Pre and Post Exposure Prophylaxis and HIV Prevention presented by Dr. Ken Mayer, Research Director of the Fenway Health Center at the Fenway Health Center community education conference: An End To AIDS - How A State Bill Can Change Everything hosted by SearchForACure.org, the Fenway Health Center, and the MA Dept. of Public Health
Современное лечение ВИЧ.Объединенные данные с конференции IAS 2019 / Contemp...hivlifeinfo
Review key HIV data from IAS 2019 on the updated NTD risk in women receiving ART at conception, PrEP, first-line and switch options, and early-phase investigational strategies.
Clinical Impact of New Data From IAS 2019hivlifeinfo
July 21-24, 2019; Mexico City, Mexico
Download slide highlights of key studies addressing current issues in HIV care, as reported at this important annual conference.
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016hivlifeinfo
In this downloadable slideset, Eric S. Daar, MD, and Paul E. Sax, MD, review recent updates to expert guideline recommendations for ART—including new initial therapy recommendations, revised guidance on switch strategies for virologically suppressed patients, and other key recommendation updates.
Format: Microsoft PowerPoint (.ppt)
File size: 1.09 MB
Date posted: 9/19/2016
Mackenzie Cottrell, PharmD
Assistant Professor
Co-Director of the UNC CFAR Clinical Pharmacology and Analytical Chemistry Core
Division of Pharmacotherapy and Experimental Therapeutics
University of North Carolina at Chapel Hill
Clinical Impact of New Data From AIDS 2020hivlifeinfo
current ART in principal populations, including older patients and women who become pregnant; metabolic outcomes during ART; HIV and COVID-19; investigational ART strategies; and HIV prevention.
The iPrEx trial found that daily oral Truvada (tenofovir/emtricitabine) reduced the risk of HIV infection by 44% among men who have sex with men when combined with comprehensive prevention services. Adherence was high at 95% but effectiveness was greater for those with consistent adherence above 90%. While daily Truvada was generally safe and well tolerated, its long term safety beyond the trial is unknown as is its effectiveness for other populations, routes of transmission, and outside of a clinical trial setting. Some questions remain around true risk of drug resistance and side effects with real world use.
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...hivlifeinfo
Слайды с последними данные и рекомендациями по выбору АРТ, как для пациентов, ранее не получавших лечения, так и пациентов с вирусологической супрессией. Оценки разных вариантов лечения, индивидуализация АРТ для женщин детородного возраста и во время беременности, пациентов с опортунистическими инфекциями и новые данные об исследовательских стратегиях АРТ.
Современное лечение ВИЧ.Объединенные данные с конференции IAS 2019 / Contemp...hivlifeinfo
Review key HIV data from IAS 2019 on the updated NTD risk in women receiving ART at conception, PrEP, first-line and switch options, and early-phase investigational strategies.
Clinical Impact of New Data From IAS 2019hivlifeinfo
July 21-24, 2019; Mexico City, Mexico
Download slide highlights of key studies addressing current issues in HIV care, as reported at this important annual conference.
HIV Alert :Updating Your Practice Based on New Guideline Recommendations.2016hivlifeinfo
In this downloadable slideset, Eric S. Daar, MD, and Paul E. Sax, MD, review recent updates to expert guideline recommendations for ART—including new initial therapy recommendations, revised guidance on switch strategies for virologically suppressed patients, and other key recommendation updates.
Format: Microsoft PowerPoint (.ppt)
File size: 1.09 MB
Date posted: 9/19/2016
Mackenzie Cottrell, PharmD
Assistant Professor
Co-Director of the UNC CFAR Clinical Pharmacology and Analytical Chemistry Core
Division of Pharmacotherapy and Experimental Therapeutics
University of North Carolina at Chapel Hill
Clinical Impact of New Data From AIDS 2020hivlifeinfo
current ART in principal populations, including older patients and women who become pregnant; metabolic outcomes during ART; HIV and COVID-19; investigational ART strategies; and HIV prevention.
The iPrEx trial found that daily oral Truvada (tenofovir/emtricitabine) reduced the risk of HIV infection by 44% among men who have sex with men when combined with comprehensive prevention services. Adherence was high at 95% but effectiveness was greater for those with consistent adherence above 90%. While daily Truvada was generally safe and well tolerated, its long term safety beyond the trial is unknown as is its effectiveness for other populations, routes of transmission, and outside of a clinical trial setting. Some questions remain around true risk of drug resistance and side effects with real world use.
Ключевые слайды по индивидуальному выбору АРТ / Key Slides on Individualized ...hivlifeinfo
Слайды с последними данные и рекомендациями по выбору АРТ, как для пациентов, ранее не получавших лечения, так и пациентов с вирусологической супрессией. Оценки разных вариантов лечения, индивидуализация АРТ для женщин детородного возраста и во время беременности, пациентов с опортунистическими инфекциями и новые данные об исследовательских стратегиях АРТ.
Journal club presentation: by RxVichuZ!! ;)RxVichuZ
My 97th powerpoint... deals with the comparative study of efficacy of piperacillin-tazobactam, as compared to meropenem in the treatment of ESBL(Extended spectrum beta-lactamases) infections.
A summarized insight has been provided, using research article from JAMA.
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...hivlifeinfo
This document discusses several new HIV treatment regimens approved between 2017-2019, including three-drug fixed-dose combinations of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COBI/FTC/TAF). Clinical trials showed BIC/FTC/TAF and DOR/3TC/TDF were
Highlights of IAS 2013.CCO Official Conference Coverage of the 7th IAS Confer...Hivlife Info
The document summarizes highlights from the 7th IAS Conference on HIV Pathogenesis, Treatment, and Prevention held in Kuala Lumpur, Malaysia in June-July 2013. Key findings included the WHO updating treatment guidelines to recommend initiating ART at CD4 counts ≤500 cells/mm3 and preferring TDF+3TC(FTC)+EFV as the initial regimen. Studies found noninferiority of 400mg EFV and demonstrated the efficacy of second-line LPV/r-based ART and PrEP with TDF in specific populations. Adherence to treatment was an important factor in outcomes.
