Holtz TH и др. «HPTN 067/ADAPT study: a comparison of daily and non-daily pre-exposure prophylaxis dosing in Thai men who have sex with men, Bangkok, Thailand» 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, 2015. MOAC0306LB.
HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure pro...Илья Антипин
Mannheimer S. и др. «HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure prophylaxis (PrEP) dosing for HIV prevention in men who have sex with men and transgender women in New York city» 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, 2015. MOAC0305LB.
Pharmacology for Physiotherapy Book By Padmaja Udaykumar Second Edition.Khalid Ghaznavi
Pharmacology for Physiotherapy Book
By Padmaja Udaykumar Second Edition.
This consists of a complete book version. I hope this will be helpful for you.
HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure pro...Илья Антипин
Mannheimer S. и др. «HPTN 067/ADAPT study: a comparison of daily and intermittent pre-exposure prophylaxis (PrEP) dosing for HIV prevention in men who have sex with men and transgender women in New York city» 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, 2015. MOAC0305LB.
Pharmacology for Physiotherapy Book By Padmaja Udaykumar Second Edition.Khalid Ghaznavi
Pharmacology for Physiotherapy Book
By Padmaja Udaykumar Second Edition.
This consists of a complete book version. I hope this will be helpful for you.
CCTG 595: A Multicenter, Randomized Study of Text messaging to improve Adherence to PrEP In Risky MSM (TAPIR)
Sheldon Morris MD MPH and David Moore PhD
August 26th, 2016
UCSD HIV & Global Health Rounds
Ich (s5 r2) The International Council for Harmonisationof Technical Requireme...AMIT KUMAR
GUIDLINES FOR REPRODUCTIVE TOXICOLOGY,Strategies for reproductive toxicity assessment,The International Council for Harmonisation,of Technical Requirements for Pharmaceuticals for Human Use
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
iCAAD London 2019 - Mel Pohl - CHRONIC PAIN AND ADDICTION: HOW WE MISSED THE...iCAADEvents
Chronic Pain occurs as a complicated web of emotions and physical symptoms. The most common way to treat pain is to use opioid medications, which actually complicate the course of chronic pain.
iCAAD London 2019 - Antonio Metastasio - PERSONALISED MEDICINE IN THE TREATM...iCAADEvents
Personalised medicine is considered the next frontier of health care. The role of genetic testing in psychiatry and in addictions medicine, however, has been recently critically reviewed. Are genetic tests helpful in assessing and managing these conditions?
HPTN 067/ADAPT methods and results from women in Cape TownИлья Антипин
Grant R. и др. «HPTN 067/ADAPT methods and results from women in Cape Town» 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, 2015. MOSY0103.
Project Ready, Set, PrEP! training on PrEP for HIV Prevention - UPDATED NOV 17Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on November 17. Other partners on this training included University of Chicago. These slides comprise a 3.5 hour training designed for people in the HIV workforce that AFC and partners conduct at various times in the year. They are continually updated.
Personalised medicines -pharmacogentics and pharmacogenomicsAlakesh Bharali
This seminar basically introduces and explains the learner about what is personalised medicines, what is the need for it, how personalised medicines work. For this, the concept of pharmacogenetics and pharmacogenomics are considered. After going through the presentation, the learner will be able to understand about the concept of pharmacogentics and pharmacogenomics. Certain examples of personalised medicines are included in this seminar.Although personalised medicines are specific and helpful, ins spite of having lots of advantages , it also have some disadvantages which are also specified in this seminar.Although , we speak about personalised medicines, we never saw personalised medicines in our local market. So here is an approach given that , when will we see personalised medicines at the local pharmacy. Again, certain marketed products are also listed in the seminar.Also, the future of personalised medicines is depeicted in the seminar. How medicines will be in a an around 2050 is shown in the seminar. After going through the seminar, the learner would be able to understand about personalised medicines and all its aspects in detail.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
CCTG 595: A Multicenter, Randomized Study of Text messaging to improve Adherence to PrEP In Risky MSM (TAPIR)
Sheldon Morris MD MPH and David Moore PhD
August 26th, 2016
UCSD HIV & Global Health Rounds
Ich (s5 r2) The International Council for Harmonisationof Technical Requireme...AMIT KUMAR
GUIDLINES FOR REPRODUCTIVE TOXICOLOGY,Strategies for reproductive toxicity assessment,The International Council for Harmonisation,of Technical Requirements for Pharmaceuticals for Human Use
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology. I highlight some bioinformatic roles in the drug discovery process, and discuss the use of semantic web technologies for data integration and knowledge discovery..
iCAAD London 2019 - Mel Pohl - CHRONIC PAIN AND ADDICTION: HOW WE MISSED THE...iCAADEvents
Chronic Pain occurs as a complicated web of emotions and physical symptoms. The most common way to treat pain is to use opioid medications, which actually complicate the course of chronic pain.
iCAAD London 2019 - Antonio Metastasio - PERSONALISED MEDICINE IN THE TREATM...iCAADEvents
Personalised medicine is considered the next frontier of health care. The role of genetic testing in psychiatry and in addictions medicine, however, has been recently critically reviewed. Are genetic tests helpful in assessing and managing these conditions?
