK-8591 treated animals have a 41.5-fold lower risk of infection (95% C.I. 7.3, 237.9)
P<0.0001 log rank test
Markowitz, M. : Weekly Oral MK-8591 Protects Male Rhesus Macaques against Repeated Low Dose Intrarectal
Challenge with SHIV109CP3. IAS 2017
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Low Dose MK-8951 Protects Rhesus Macaques Against
Rectal SHIV Infection
PK analysis and rectal SHIV challenge of MK-8951 in Rhesus macaques, (N=8)
40
Markwoitz M, et al. CROI 2018. Boston, MA. Oral #89LB
MK-8591 remains completely protective at 1.3 and 0.43 mg/kg in
the rhesus macaque intrarectal challenge model.
42. Gilead Confidential and Proprietary—for Internal Use Only
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Broadly neutralizing Antibodies
Gilead confidential and proprietary-for internal use only
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Efficacy of Broadly Neutralizing Antibodies (BNAbs) in
Macaques Against Repeated Vaginal SHIV Exposures
PK analysis and vaginal SHIV challenge in Rhesus macaques dosed weekly with a single
(3BNC117) or combo (3BNC117 + 10-1074) BNAb injection, (N=12)
42
Garber D, at al. CROI 2018. Boston MA. Oral #82
One subcutaneous administration of 3BNC117 singly, or in combination with 10-1074,
protected macaques against repeated vaginal challenges, supporting the continued
development of these two BNAbs for HIV prevention in women.
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TFPD Injectable for Prevention (TIP) Program-UC Berkeley
and RTI
Controlled release of ARV
for HIV PrEP
– User-independent
– Provider administered
– Discretion of use
Subcutaneously injected
– Appropriate for women and
men
– Protection from all sexual
routes of exposure
Biodegradable
Removable
Gilead confidential and
proprietary-for internal use only
Prototype Thin Film Polymer Devices
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Osmotic Pump
• This osmotic flow is directly proportional to the gradient of
concentration of osmolytes in the osmotic chamber.
• The inward H2O flow creates an increased pressure in the osmotic
chamber, which exerts a force on the piston.
• The osmolyte must be included in a supersaturated form, to maintain
its constant concentration of despite the inward flow of H2O
Gilead confidential and proprietary-for internal use only
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Osmotic Pump
Gilead confidential and proprietary-for internal use only
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Name Date
NANOCHANNELS:
NO NEED FOR PUMPS!
Diffusion
Free -> Exponential
Constrained:
Constant
Parallel and highly reproducible
industrial microfabrication of
nanochannel membranes
Nanochannel membranes bio-robust structure
with geometrically organized – monodisperse
nanochannels: dimensional tolerances 0.2 nm
Constant drug release achieved with no
pumping mechanism across nanochannels
by leveraging physical and electrostatic
confinement on diffusing drug molecules
Implantable nanochannel delivery systems containing a drug reservoir and mounting a nanochannel membrane as release rate
modulating component (A). In analogy to an hour-glass the implants release their drug constantly until the drug is fully released (B).
Great flexibility of implants and membranes to accommodate any size, shape, release rate for suitable for a variety of clinical
applications (C). Implants allow for transcutaneous reloading of the drug for extended treatments without need for explantation (D).
The implant can include a system that allows for permanently interrupting the drug release ad hoc by using a portable external
A B C D E