Gene therapy using an AAV vector was tested in 6 males with severe hemophilia B. The vector encoded Factor IX and was administered via peripheral vein infusion. No safety issues were found regarding germline transmission or formation of antibodies against FIX. Mild, transient elevations in liver enzymes occurred in some subjects. FIX levels increased in a dose-dependent manner, allowing 4 subjects to stop prophylactic FIX treatment without bleeding. While the study demonstrated proof-of-concept for hemophilia B gene therapy, larger trials are needed to further evaluate safety and efficacy.
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...hivlifeinfo
This document discusses modifying antiretroviral therapy (ART) in virologically suppressed patients with HIV. It describes two phase 3 trials, ATLAS and FLAIR, that evaluated switching to long-acting injectable cabotegravir plus rilpivirine (CAB/RPV) every 4 weeks in suppressed patients. Both trials found CAB/RPV to be noninferior to continued oral ART at 48 weeks. Common reasons to consider an ART switch include simplifying regimens or improving tolerability. Key factors that may increase risk of treatment failure with CAB/RPV include presence of rilpivirine resistance mutations at baseline and lower rilpivirine drug levels. The FDA
Update on HIV Prevention Issues Presented at 2016 CROI
Helen King MD
Jill Blumenthal MD
Susannah Graves MD
May 13, 2016
UCSD HIV & Global Health Rounds
The document summarizes information about HIV, its life cycle, approved antiretroviral drugs, adverse effects of antiretrovirals, lipodystrophy, drug interactions, and guidelines for initiating antiretroviral therapy in special populations. It provides details on the classes of antiretrovirals including nucleoside and non-nucleoside reverse transcriptase inhibitors, protease inhibitors, fusion inhibitors, CCR5 antagonists. It discusses the rationale for combination antiretroviral therapy and boosted protease inhibitors.
- Large prospective studies with over 500 patients and 5 years of follow up have shown that CyberKnife is as effective as long course radiation therapy for localized prostate cancer.
- SBRT/CyberKnife is now the standard of care treatment for localized prostate cancer.
- Outcomes from CyberKnife treatment are similar to long course radiation therapy but side effects are less than 1% for prostate cancer.
- CyberKnife provides a safe, outpatient treatment option in both primary and metastatic disease using short treatment courses and high radiation doses that can be effective for radioresistant diseases.
This document provides an overview and summary of recent data on antiretroviral therapy (ART) for HIV. Key findings include:
- A study in Thailand found that daily oral tenofovir reduced HIV infection risk among injection drug users by 48.9%, leading to new guidelines recommending PrEP for high-risk drug users.
- US demonstration projects found high adherence to PrEP among at-risk populations, with tenofovir levels indicating protection.
- Multiple studies found dolutegravir to be superior to other regimens in suppressing HIV and had fewer side effects, establishing it as a preferred integrase inhibitor.
- No transmissions occurred in a large study of serod
HPV infection and anal dysplasia in Vancouver: findings from the ManCount Survey.CBRC
This document summarizes preliminary findings from the ManCount Survey regarding HPV infection and anal dysplasia in gay and bisexual men in Vancouver. Rectal swabs were self-collected by 252 survey participants. The results found that 38% tested negative for HPV and 47% tested positive for high-risk HPV types. Abnormal anal cytology results were found in 11% (high-grade) and 19% (low-grade). The next steps will analyze these preliminary medical findings together with behavioral data to inform policies around HPV vaccination and anal pap screening for men who have sex with men.
Highlights of AIDS 2014 .CCO Official Conference Coverage of the 20th Interna...Hivlife Info
The document summarizes highlights from the 20th International AIDS Conference held in Melbourne, Australia in July 2014. It includes results from several clinical trials presented at the conference evaluating new antiretroviral regimens for initial therapy and treatment switches in suppressed patients. One study found maraviroc plus darunavir/ritonavir was not non-inferior to tenofovir/emtricitabine plus darunavir/ritonavir for initial therapy. Another study found switching suppressed patients to a dual regimen of lopinavir/ritonavir plus lamivudine or emtricitabine was non-inferior to continuing a triple regimen. A sub-
Michael Festing - MedicReS World Congress 2011MedicReS
The document discusses principles of animal experimentation and summarizes some key points:
- 93% of research involves mice, fish and rats. Animal experiments have led to advances like vaccines, antibiotics, organ transplants, and treatments for diseases.
- Countries have animal welfare laws that encourage humane experimentation and oversight. Experiments use animal models to study effects in humans. Results only apply to the model species.
- The minimum number of animals should be used according to the principles of replacement, refinement and reduction. Statistical quality and design of some published animal studies has room for improvement.
- Using multiple inbred strains in toxicity testing could increase power over using a single outbred stock, with similar or smaller
HIV Alert:Новые стратегии и агенты в лечении ВИЧ/Novel Strategies and Agents ...hivlifeinfo
HIV Alert-Новые стратегии и агенты в лечении ВИЧ/Novel Strategies and Agents for HIV Management.2017
In this downloadable slideset, Daniel R. Kuritzkes, MD, and Paul E. Sax, MD, review potential future HIV treatment strategies—including dual-therapy regimens, long-acting ART, and investigational agents—and discuss where these might fit into the current therapeutic landscape.
Format: Microsoft PowerPoint (.ppt)
File size: 570 KB
Date posted: 9/27/2017
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014Hivlife Info
This document summarizes a presentation on new agents for treating hepatitis C virus (HCV) infection in patients coinfected with HIV. It discusses FDA-approved regimens containing simeprevir or sofosbuvir, dosing and administration, treatment guidelines from AASLD/IDSA, and clinical trial data on sofosbuvir and simeprevir in HIV/HCV coinfected patients, showing high sustained virologic response rates.
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...WAidid
The slideset offers an overview of MDR-TB: the epidemiology, the efficacy of the available treatments, and the new perspectives in the management of the pathology.