HPTN 067/ADAPT methods and results from women in Cape TownИлья Антипин
Grant R. и др. «HPTN 067/ADAPT methods and results from women in Cape Town» 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Vancouver, 2015. MOSY0103.
Project Ready, Set, PrEP! training on PrEP for HIV Prevention - UPDATED NOV 17Jim Pickett
This training on PrEP for HIV prevention was conducted by AIDS Foundation of Chicago (AFC) in collaboration with the Chicago Department of Public Health on November 17. Other partners on this training included University of Chicago. These slides comprise a 3.5 hour training designed for people in the HIV workforce that AFC and partners conduct at various times in the year. They are continually updated.
Personalised medicines -pharmacogentics and pharmacogenomicsAlakesh Bharali
This seminar basically introduces and explains the learner about what is personalised medicines, what is the need for it, how personalised medicines work. For this, the concept of pharmacogenetics and pharmacogenomics are considered. After going through the presentation, the learner will be able to understand about the concept of pharmacogentics and pharmacogenomics. Certain examples of personalised medicines are included in this seminar.Although personalised medicines are specific and helpful, ins spite of having lots of advantages , it also have some disadvantages which are also specified in this seminar.Although , we speak about personalised medicines, we never saw personalised medicines in our local market. So here is an approach given that , when will we see personalised medicines at the local pharmacy. Again, certain marketed products are also listed in the seminar.Also, the future of personalised medicines is depeicted in the seminar. How medicines will be in a an around 2050 is shown in the seminar. After going through the seminar, the learner would be able to understand about personalised medicines and all its aspects in detail.
bevacizumab chemotherapy treatment of metastastic colorectal cancer metasta...Мандухай Г.
Bevacizumab is one of the chemotherapy for metastatic colorectal cancer. It is effective with Irinotecan, fluorouracil,, and Leucovorin for metastatic colorectal cancer.
High efficacy of grazoprevir/elbasvir in HCV genotype 1, 4, and 6-infected pa...Илья Антипин
Rockstroh J. и др. «High efficacy of grazoprevir/elbasvir in HCV genotype 1, 4, and 6-infected patients with HIV co-infection: the phase 3 C-EDGE co-infection study» 8th IAS Conference on HIV Pathogenesis, Treatment, and Prevention, Vancouver, 2015. TUAB0206.
Raltegravir for prevention of mother-to-child transmission of HIVИлья Антипин
Trahan M.J. (докладчик Kakkar F.) «Raltegravir for prevention of mother-to-child transmission of HIV» 8th IAS Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2015), Vancouver, 2015. TUAB0105.
High SVR rates in HCV/HIV-1 co-infected patients regardless of baseline chara...Илья Антипин
Wyles D и др. «High SVR rates in HCV/HIV-1 co-infected patients regardless of baseline characteristics» 8th IAS Conference on HIV Pathogenesis, Treatment, and Prevention, Vancouver, 2015. TUAB0203.
Antiretroviral intensification to prevent intrapartum HIV transmission in lat...Илья Антипин
Lallemant M. и др. «Antiretroviral intensification to prevent intrapartum HIV transmission in late comers» 8th IAS Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2015), Vancouver, 2015. MOAC0204.
Similar to HPTN 067/ADAPT study: a comparison of daily and non-daily pre-exposure prophylaxis dosing in Thai men who have sex with men, Bangkok, Thailand
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.
HIV Prevention: Combating PrEP Implementation ChallengesCHC Connecticut
Expert faculty present case-based scenarios illustrating common challenges to integrating HIV PrEP in primary care. As part of improving clinical workforce development, this session will delve into a variety of specific PrEP implementation challenges. Participants will leave with strategies to overcome these obstacles to establish or strengthen their PrEP program.
Panelists:
• Marwan Haddad, MD, MPH, AAHIVS, Medical Director, Center for Key Populations, Community Health Center, Inc.,
• Jeannie McIntosh, APRN, FNP-C, AAHIVS, Family Nurse Practitioner, Center for Key Populations, Community Health Center, Inc.
An overview of knowledge and use of PrEP among gay men in Australia.
This presentation was given by Dean Murphy, AFAO HIV Education Officer, at the AFAO National HIV Forum, 17 October 2014.