The slideset underlines, moreover, the existence of a free cost online instrument developed by ERS together with WHO to help clinician from all Europe to manage difficult-to-treat TB cases: TB Consilium.
What’s New in Coformulated Antiretroviral Regimens.2014Hivlife Info
Andrew R. Zolopa, MD, discusses how new agents are contributing to the development of novel coformulated antiretroviral agents and regimens.
Format: Microsoft PowerPoint (.ppt)
File size: 1.33 MB
This study assessed the efficacy and safety of the all-oral combination of daclatasvir plus asunaprevir for chronic hepatitis C virus genotype 1b infection. It included 307 treatment-naive patients, 205 previous non-responders to interferon-based therapy, and 235 patients ineligible or intolerant to interferon-based therapy. Treatment with daclatasvir plus asunaprevir for 12-24 weeks provided sustained virologic response in 90% of treatment-naive patients, 82% of previous non-responders, and 82% of ineligible/intolerant patients. The regimen was well tolerated with few serious adverse events or discontinuations across the cohorts. This study supports the use
Sepsis and antibiotic guidance in neurology wardsDivya Shilpa
1) A one-time survey in a neurology ward and ICU found that 15 out of 69 patients (21.73%) had sepsis. Common organisms found included Klebsiella, Enterobacter, Pseudomonas, Acinetobacter, and E. coli.
2) Guidelines for treating ventriculostomy-associated infections recommend intravenous and intraventricular antibiotics such as vancomycin. Combined treatment may improve outcomes over intravenous antibiotics alone.
3) Post-stroke infections are common, with reported rates around 30%. Pneumonia is the most frequent type of infection and is associated with increased mortality. Preventive antibiotics may reduce infection rates but not affect mortality.
This document summarizes a presentation on microbicide drug candidates for HIV prevention. It begins with introducing the high burden of HIV/AIDS globally and in sub-Saharan Africa and Southeast Asia, particularly among women. It then provides an overview of various existing HIV prevention methods and their limitations. The rationale for developing microbicides is described as addressing the insufficiency and acceptability issues of other methods. Microbicides are classified and their mechanisms of action are explained. The stages of microbicide development including preclinical and clinical trial phases are outlined. Current clinical trial results showing promising efficacy of tenofovir gel are summarized. Remaining challenges in microbicide development are noted along with recommendations to continue research efforts.
This document provides an introduction to human resource management. It defines HRM as the management function aimed at ensuring the availability of competent and committed workforce. The key functions of HRM include staffing, development, compensation and motivation, and maintenance and integration. HRM has evolved over time due to factors such as scientific management theories, technology changes, and the growing knowledge workforce. Both external environmental factors and internal organizational factors shape the practice of HRM.
Journal club presentation: by RxVichuZ!! ;)RxVichuZ
My 97th powerpoint... deals with the comparative study of efficacy of piperacillin-tazobactam, as compared to meropenem in the treatment of ESBL(Extended spectrum beta-lactamases) infections.
A summarized insight has been provided, using research article from JAMA.
Incorporating New ART Options Into First-line and Switch Strategies for HIV C...hivlifeinfo
This document discusses several new HIV treatment regimens approved between 2017-2019, including three-drug fixed-dose combinations of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF), and darunavir/cobicistat/emtricitabine/tenofovir alafenamide (DRV/COBI/FTC/TAF). Clinical trials showed BIC/FTC/TAF and DOR/3TC/TDF were
Highlights of IAS 2013.CCO Official Conference Coverage of the 7th IAS Confer...Hivlife Info
The document summarizes highlights from the 7th IAS Conference on HIV Pathogenesis, Treatment, and Prevention held in Kuala Lumpur, Malaysia in June-July 2013. Key findings included the WHO updating treatment guidelines to recommend initiating ART at CD4 counts ≤500 cells/mm3 and preferring TDF+3TC(FTC)+EFV as the initial regimen. Studies found noninferiority of 400mg EFV and demonstrated the efficacy of second-line LPV/r-based ART and PrEP with TDF in specific populations. Adherence to treatment was an important factor in outcomes.
Gene therapy using an AAV vector was tested in 6 males with severe hemophilia B. The vector encoded Factor IX and was administered via peripheral vein infusion. No safety issues were found regarding germline transmission or formation of antibodies against FIX. Mild, transient elevations in liver enzymes occurred in some subjects. FIX levels increased in a dose-dependent manner, allowing 4 subjects to stop prophylactic FIX treatment without bleeding. While the study demonstrated proof-of-concept for hemophilia B gene therapy, larger trials are needed to further evaluate safety and efficacy.
Современное лечение ВИЧ: модификация АРТ у пациентов с вирусологической супре...hivlifeinfo
This document discusses modifying antiretroviral therapy (ART) in virologically suppressed patients with HIV. It describes two phase 3 trials, ATLAS and FLAIR, that evaluated switching to long-acting injectable cabotegravir plus rilpivirine (CAB/RPV) every 4 weeks in suppressed patients. Both trials found CAB/RPV to be noninferior to continued oral ART at 48 weeks. Common reasons to consider an ART switch include simplifying regimens or improving tolerability. Key factors that may increase risk of treatment failure with CAB/RPV include presence of rilpivirine resistance mutations at baseline and lower rilpivirine drug levels. The FDA
Update on HIV Prevention Issues Presented at 2016 CROI
Helen King MD
Jill Blumenthal MD
Susannah Graves MD
May 13, 2016
UCSD HIV & Global Health Rounds
The document summarizes information about HIV, its life cycle, approved antiretroviral drugs, adverse effects of antiretrovirals, lipodystrophy, drug interactions, and guidelines for initiating antiretroviral therapy in special populations. It provides details on the classes of antiretrovirals including nucleoside and non-nucleoside reverse transcriptase inhibitors, protease inhibitors, fusion inhibitors, CCR5 antagonists. It discusses the rationale for combination antiretroviral therapy and boosted protease inhibitors.
- Large prospective studies with over 500 patients and 5 years of follow up have shown that CyberKnife is as effective as long course radiation therapy for localized prostate cancer.
- SBRT/CyberKnife is now the standard of care treatment for localized prostate cancer.
- Outcomes from CyberKnife treatment are similar to long course radiation therapy but side effects are less than 1% for prostate cancer.
- CyberKnife provides a safe, outpatient treatment option in both primary and metastatic disease using short treatment courses and high radiation doses that can be effective for radioresistant diseases.
This document provides an overview and summary of recent data on antiretroviral therapy (ART) for HIV. Key findings include:
- A study in Thailand found that daily oral tenofovir reduced HIV infection risk among injection drug users by 48.9%, leading to new guidelines recommending PrEP for high-risk drug users.
- US demonstration projects found high adherence to PrEP among at-risk populations, with tenofovir levels indicating protection.
- Multiple studies found dolutegravir to be superior to other regimens in suppressing HIV and had fewer side effects, establishing it as a preferred integrase inhibitor.
- No transmissions occurred in a large study of serod
HPV infection and anal dysplasia in Vancouver: findings from the ManCount Survey.CBRC
This document summarizes preliminary findings from the ManCount Survey regarding HPV infection and anal dysplasia in gay and bisexual men in Vancouver. Rectal swabs were self-collected by 252 survey participants. The results found that 38% tested negative for HPV and 47% tested positive for high-risk HPV types. Abnormal anal cytology results were found in 11% (high-grade) and 19% (low-grade). The next steps will analyze these preliminary medical findings together with behavioral data to inform policies around HPV vaccination and anal pap screening for men who have sex with men.
Highlights of AIDS 2014 .CCO Official Conference Coverage of the 20th Interna...Hivlife Info
The document summarizes highlights from the 20th International AIDS Conference held in Melbourne, Australia in July 2014. It includes results from several clinical trials presented at the conference evaluating new antiretroviral regimens for initial therapy and treatment switches in suppressed patients. One study found maraviroc plus darunavir/ritonavir was not non-inferior to tenofovir/emtricitabine plus darunavir/ritonavir for initial therapy. Another study found switching suppressed patients to a dual regimen of lopinavir/ritonavir plus lamivudine or emtricitabine was non-inferior to continuing a triple regimen. A sub-
Michael Festing - MedicReS World Congress 2011MedicReS
The document discusses principles of animal experimentation and summarizes some key points:
- 93% of research involves mice, fish and rats. Animal experiments have led to advances like vaccines, antibiotics, organ transplants, and treatments for diseases.
- Countries have animal welfare laws that encourage humane experimentation and oversight. Experiments use animal models to study effects in humans. Results only apply to the model species.
- The minimum number of animals should be used according to the principles of replacement, refinement and reduction. Statistical quality and design of some published animal studies has room for improvement.
- Using multiple inbred strains in toxicity testing could increase power over using a single outbred stock, with similar or smaller
HIV Alert:Новые стратегии и агенты в лечении ВИЧ/Novel Strategies and Agents ...hivlifeinfo
HIV Alert-Новые стратегии и агенты в лечении ВИЧ/Novel Strategies and Agents for HIV Management.2017
In this downloadable slideset, Daniel R. Kuritzkes, MD, and Paul E. Sax, MD, review potential future HIV treatment strategies—including dual-therapy regimens, long-acting ART, and investigational agents—and discuss where these might fit into the current therapeutic landscape.
Format: Microsoft PowerPoint (.ppt)
File size: 570 KB
Date posted: 9/27/2017
The Role of New HCV Agents in Managing HIV/HCV Coinfection.2014Hivlife Info
This document summarizes a presentation on new agents for treating hepatitis C virus (HCV) infection in patients coinfected with HIV. It discusses FDA-approved regimens containing simeprevir or sofosbuvir, dosing and administration, treatment guidelines from AASLD/IDSA, and clinical trial data on sofosbuvir and simeprevir in HIV/HCV coinfected patients, showing high sustained virologic response rates.
New perspectives in the treatment of multidrug-resistant tuberculosis - Profe...WAidid
The slideset offers an overview of MDR-TB: the epidemiology, the efficacy of the available treatments, and the new perspectives in the management of the pathology.
The slideset underlines, moreover, the existence of a free cost online instrument developed by ERS together with WHO to help clinician from all Europe to manage difficult-to-treat TB cases: TB Consilium.
What’s New in Coformulated Antiretroviral Regimens.2014Hivlife Info
Andrew R. Zolopa, MD, discusses how new agents are contributing to the development of novel coformulated antiretroviral agents and regimens.
Format: Microsoft PowerPoint (.ppt)
File size: 1.33 MB
This study assessed the efficacy and safety of the all-oral combination of daclatasvir plus asunaprevir for chronic hepatitis C virus genotype 1b infection. It included 307 treatment-naive patients, 205 previous non-responders to interferon-based therapy, and 235 patients ineligible or intolerant to interferon-based therapy. Treatment with daclatasvir plus asunaprevir for 12-24 weeks provided sustained virologic response in 90% of treatment-naive patients, 82% of previous non-responders, and 82% of ineligible/intolerant patients. The regimen was well tolerated with few serious adverse events or discontinuations across the cohorts. This study supports the use
Sepsis and antibiotic guidance in neurology wardsDivya Shilpa
1) A one-time survey in a neurology ward and ICU found that 15 out of 69 patients (21.73%) had sepsis. Common organisms found included Klebsiella, Enterobacter, Pseudomonas, Acinetobacter, and E. coli.
2) Guidelines for treating ventriculostomy-associated infections recommend intravenous and intraventricular antibiotics such as vancomycin. Combined treatment may improve outcomes over intravenous antibiotics alone.
3) Post-stroke infections are common, with reported rates around 30%. Pneumonia is the most frequent type of infection and is associated with increased mortality. Preventive antibiotics may reduce infection rates but not affect mortality.