Jill Blumenthal, MD
Assistant Professor of Medicine
Division of Infectious Diseases and Global Public Health
Department of Medicine
University of California, San Diego
Lizzy Schmidt, Director of the Woman's Program at Philadelphia FIGHT's Jonathan Lax Center, presented on HIV Treatment and PrEP at the June 2015 Ryan White Part A Planning Council meeting.
Project RSP! Training on PrEP for HIV PreventionJim Pickett
June 11 - UPDATED training on PrEP for HIV prevention from Chicago's Project Ready, Set, PrEP! (RSP!). Visit the Project RSP!'s My PrEP Experience blog at www.myprepexperience.blogspot.com for more informational resources, including the personal stories of individuals who have chosen to use PrEP.
Project RSP Training on PrEP - July 31, 2015Jim Pickett
This PrEP training - a collaboration between AIDS Foundation of Chicago and the Chicago Department of Public Health - was provided to members of Chicago's HIV workforce on Friday, July 31, 2015.
Project RSP Training on PrEP - November 13, 2015Jim Pickett
This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, November 13, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and two PrEP consumers - Gabe Bahena and Curtis Lewis.
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
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
Project RSP Training on PrEP - September 11, 2015Jim Pickett
This training was conducted by AIDS Foundation of Chicago for members of Chicago's HIV workforce - in partnership with the Chicago Department of Public Health. It took place on Friday, September 11, 2015. Presenters included the CORE Center's Dr. Sybil Hosek, Jim Pickett of AFC, and Gabe Bahena, a PrEP consumer. .
Similar to HPTN 067/ADAPT study: a comparison of daily and non-daily pre-exposure prophylaxis dosing in Thai men who have sex with men, Bangkok, Thailand (20)
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
TOP AND BEST GLUTE BUILDER A 606 | Fitking FitnessFitking Fitness
"Feature:
• Intelligent Ergonomically Design Glute Builder Is A Must Have For Those Looking To Target Their Gluteal Muscles And Hamstrings With Precision.
• The Ability To Adjust The Starting Position, This Machine Allows For A More Targeted Workout That Is Tailored To Your Specific Needs.
• Spacious And Supportive Cushioned Seat Provide Added Comfort And Stability During Your Workout."
Get more information visit on:- www.fitking.in
Our mail I.D:-care@fitking.in, fitking.in@gmail.com
Call us at :- 9958880790, 9870336406, 8800695917
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
HPTN 067/ADAPT study: a comparison of daily and non-daily pre-exposure prophylaxis dosing in Thai men who have sex with men, Bangkok, Thailand
1. A Comparison of Daily and Non-daily
Pre-exposure Prophylaxis Dosing in Thai
Men Who Have Sex With Men, Bangkok
HPTN 067 / ADAPT Study
Timothy H. Holtz, Anupong Chitwarakorn, Marcel E. Curlin,
James Hughes, K. Rivet Amico, Craig Hendrix, Bonnie J.
Dye, Peter L. Anderson, Maoji Li, Vanessa Elharrar, Susan H.
Eshleman, Michael Stirratt, Robert M. Grant and the
Bangkok HPTN 067/ADAPT Study Team
July 20, 2015
2. 249
screened
193
enrolled
56 not enrolled*
HIV + rapid 11/19.6%
Abnormal ALT/AST 13/23.2%
Abnormal Ser Cr 7/12.5%
Lab abnormality 6/10.7%
HbV no immune 11/19.6%
Other medical/mental 2/3.6%
Not enrolled within window 5/8.9%
Other 4/7.1%
*not mutually exclusive
178
randomized
15 not randomized
HIV + false 2/13.3%
HIV + in DOT 2/13.3%
Product hold 1/6.7%
Withdrew 1/6.7%
Lost contact 2/13.3%
Other 7/46.7%
60
Daily usage
59
Time-driven
usage
59
Event-driven
usage
Self-Administered Phase
DOT
Phase
3. Participant Demographics: Bangkok
Variable % (N=178)
Median age (years, IQR)
Age ranges
18-20
21-25
26-30
31-35
36-40
>40
31 (27,34)
1%
21%
28%
30%
14%
6%
Gender identity
Male
TGW
99%
1%
Race
Asian 100%
Never married 97%
Education
Completed college
In college, not completed
83%
6%
Unemployed
Student
11%
9%
4. Coverage (PrEP Before and After Sex):
Daily vs. Time-Driven vs. Event-Driven
85%
11%
1% 3%
84%
12%
3% 1%
74%
19%
5% 3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
% complete
coverage
% only
pre-sex dose
% only
post-sex dose
no
coverage
Daily
Time-driven
Event-driven
D/T p = 0.79, D/E p = 0.02, T/E p = 0.04, global p = 0.19
5. FTC/TDF Pills by Arm
9420
4121
1928
8285
3713
2157
Daily Time-driven Event-driven
Numberoftablets
Required tablets
Tablets reported taken
Required tablets: p < 0.001 for all comparisons (D/T, D/E, and T/E)
Tablets actually taken: p < 0.001 for all comparisons (D/T, D/E, and T/E)
6. Adherence (Total pills taken/Total pills required):
Daily vs. Time-Driven vs. Event-Driven
D/T p < 0.42, D/E p < 0.001, T/E p < 0.001, global p < 0.001
7. Neuro and GI Symptoms / Side Effects
Side Effect reported Daily Time Event p value
% PPTs who experienced
any neurologic side effects