This document summarizes a presentation on microbicide drug candidates for HIV prevention. It begins with introducing the high burden of HIV/AIDS globally and in sub-Saharan Africa and Southeast Asia, particularly among women. It then provides an overview of various existing HIV prevention methods and their limitations. The rationale for developing microbicides is described as addressing the insufficiency and acceptability issues of other methods. Microbicides are classified and their mechanisms of action are explained. The stages of microbicide development including preclinical and clinical trial phases are outlined. Current clinical trial results showing promising efficacy of tenofovir gel are summarized. Remaining challenges in microbicide development are noted along with recommendations to continue research efforts.
This document provides an introduction to human resource management. It defines HRM as the management function aimed at ensuring the availability of competent and committed workforce. The key functions of HRM include staffing, development, compensation and motivation, and maintenance and integration. HRM has evolved over time due to factors such as scientific management theories, technology changes, and the growing knowledge workforce. Both external environmental factors and internal organizational factors shape the practice of HRM.
This document provides an overview of human resource management (HRM). It defines HRM as the process of acquiring, retaining, terminating, developing and using human resources to achieve organizational objectives. The document outlines the meaning, definitions, objectives, nature, features, importance, process, recent trends, roles, duties, scope and functions of HRM. It also discusses the qualifications needed for a human resource manager.
The document discusses the history and transmission of HIV/AIDS, noting that the first case was reported in the US in 1981 and over 1 million people had been infected by 2001, with over 400,000 deaths. It emphasizes that HIV can infect anyone and explains that the virus is most often transmitted through unprotected sex and contact with infected bodily fluids. The text provides information on testing, treatment, and prevention methods like condom use and advises readers not to believe HIV is not serious, as there is currently no cure.
HIV/AIDS refers to acquired immunodeficiency syndrome (AIDS) caused by the human immunodeficiency virus (HIV). HIV attacks the immune system, leaving individuals susceptible to infections over time. The document discusses the definition of HIV/AIDS, how HIV is transmitted, signs and symptoms of infection, worldwide impact of AIDS, and strategies for prevention through risk avoidance and reduction.
This document discusses the key functions of human resource management including planning, organizing, directing, and controlling personnel. It outlines the managerial functions of recruitment, training and development, remuneration, motivation, and maintaining employee records. Finally, it mentions the importance of industrial relations and ensuring proper separation from employees when they leave the organization.
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.
Новые данные с конференции по ВИЧ-инфекции CROI 2017/Clinical Impact of New D...hivlifeinfo
Clinical Impact of New Data From CROI 2017
Expert faculty members Joel E. Gallant, MD, MPH, and Charles B. Hicks, MD, summarize key studies from this important annual conference.
Format: Microsoft PowerPoint (.ppt)
File size: 1.25 MB
Date posted: 3/3/2017
This document summarizes research on pre-exposure prophylaxis (PrEP) and discusses strategies for implementing PrEP. It finds that PrEP has been shown to effectively reduce HIV transmission in multiple clinical trials involving men who have sex with men, heterosexual men and women, and serodiscordant couples. However, concerns have been raised about side effects, risk compensation, and drug resistance that could present barriers to implementation. The document recommends that PrEP be implemented as part of combination prevention, with behavioral interventions to support adherence, and monitoring systems to track side effects, risk behaviors, and drug resistance. It also addresses regulatory approval, coverage under the Affordable Care Act, and targeting high-risk groups to maximize the
The 18th International AIDS Conference (AIDS 2010)Abhishek Shah
The document summarizes key findings from the 18th International AIDS Conference held in Vienna, Austria in July 2010. Some of the main topics discussed include:
- The Vienna Declaration calling for decriminalization of drug use and scaling up HIV prevention and treatment services.
- Studies showing reduced HIV risk with male circumcision and use of tenofovir gel.
- Ongoing PrEP trials evaluating daily oral tenofovir for HIV prevention.
- Modeling suggesting universal HIV testing and treatment could reduce new infections and deaths in South Africa over 40 years.
Clinical Impact of New HIV Data From CROI 2019hivlifeinfo
March 4-7, 2019; Seattle, Washington
In this downloadable slideset, expert faculty members summarize key studies from this important annual conference.
Format: Microsoft PowerPoint (.ppt)
File Size: 576 KB
Released: March 22, 2019
This 3-sentence summary provides the essential information from the document:
The document outlines a conference program from June 30 - July 3, 2013 in Kuala Lumpur, Malaysia called IAS 2013, which covered highlights and official coverage of HIV pathogenesis, treatment, and prevention. It includes slides on antiretroviral therapy guidelines, clinical trials of new drugs and regimens, and investigational long-acting antiretroviral agents. The
Cовременное лечение ВИЧ : новые данные с конференции CROI 2017/ Contemporary...hivlifeinfo
Cовременное лечение ВИЧ : новые данные с конференции CROI 2017/ Contemporary Management of HIV. New Data From CROI 2017
In this downloadable slideset, Charles B. Hicks, MD, and Program Director Joseph J. Eron, Jr., MD, review key new HIV data presented at the Seattle 2017 meeting.
Topics include:
-Prevention
-New data on currently available ART
-Switch/simplification strategies for virologically suppressed patients
-Investigational ARV agents
-Treatment complications and comorbidities
CHAMP Monthly Teleconference Training - PrEP's the Word: Everyone's Talking About It... But What Do We Need To Know, And Do, About Pre-Exposure Prophylaxis
Aidsrounds121412morris 121214115641-phpapp01Lucas Brown
The UC San Diego AntiViral Research Center sponsors weekly presentations by infectious disease clinicians and researchers to provide the most current research, clinical practices, and trends in HIV and other infectious diseases. The slides from an AIDS Clinical Rounds presentation are intended for educational purposes of the audience and may not be used without the presenter's permission. The presentation provides an update on PrEP (pre-exposure prophylaxis) for HIV, including data on efficacy from recent studies, pharmacology, adverse events, and guidance for its use.
This document summarizes an expert panel discussion on innovative antiretroviral therapy (ART) paradigms. The panel discussed whether positive results from two-drug and long-acting injectable regimens in clinical trials will translate to long-term efficacy and safety. They also considered the potential risks of resistance emerging with two-drug regimens and the impact of missed doses with long-acting injectables. The panel agreed that maintaining cold storage requirements for long-acting injectables may pose challenges for implementation in low- and middle-income countries but that qualitative research found patients highly satisfied with the convenience of long-acting ART.
Management of HIV - Post-Exposure Prophylaxis Management of HIV - Post-Expo...MedicineAndHealthUSA
This document discusses occupational exposure management and post-exposure prophylaxis (PEP) for HIV. It provides an overview of guidelines and recommendations for PEP, including initiating treatment as soon as possible after exposure, preferably within 1-36 hours. PEP has been shown to reduce risk of HIV transmission by 81% based on a CDC case-control study. Proper protocols and rapid access to full PEP regimens are important for effective implementation of occupational PEP programs.
The document discusses biomedical HIV prevention modalities currently being researched and tested, including microbicides, pre-exposure prophylaxis (PrEP), circumcision, vaccines, and others. It outlines the research processes involved and challenges, and notes that within the next two years results will be seen from several PrEP and microbicide studies that could impact availability and discussions around access and use. Key concerns discussed include understanding and communicating "partial efficacy", monitoring and preventing drug resistance, and ensuring equity in access.
Современное лечение ВИЧ : АРТ как профилактика.Contemporary Management of HIV...hivlifeinfo
Contemporary Management of HIV. Antiretroviral Therapy As Prevention.2016
In this downloadable slideset, Kenneth Mayer, MD, and Program Director Eric S. Daar, MD, review key data and optimal approaches for pre- and post-exposure prophylaxis in patients at risk for HIV infection.
Format: Microsoft PowerPoint (.ppt)
File size: 2.13 MB
Современное лечение ВИЧ: лечение ВИЧ у женщин.2017/Contemporary Management of...hivlifeinfo
In this downloadable slideset, Kathleen E. Squires, MD, and Program Director Joseph J. Eron, Jr., MD, review key data and optimal strategies in caring for HIV-infected women, including ART safety and efficacy in women, reproductive health management, ART and pregnancy, and preventing HIV infection in women.
Format: Microsoft PowerPoint (.ppt)
File size: 1.59 MB
Date posted: 4/25/2017
Tratamiento antirretroviral combinado en dosis fija en un comprimido (STR) con Inhibidores de la proteasa (IP) y tenofovir alafenamida (TAF) para pacientes con diagnóstico de VIH. Pacientes VIH NAIVE, inicio de tratamiento precoz y simplificación (Swich). Postgrado. Dirigido a las siguientes especialidades: Clínica médica, infectología, atención primaria con experencia en la asistencia de pacientes con diagnóstico de VIH.
Dr. Kathleen Brady's presentation on PrEP (pre-exposure prophylaxis) for HIV, as given to the Philadelphia HIV Prevention Planning Group (HPG) on March 25, 2015.
Beta Lactam: To Extend or not to Extend: That is the Question!munaoqal
The document discusses evidence for extended infusion of beta-lactam antibiotics. It provides pharmacokinetic and pharmacodynamic evidence showing extended infusion improves time above the minimum inhibitory concentration compared to intermittent infusion. Several meta-analyses and clinical studies summarized show extended infusion is associated with improved clinical outcomes like mortality, clinical cure rates and length of hospital stay. Extended infusion may also reduce costs by allowing for lower total daily doses. The evidence consistently supports extended infusion as a safe, effective and potentially superior strategy to intermittent infusion, especially in critically ill patients.
Dr. Michael Davies presents the latest information on targeted melanoma therapies at the MRF's Patient Symposium at MD Anderson Cancer Center on January 31, 2015.
Similar to Prophylaxis and HIV Prevention by Dr. Ken Mayer (20)
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
2. HIV Prevention: Current Targets Condom and HIV testing promotion Individual interventions Couples interventions Community-based interventions Structural interventions Barrier protection Blood screening IDU harm reduction Antiretroviral therapy (PMTCT, treat infected partners) STI treatment Barrier protection Infection control Circumcision PEP, PrEP Topical microbicides Vaccines STI treatment Alter Behavior Decrease Host Susceptibility Decrease Source of Infection
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4. Per-Act Risk for HIV Acquisition 01/05 Exposure Route Risk per 10,000 exposures Blood transfusion 9,000 Needle-sharing injection drug use 67 Receptive anal intercourse 50 Percutaneous needle stick 30 Receptive penile-vaginal intercourse 10 Insertive anal intercourse 6.5 Insertive penile-vaginal intercourse 10 Receptive oral intercourse 1 Insertive oral intercourse 0.5
5. Not all ART may be equal for Prevention: Ratio of Genital:Blood Plasma Levels Nicol MR, et al. Clin Pharmacol Ther. 2010;88:598-609. Women Men Genital Tract:Blood Plasma AUC Ratio of 1.0: genital tract AUC=blood plasma AUC. Genital tract exposure within 2 and 1 hour of dosing for women and men, respectively. NRTI NNRTI PI Entry Inhibitor INSTI 6.0 5.0 4.0 3.0 2.0 1.0 0.5 0 ddI ABC d4T APV RTV ATV LPV SQV Genital Tract:Blood Plasma AUC NRTI NNRTI PI Entry Inhibitor INSTI 6.0 5.0 4.0 3.0 2.0 1.0 0.5 0 d4T APV, ATV,LPV DRV,SQV, RTV TDF ZDV FTC 3TC ETV NVP EFV DRV IDV MRV RAL TDF ZDV 3TC FTC NVP EFV IDV MRV RAL ABC
30. Combination Antiretroviral Prevention Modified from www.hptn.org. Decrease in HIV Transmission Maintain Viral Suppression Treat Enroll in Care Address concomitant concerns, e.g. depression, substance use, relationship dynamics HIV Negative Test Interventions to Increase Testing Positive Prevention Linkage To Care Adherence to ART ART Initiation Risk Assessment PrEP, Adherence Counseling HIV Positive
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Editor's Notes
Slide: HIV Prevention: Current Targets HIV continues to spread rapidly in developing countries and remain at unacceptable levels in developed countries. These trends are unlikely to change because: 1 Current HIV-prevention strategies are only partially effective and underused. Preventative vaccine remains years away. Current HIV treatment strategies can not eradicate HIV infection. Increasing attention has therefore focused on whether available antiretroviral drugs could be used to slow the epidemic. However, the initiation of HAART for prevention can manifest differently in diverse social settings, raising concerns over increased sexual risk taking behavior, viral resistance, toxicities, costs, and risk compensation, to name a few. 1 Abbreviations: IDU: injection drug user; PMTCT: prevent mother-to-child-transmission; STI: sexually transmitted disease; PEP: postexposure prophylaxis; PrEP: pre-exposure prophylaxis. Reference Mayer KM, Nenkatesh KK. Antiretroviral therapy as HIV prevention: status and prospects. Am J Public Health. 2010;100:1867-1876.