48% 46% 54% 0.64
% PPTs who experienced
any GI side effects
45% 34% 41% 0.46
9. HIV Incidence
• 2 seroconversions during the 6-week pre-
randomization weekly DOT study phase
– Both occurred at week 4
– Both had low levels of FTC detected and no
detectable TVF in plasma
– Both had low detectable levels of both FTC and
TVF in PBMC
– 2 of 193 participants over 22.9 person-years;
incidence 8.7% (1.1%–31.5%) during DOT phase
– 0 of 178 participants over 94.8 person-years;
incidence 0.0% (0.0%–3.9%) during self-
administered (SA) phase
10. Tenofovir diphosphate in PBMCs:
Proportion achieving detectable concentration
Time period Study
Regimen
Daily (D)
Study
Regimen
Time (T)
Study
Regimen
Event (E)
Week 10
(with sex in the past 7
days)
100%
(n=31/31)
97%
(n=28/29)
93%
(n=28/30)
Week 30
(with sex in the past 7
days)
91%
(N=21/23)
95%
(N=18/19)
86%
(N=12/14)
Detectable >9.1 fmol/million PBMC
D/T p = 0.90, D/T p = 0.28, T/E p = 0.35, global p = 0.48
11. Median tenofovir diphosphate drug
concentration in PBMCs
Time period Study
Regimen
Daily (D)
Study
Regimen
Time (T)
Study
Regimen
Event (E)
Week 10
(with sex in past 7 days)
(fmol/million cells)
81.1
(N=31)
35.3
(N=29)
26.4
(N=30)
Week 30
(with sex in past 7 days)
(fmol/million cells)
102.0
(N=23)
46.8
(N=19)
32.9
(N=14)
D/T p < 0.001, D/T p < 0.001, T/E p = 0.0495, global p < 0.001
12. Qualitative Component Methods
• 38 HPTN 067/ADAPT MSM participants
joined a qualitative evaluation: 32
participants joined in 6 focus-group
discussions (FGDs) and 6 attended key-
informant interviews (KIIs).
• Grounded theory and content analysis
were used to analyze the data.
13. Patterns of sex
• Have sex frequently
• Prefer not to plan for sex
• Do not have control over planning for sex with
sexual partners
• Self-perceived of having high HIV risk
Pros
• Easily taken, can take with daily vitamins
• Able to set tablet-taking time regardless of sex
• No need to carry tablets
• No need to disclose about PrEP use
Cons
• Concerns about long-term impacts and side effects
• Fear of being seen as being HIV-infected
• Difficult to use if sex were infrequent
• Difficulty to take daily for long period of time
• Routine change
• Tablet fatigue
• Affordability
Daily
regimen
14. Patterns of sex
• Have infrequent sex event
• Inability to plan sex / have no control over planning for
sex with sexual partners
Pros
• Fewer doses (less concerns about side effects)
• Able to choose the day to take tablets (2 doses/week)
• No need to plan for sex (keep few tablets in pocket for
post-sex dose after unexpected sex event)
Cons
• Difficulty in linking routine activity with 2 tablet-taking
days
• Complicated regimen (No more than 1 dose in a 2 hour
window)
• Need to carry few tablets at all times
• Difficult to hide tablets from sexual partners
• Planning for sex made sex no longer enjoyable
Time-
driven
regimen
15. Patterns of sex
• Have infrequent sex event
• Ability of sex planning / have control over
planning for sex with sexual partners
Pros
• Fewer doses (less concerns about side effects)
Cons
• Need sex planning
• Need to carry tablets at all times (pre/post-sex
dose)
• Difficult to hide tablets from sexual partners
• Regimen confusion (need to count by hours)
• Complicated regimen (No more than 1 dose in a
2 hour window)
Event-
driven
regimen
16. • Compared with the daily regimen, the time-driven
dosing regimens offered comparably high PrEP
coverage for sex acts with
– slightly less adherence
– fewer tablets required
• Among Thai MSM, adherence and drug
concentrations were highest in the daily arm
• TFV drug detection in PBMCs was high (>85%) in
all 3 arms at weeks 10 and 30 in this population
in Bangkok
– Indicates feasibility of non-daily regimens in this
population
Summary of Study Results
17. • Daily dose was the easiest regimen without
the ability to plan for sex, but there were
concerns about long-term impact and
affordability
• Non-daily PrEP would be another choice
for those MSM who have infrequent sex
events, capacity to plan for sex, and ability
to take a post-sex dose
Summary cont’d – Qualitative
Poster presentation # WELBPE23
18. • Among those with few exposures, non-daily
dosing of PrEP could result in fewer tablets
required to achieve comparable coverage
– Importantly: coverage as defined in this study (1 or
more pills before & after sex) is not yet known to be
effective
– If proven effective in future research, non-daily
regimens could provide an alternative for those who
can adhere
• Study results offer additional support for
current CDC guidelines for daily dosing
Conclusion
19. The HIV Prevention Trials Network is sponsored by the
National Institute of Allergy and Infectious Diseases,
the National Institute of Mental Health, and the National
Institute on Drug Abuse, all components of the
U.S. National Institutes of Health.
ACKNOWLEDGEMENTS
The HPTN 067 Bangkok Study Team acknowledges:
Our HPTN 067 participants
Study staff at Silom Community Clinic @TropMed
DAIDS and NIMH
Thailand Ministry of Public Health
Epidemiology Branch, Division of HIV/AIDS Prevention, CDC
MSM Community Advisory Board
FHI 360
SCHARP
HPTN Laboratory Center
22. Number of Sex Acts Over Study
Follow-up by Study Arm, Weekly Interview
23. Average number of sex acts per week (excluding oral)
reported at weekly interviews by study arm
24. • Over the span of
each previous 3
months, MSM in
our study had
sex on average
about once per
week (13 at
week 6, and 12
at week 30)
• Rarely if ever
without a
condom
Period D T E
Number of times had sex in
past 3 months at week 6
Mean
Median
Without a condom
13
10
0
17
10
0
10
6
0
Number of times had sex in
past 3 months at week 30
Mean
Median
Without a condom
14
10
0
13
10
0
9
6
0
Kruskall-Wallis p for difference between
three groups at week 30 = 0.023
25. • Over the span
of each
previous 3
months, MSM
had on average
7 different sex
partners
Period D T E
Number of sex partners
in past 3 months at
week 6
Mean
Median
5.9
3
10.8
3
4.5
3
Number of sex partners
in past 3 months at
week 30
Mean
Median
6.2
3
9.3
4
4.5
3
Kruskall-Wallis p for difference between
three groups at week 30 = 0.099
26. Number of Sex Acts over Last 3 Months from CASI vs
Weekly Interview Log
28. A Phase II, Randomized, Open-label,
Pharmacokinetic And Behavioral Study Of The Use
Of Intermittent Oral Emtricitabine/Tenofovir
Disoproxil Fumarate Pre-exposure Prophylaxis
(PrEP)
Alternative
Dosing
to Augment PrEP
Pill
Taking
29. • Oral FTC/TDF PrEP is effective for preventing sexual
HIV infection when used daily
• Concerns about cost and side effects can limit
uptake
• Daily and non-daily regimens have not been
compared directly with respect to prophylactic
coverage for sexual exposure
• Less frequent oral dosing regimens might reduce
side effects and might favorably or unfavorably affect
adherence
• Daily FTC/TDF (Truvada) is currently FDA-approved
in U.S. for pre-exposure prophylaxis (PrEP) for HIV
prevention for populations at risk including men who
have sex with men (MSM)
Introduction
30. • The HPTN 067 ADAPT trial Bangkok site, a phase 2,
randomized, open-label clinical trial of oral
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)
PrEP was conducted among men who have sex with
men (MSM), and transgender women (TGW)
• To assess whether recommending non-daily usage of
oral FTC/TDF PrEP, compared with recommending
daily usage, will be associated with:
• Equivalent coverage of sex events with pre- and post-
exposure dosing
• Lower number of pills needed for coverage and fewer pills
used
• Decreased self-reported symptoms/side effects during 24
weeks of self-administered use
ADAPT Study Primary Objective
31. • Assess safety of PrEP users
• Assess adherence by study arm
• Assess PrEP acceptability by arm
• Evaluate potential influence of PrEP on
sexual risk behavior
• Assess drug levels of tenofovir,
emtricitabine, and their metabolites in
plasma and peripheral blood mononuclear
cells (PBMCs)
ADAPT Study Secondary Objectives
32. Methods: Eligibility
• MSM and TGW were eligible if:
– Male at birth, and
– Reported anal intercourse with another male in the
past 6 months, and
– Reported >1 other HIV risk factor in the past 6
months
– Normal renal function (CrCl > 70 ml/min)
• Exclusion criteria included:
– HIV infection
– Hepatitis B infection
– Symptoms of acute HIV
– Use of nephrotoxic drugs
– Proteinuria or glucosuria or low serum phosphate
– Recent PEP or PrEP use
33. Final
Study
Visit
6 week
DOT
phase
24 weeks
self-administered
dosing
4
weeks
off
drug
RandomizedD
T
E
HPTN 067 Design: Bangkok Site
From 07/12-08/13
Screened: 249
Enrolled: 193
Randomized: 178
Screen/Enrollment ratio
of 1.29
FTC/TDF
Sex coverage
(D) Daily- 1 tab daily
(T) Time driven- 1 tab twice a week plus 1 tab post-sex
(E) Event driven- 1 tab before and 1 tab after sex
No more than 2 dose daily and 7 doses/week
Wk 0 Wk 34
Qualitative:
32 FGD and 6 KII:
Participants,
Staff
MSM & TGW
34. Methods cont’d
• We contacted participants weekly to collect
dates/times of PrEP use (monitored
electronically by the Wisepill™ dispensing