Slide: Why Antiretroviral Agents for HIV Prevention? The prophylactic use of antimicrobial agents have been the foundation of prevention against many infections. Data from animal studies have shown that multiple antiretroviral agents decrease HIV transmission pre- or postexposure prophylaxis (PEP). In humans, the use of antiretroviral therapy is standard of care for the prevention of mother-to-child transmission of HIV as well as for occupational postexposure prophylaxis after percutaneous exposure. 1-4 The use of antiretroviral agents for HIV prevention has gained consideration because of the improved tolerability of newer agents, the potential for lower-cost generic alternatives, and the challenges encountered with other methods (eg, vaccine). 3,4 References Connor EM, Sperling RS, Gelber R, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med . 1994;331:1173-1180. Cardo DM, Culver DH, Ciesielski CA, et al. A case-control study of HIV seroconversion in health care workers after percutaneous exposure. Centers for Disease Control and Prevention Needlestick Surveillance Group. N Engl J Med . 1997;337:1485-1490. Grant RM. Antiretroviral agents used by HIV-uninfected persons for prevention: pre- and postexposure prophylaxis. Clin Infect Dis . 2010;50(suppl 3):S96-S101. Venkatesh KK, Lurie MN, Mayer KH. How HIV treatment could result in effective prevention. Future Virol. 2010;5:405-415.
Estimates of per-act risk of acquisition of HIV are approximate and vary widely depending on the viral load of the source contact, the presence of sexually transmitted diseases, and other factors.
Slide: Antiretroviral Systemic PrEP: Ratio of Genital:Blood Plasma Levels Concentrations of the drugs in blood plasma do not always correlate with those in the genital tract and rectum, and accumulation ratios vary between and within therapeutic classes. The mechanisms that underlie these differences have yet to be fully elucidated. 1 This slide shows the differences in genital-to-plasma ratios for antiretroviral levels in men and women. 1 Reference Nicol MR, Kashuba AD. Pharmacologic opportunities for HIV prevention. Clin Pharmacol Ther. 2010;88:598-609.
Slide: What If PrEP Works? There are a number of issues that need to be addressed if PrEP is shown to be efficacious and safe. These issues include: Block other steps in the HIV life cycle? Develop drugs just for prevention. New co-formulations (generic PrEP?). Topical versus oral (VOICE and beyond). Optimal drug delivery system. How best to dose. Interaction with other prevention modalities. Optimal utilization and effectiveness may require multiple modalities.
Slide: What If PrEP Works? There are a number of issues that need to be addressed if PrEP is shown to be efficacious and safe. These issues include: Block other steps in the HIV life cycle? Develop drugs just for prevention. New co-formulations (generic PrEP?). Topical versus oral (VOICE and beyond). Optimal drug delivery system. How best to dose. Interaction with other prevention modalities. Optimal utilization and effectiveness may require multiple modalities.
Slide: What If PrEP Works? There are a number of issues that need to be addressed if PrEP is shown to be efficacious and safe. These issues include: Block other steps in the HIV life cycle? Develop drugs just for prevention. New co-formulations (generic PrEP?). Topical versus oral (VOICE and beyond). Optimal drug delivery system. How best to dose. Interaction with other prevention modalities. Optimal utilization and effectiveness may require multiple modalities.
Both the study article and the supplemental material are available free of charge that the NEJM website until approximately December 30, when the manuscript will be published in the print edition of the Journal. The supplemental material contains important graphs and tables and additional discussion about the findings.
All iPrEx participants were followed very closely throughout the study to protect their safety and to monitor for any possible adverse effects from the PrEP regimen. The FTC/TDF combination was chosen for this study because both drugs stay active in the body for long periods, allowing for once daily dosing; both drugs are approved for the treatment of HIV and have been shown to be safe; and both drugs have demonstrated protection against HIV in animal studies of PrEP, with the two drugs having shown higher levels of protection together. Both drugs are also available in patented and generic formulations.
All iPrEx study participants received the same comprehensive package or prevention services designed to reduce their risk of HIV infection throughout the trial, including HIV testing, intensive safer sex counseling, condoms and treatment and care for sexually transmitted infections. Half of study participants also received the PrEP pill, while the other half received a placebo.
The majority of iPrEx study participants came from the Americas. The iPrEx study began in Peru and Ecuador, and expanded to include participants in Brazil, the United States, South Africa and Thailand.
Efficacy was evident in all of the analyses. The intention to treat analysis included all enrolled participants. The modified intention to treat analysis included all enrolled participants except for the 10 who were subsequently found to be viral RNA positive at the enrollment visit. The as treated analysis (50%) considered visits when pill use was recorded on 50% or more of days, based on pill counts, self-report, and pill dispensation records. The as treated analysis (90%) considered visits when pill use was recorded on 90% of days, as above. The efficacy was higher among those reporting unprotected receptive anal intercourse at enrollment (URAI). URAI was the strongest risk factor for HIV acquisition in this study, and other studies of MSM.