device) and sex events
• Participants filled out a computer-assisted self
interview (CASI) about sexual behavior and
frequency at screening, 6, 10, and 30 weeks
• We collected plasma and PBMCs and
analyzed for tenofovir (TFV) and FTC and their
active metabolites at 10 and 30 weeks
• Participants who acquired HIV infection during
the study discontinued dosing and were
followed until study closure and referred for
post-trial care
35. • Coverage for all arms was defined as >1 pill
taken in the 4 days before and >1 pill taken
in the 24 hours after sexual intercourse
• Adherence was defined as the proportion of
recommended pills taken for each regimen
Methods: Definitions
36. Definition: Covered event
Coverage for all arms:
>1 pill taken in the 4 days before sex
>1 pill taken in the 24 hours after sex
>1 tablet >1 tablet
Editor's Notes
Good afternoon, and nice to see such a large, full room!
My name is Timothy Holtz, a medical officer from the US CDC, and the director of the HIV/STD Research Program at the Thailand Ministry of Public Health – US CDC Collaboration in Bangkok.
I will be presenting results of the HPTN 067 ADAPT study in Bangkok on behalf of my coauthors listed on the title slide.
Given that Sharon my co-investigator has presented the background and methods of this study, I will launch into presenting the results from our site. The only difference in methods is that we tested PBMCs for tenofovir drug levels, which I will discuss in my talk.
In total, we screened 249 men and transgender women for enrollment into 067.
56 persons were not enrolled, most commonly for abnormal liver enzymes.
Among these were 11 persons who tested positive for HIV, reflecting the fact that this was a very high risk population with previously undiagnosed HIV infection
After enrolling 193 MSM and TGW, 15 were not randomized, including 2 persons who seroconverted in the DOT Phase, which I will discuss shortly.
We randomized 178 participants that were evenly distributed between the three arms in the self administered phase of the study.
Among the 178 Thai participants, the median age was 31 years, with a min/max of 20 to 58 and an IQR of 27 and 34.
Thus, the majority of participants were in their early 30s, and nearly 90% had completed or were still in college.
There were 2 TGW participants, with the rest self identifying as male.
Only 11% were unemployed. Participants also included some students.
There were no statistically significant differences between the 3 arms for any of the participant demographic characteristics collected.
As Sharon described, the primary outcomes in this trial were coverage of sex events, number of tablets required and taken, and self-reported side effects.
At our site, PrEP coverages were similar in arms D and T, at 85% and 84%, with no statistically significant difference between these arms [[with a p=0.79]] .
Both coverages were statistically significantly greater than in arm E at 74%, which is still quite high for a non-daily regimen.
Among people randomized to non-daily dosing in all cohorts, the missed dose required for full coverage was usually the post-sex dose.
NOT SPOKEN
The global p value for the 3 arms was 0.19, reflecting the nearly identical coverage of sex events between the daily arm, and the time-driven arm.
As in the other sites, the number of tablets required, shown in blue, was calculated by the number required by each dosing regimen over study follow-up based on the number of reported sex acts, or daily for the D arm. The number of required tablets differed significantly by arms - daily required the most, E required the fewest tablets.
The number of tablets actually taken (shown in red) were significantly lower in the T and E arms compared to daily.
Sometimes participants took more tablets than required. The E arm participants were told to take a tablet if they thought they might have sex.
We computed a single adherence number over follow-up for each participant and used a t-test (effectively) to compare mean adherence between the arms.
Adherence was greater in D (at 85%) compared with T (at 79%) or E (at 65%), although there was no statistically significant difference between arms D and T in adherence.
Compared with D, the number of doses required for full adherence was reduced by 57% in T and by 80% in E (p<0.001)
NOT SPOKEN
The “effect sizes” are the differences in mean adherence between arms. T vs D effect size -0.02; E vs D effect size -0.20; T vs E effect size 0.17
Middle line of box is the median, and edges of the box at the quartiles (so the difference is the IQR).
Lines are standard for boxplot, namely length 1.5*IQR or the furthest data point, whichever is closer.
The global p [< 0.001] refers to differences in adherence among all three arms
These coverage and adherence findings indicate that MANY MSM and TGW can adhere to non-daily PrEP regimens.
The neurologic and GI side effect proportions shown here are EVER occurring during the follow up period. Reported side effects were not uncommon, but were generally mild, and not substantially different in the daily and non-daily arms.
CHANGE:
Self reported GI: (such as nausea, vomiting, diarrhea, gas, bloating and abdominal pain)
Self reported Neuro (such as headache, dizziness, lightheadedness)
Jim – which p value?
Side effects over time demonstrated a clear start up effect.
Over time, all side effect reports gradually diminished with each visit, and most participants did not believe that these side effects were related to the tablets.
These were data from symptom side effect CRFs.
As stated, we had 2 seroconversions during the 6-week pre-randomization weekly DOT study phase. Both occurred at week 4.
Both had low levels of FTC detected and no detectable TVF in plasma. Both had low detectable levels of FTC and TVF in PBMCs.
These 2/193 participants contributed 22.9 person-years; with an incidence of 8.7% (1.1%–31.5%) during DOT phase.
This is comparable to the published incidence data from our MSM cohort and VCT services, and reflects the high risk population we enrolled.
Not Spoken
0 of 178 participants over 94.8 person-years; incidence 0.0% (0.0%–3.9%) during self-administered (SA) phase
Resistant virus?
Among those reporting sex in the past 7 days, the proportion of MSM and TGW in BKK who had detectable drug levels in PBMCs associated with pre- and post sex dosing was equivalent in all three arms.
There was no statistically significant difference between any of the three daily or non-daily arms in our study, at either 10 or 30 weeks. With one exception, in each arm at both time periods, we found over 90% of participants had detectable concentration of tenofovir.
Not Spoken
All participants in daily and time-driven arm were expected to have ≥9.1fmol/106 per regimen recommendations;
Only sexually active in past 7 days event-driven arm participants expected to have ≥9.1fmol/106 per regimen recommendations.
Commensurate with taking 2 tablets per week in any of the arms, which was the minimum if there was full adherence.
When we looked at TFV drug Concentrations in PBMCs at Weeks 10 and 30, participants in the daily arm had the highest concentration of drug. Higher concentrations of drug provide greater forgiveness for occasional missed doses, which is therefore greater in the D arm.
The T and E arms had statistically significantly lower drug levels in PBMCs than did the D arm, and the T arm was significantly higher than E.
NOT SPOKEN
The median value for 4 doses per week is 18.8 (14.5-20.4) fmol/million cells, based on HPTN 066 (Anderson)
Femtomole = 10-15
However, at the rate of one sex event per week on average, the only arm which would reach 4 tablets/week if they were 100% adherent is the daily arm.
We collected qualitative data from 38 THAI participants who joined the ADAPT study IN BANGKOK.
We conducted 6 focus group discussions with 32 participants and 6 key-informant interviews.
Grounded theory and content analysis were used in this study COMPONENT.
We assessed patterns of sex in 3 different arms with pros and cons of each regimen.
For THE D arm, participants reported THAT this regimen worked well if they had: frequent sex eventS, A preference not to plan for sex, having no control over planning for sex with sexual partners, and self-perceived high risk for HIV.
There WERE pros and cons about THE daily regimen, such as being easy-to-take as it can be taken with daily vitamins, no need to plan for sex, no need to carry the TABLETS, and no need to disclose about PrEP use.
But there were concerns about long-term impact and side effects and fears about being seen as an HIV-infected PERSON. Some reported it was difficult to use if they DIDN’T have sex that much. Long-term TABLET-taking, routine change, TABLET fatigue, and affordability were also reported.
Participants in THE T ARM reported THAT this regimen was optimal for: participants with infrequent sex eventS, an inability to plan sex or having no control over planning for sex with sexual partners.
The PROs about this regimen WERE: fewer doses which meant less concerns about side effects; ABILITY TO choose the day to take 2 TABLETS a week, NO need to plan for sex, AND just keepING a few TABLETS with them for THE POST sex dose.
On the other hand, the participants reported difficulty in linking routine activity with 2 TABLET-taking days, confusion about THE regimen because it is quite complicated, the need to carry TABLETS and hide them from others, and they noted that planning for sex made sex no longer enjoyable.
Participants in THE E ARM reported THAT this regimen worked well if participants had: infrequent sex events, AND an ability to plan sex or having control over planning for sex with sexual partners.