A nested case control study was performed that included drug level analysis of blood specimens of 34 of the 36 seroconverters on the FTC/TDF arm of the study, and a set of seronegative controls also from the active arm. One timepoint per person was analyzed. In the HIV infected cases, the timepoint was the first laboratory evidence of HIV infection, whether that evidence was antibody or RNA. The seronegative controls were selected from the same sites at comparable timepoints. Emtricitabine and Tenofovir was measured in blood plasma, and emtricitabine-tri-phosphate and tenofovir-di-phosphate were measured in peripheral blood mononuclear cells. All measurements were by tandem mass spectroscopy. No drug was detected in a sample of placebo arm participants. Drug detection was more than 95% concordant between the different measurements. Overall, one or more drugs were detected in the active arm of the study in 51% of the seronegatives and 9% of the HIV cases. This contrasts with reported adherence which was more than 90% on average. Over-reporting of adherence is common in treatment and prevention trials.
There were differences in mild side effects between the arms. TDF is known to decrease renal function a small amount in HIV infected persons. We also observed a trend toward more creatinine elevations in the active arm of the study. Most the creatinine elevations resolved without stopping study drug and many remained within the normal range (they were elevations only in that they increased more than 50% from the participant’s baseline). Only 5 (0.4%) of the active arm had creatinine elevations that persisted until the following visit; all resolved after stopping FTC/TDF. Four of these were rechallenged without recurrence in the creatinine elevation. Headache, nausea, and unintentional weight loss of 5% was reported more frequently in the active arm, typically in the first few weeks of pill use. The proportion affected was less than 1 in 20 participants. There were no differences between groups in diarrhea or depression and a large number of other adverse events and lab markers.
Nausea was also assessed by medical history at all visits. Nausea was reported in 1 in 10 (9%) of the active arm participants and 5% of placebo users, and decreased to comparable levels at subsequent visits. This is consistent with start up symptoms that occur in some persons starting antiviral therapy. People’s long term adherence to therapy, and possibly PREP, could be enhanced if they receive supportive counseling for side effects in the first 4 weeks of pill use.
Slide: Topical TDF or FTC/TDF Gel: Complete Protection From SHIV Exposure Parikh and colleagues evaluated tenofovir with or without emtricitabine as preexposure prophylaxis by using a twice-weekly repeat challenge macaque model and showed that a preexposure vaginal application of gel with 1% tenofovir DF alone or in combination with 5% emtricitabine could fully protected macaques from a total of 20 exposures to SHIV. 1 Reference Parikh UM, Dobard C, Sharma S, et al. Complete protection from repeated vaginal simian-human immunodeficiency virus exposures in macaques by a topical gel containing tenofovir alone or with emtricitabine. J Virol . 2009;83:10358-10365.
Slide: CAPRISA 004 Results: HIV Incidence HIV incidence in the tenofovir gel arm was 5.6 per 100 women-years (person time of study observation) (38 out of 680.6 women-years) compared with 9.1 per 100 women-years (60 out of 660.7 women-years) in the placebo gel arm ( P =0.017). 1 In high adherers (gel adherence >80%), HIV incidence was 54% lower ( P =0.025) in the tenofovir gel arm. In intermediate adherers (gel adherence 50% to 80%) and low adherers (gel adherence < 50%), the HIV incidence reduction was 38% and 28%, respectively. Tenofovir gel reduced HIV acquisition by an estimated 39% overall, and by 54% in women with high gel adherence. 1 Reference Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science . 2010;329:1168-1174.
Slide: Intermittent PrEP in Macaques With Oral FTC/TDF Garcia-Lerma and colleagues demonstrated maximum protection from 14 weekly SHIV exposures when an oral pre-exposure dose 22 hours before exposure is followed by a postexposure dose at 2 hours after the exposure (hazard ratio 16.7). This protection decreases when the pre-exposure dose is administered as early as 3 and 7 days before infection (hazard ratio 15.4 and 9.3, respectively) or if the postexposure dose is delayed by 22 hours after the infection (hazard ratio 4.1). 1 Reference García-Lerma JG, Paxton L, Kilmarx PH, et al. Oral pre-exposure prophylaxis for HIV prevention. Trends Pharmacol Sci . 2010;31:74-81.
Slide: New Antiretroviral Topical Microbicides This slide provides an overview of microbicides in development and their clinical development status.
Slide: What If PrEP Works? There are a number of issues that need to be addressed if PrEP is shown to be efficacious and safe. These issues include: Block other steps in the HIV life cycle? Develop drugs just for prevention. New co-formulations (generic PrEP?). Topical versus oral (VOICE and beyond). Optimal drug delivery system. How best to dose. Interaction with other prevention modalities. Optimal utilization and effectiveness may require multiple modalities.
Slide: HPTN 065: Testing, Linkage to Care, Treatment, Plus Lots More… HPTN 065 is a study to assess the feasibility of a community-level test, link to care, plus treat strategy (TLC-Plus) in the United States. The primary outcomes of the TLC-Plus package of interventions will be determined through measurement of change over the duration of the study in key parameters in two intervention communities. Observations in the four non-intervention control communities will help assess the influence of current trends in HIV testing and care expansion in the United States. 1 TLC-Plus is uses innovative approaches, including: 1 A community focus. Multi-component strategies that include behavioral and biomedical interventions. The use of routinely reported HIV surveillance data to determine key outcomes. A partnership with local Departments of Health and the Centers for Disease Control and Prevention. This study will serve as a proof-of-concept formative study. It will provide key information that could guide the design and anticipate the costs of a future large randomized, community-level clinical trial of full implementation of a test-and-treat strategy in the United States. Findings from this study could also inform test-and-treat efforts in other developed countries with epidemics similar to that in the United States. 1 Reference Available at: www.hptn.org.
Slide: What If PrEP Works? There are a number of issues that need to be addressed if PrEP is shown to be efficacious and safe. These issues include: Block other steps in the HIV life cycle? Develop drugs just for prevention. New co-formulations (generic PrEP?). Topical versus oral (VOICE and beyond). Optimal drug delivery system. How best to dose. Interaction with other prevention modalities. Optimal utilization and effectiveness may require multiple modalities.