The PRO about this regimen was fewer doses REQUIRED.
On the other hand, it WAS difficult for PARTICIPANTS to plan for sex, to carry TABLETS, and to hide them from others. It WAS confusing to count THE TABLET-taking time by the hour, and the regimen WAS complicated or difficult for them to follow.
In summary, large proportions of Thai MSM and TGW took PrEP consistently when given access in a clinical setting, with coverage and adherence highest in the daily arm.
However, at our site, time-driven dosing among MSM and TGW provided coverage of sexual exposures and adherence that was comparable to daily dosing, and spared a considerable number of tablets required.
In our indicator of long term drug coverage, namely PBMCs, tenofovir drug detection was high in all three arms at weeks 10 and 30, indicating the feasibility of non-daily regimens in this population.
Not SPOKEN
And for those of you with Ipergay in mind, and trying to compare the populations, in data that was not shown, I can tell you that non-oral sex events in this population occurred on average of once per week.
Participants reported that the daily dose was the easiest regimen without THE ability of planning for sex, but there WERE concerns about long-term impacts and affordability.
We found that NON-DAILY PrEP would be another choice for those MSM who have infrequent sex events.
Candidates for non-daily dosing could include MSM having relatively infrequent sexual intercourse (less than once a week), capacity for planning for sex, and ability to take a post sex dose.
For more information, please visit OUR poster presentation TOMORROW.
In Conclusion, per CDC Clinical Practice Guidelines, and US Public Health Service Guidelines, daily dosing has proven effective at reducing the risk of HIV infection in multiple clinical trials, and is the FDA-approved regimen. It provides the highest level of protection, the most forgiveness for missed doses, and fosters daily habit formation.
Among those with few exposures, non-daily dosing of PrEP could result in fewer tablets required to achieve comparable coverage. However, one would lose that margin of forgiveness for missed doses [[as we found that drug concentrations were lower]]
We note that coverage as defined in this study is not yet known to be effective.
We have shown non-daily regimens to be feasible, and if proven effective in future research, could provide an alternative for those who are able to adhere.
I would like to dedicate this talk to our former site coordinator for 067 at the Silom Community Clinic, who passed away before the release of these results.
Page 52
Data from weekly interview CRFs,
page 96 Bangkok
Page 109
Screening, 6, 18, 30
There is a significant difference between arms in the number of times they had sex in the three months prior to week 30 as reported in the CASI?
Difference is only between E and T/D
Hypothesis being tested is for a difference in the outcome (number of times had sex in past 3 months) between arms at week 30.
The test used was a Kruskall-Wallis test (nonparametric test)
There is no significant difference between the arms in the number of partners in the three months prior to week 30 as reported in the CASI
Hypothesis being tested is for a difference in the outcome (number of partners in the past 3 months) between arms at week 30.
The test used was a Kruskall-Wallis test (nonparametric test)
Page 92
From page 101
PBMC
Indicator of long term drug coverage
After 6 weeks of DOT [DOT weeks 1,2,3,4, rest 5, randomize at 6] to estimate steady state drug levels, participants were randomly assigned to one of three unblinded PrEP dosing regimens for 24 weeks of self-administered dosing as follows:
Daily (D)
Time Driven: Twice weekly with a post-intercourse boost (T)
Event-driven: Before and after intercourse (E)
Pills were dispensed from an electronic dispensing Wisepill device that recorded each opening
Participants were contacted weekly by phone or in person to review Wisepill data and sex events
The study included a six week lead-in period which included directly observed therapy (DOT) at Enrollment and Weeks 1 through 4, followed by one week without dosing to determine individual steady state pharmacokinetics (PK). This provided the opportunity to create a pharmacokinetic analysis of drug levels to be expected at given rates of intake (adherence).
After randomization, participants completed a 24-week period of self-administered dosing (Weeks 6 through 30), with one visit four weeks after the completion of dosing (34 weeks total).
Final study visit at 34 weeks, 4 weeks after ending self-administered dosing
The regimens used in this trial and the definition of PrEP coverage was based on information that was available when the trial was designed in 2010. More current information suggests that higher concentrations of PrEP medications are required for protection from vaginal exposure to HIV, as would be afforded by daily oral dosing or any topical dosing.
Coverage
Definition is the same for all 3 arms.
Only vaginal and anal sex acts will be considered; oral sex acts will not be included.
Periods of product hold (prior to acquisition of HIV) are included
The date and time of the sex act will be compared to the data and time of pill use as reported on item 2 of the Weekly Interview Log. A sex act will be considered “covered” if the following two conditions are met:
i) At least one pill is taken during the 96 hours before the act
ii) A pill is taken within 24 hours after the act
Note that the same pill can cover a post-exposure dose for one event and a pre-exposure dose for a different event.