| |
2 PrEP Studies IPERGAY & PROUD Announce Efficacy
|
| |
| |
Download the PDF here
Download the PDF here
from Jules: although the study investigators announced they stopped because they found the regimens to be effective, they have not yet released any of the actual data, so until we see the data it is premature to assume these unusual dosing approaches are effective & should be used by the public.
Press statement
UNAIDS welcomes new indications of effectiveness of antiretroviral medicines in preventing HIV among men who have sex with men
Independent monitoring bodies of two PrEP trials recommend offering antiretroviral medicines to all study participants
GENEVA, 29 October 2014-UNAIDS welcomes strong indications from two ongoing trials of the effectiveness of antiretroviral therapy in preventing new HIV infections among men who have sex with men.
The IPERGAY trial, conducted by the ANRS, the French National Agency for Research on AIDS and Viral Hepatitis, enrolled 400 men who have sex with men in France to establish the efficacy of taking the antiretroviral combination of tenofovir/emtricitabine as pre-exposure prophylaxis (PrEP) before and after sex rather than daily. The data safety and monitoring board for the IPERGAY trial reviewed data for the study and found a "very significant" reduction in the risk of HIV infection in the group of participants using tenofovir/emtricitabine as PrEP compared to the placebo group. The monitoring board subsequently recommended that the placebo group be stopped and that all trial participants should be offered tenofovir/emtricitabine as PrEP.
This announcement follows a recent decision to amend the PROUD study in the United Kingdom. In the PROUD study, the participants were initially placed at random into two groups-one group that used PrEP from the start of the study and another group that was due to receive PrEP after 12 months. However, the independent data monitoring committee found that the effectiveness seen in the trial exceeded the threshold set for trial continuation and recommended that the researchers offer daily PrEP to all study participants immediately.
Neither study is ready to present the full data for review. However, both independent monitoring bodies were clear that the results were so convincing that it would be unethical to allow the participants to continue without receiving PrEP. The final results of the IPERGAY and PROUD trials are expected to be presented in early 2015. Once the results are confirmed, antiretroviral medicines taken as PrEP before and after sex could become an additional HIV prevention option for men who have sex with men.
UNAIDS underlines that no single intervention is completely protective in preventing HIV transmission, which is why UNAIDS advocates strongly for combination HIV prevention. This includes correct and consistent use of condoms, delaying sexual debut, having fewer sexual partners, male circumcision, access to antiretroviral therapy, reducing stigma and discrimination, and the removal of punitive laws.
------------------
IPERGAY was a randomized trial of intermittent, "on demand" PrEP vs placebo done in high risk, HIV negative, men who have sex with men (MSM) in France and Canada. The specific strategy tested was:
· Two tablets of tenofovir/emtricitabine (Truvada) from 2-24 hours before sex
· One tablet 24 hours later
· Another tablet 24 hours after that one
So a total of 4 tablets over 3 days for episodic sexual activity, with an option for daily use for more frequent exposures.
- See more at:
http://blogs.jwatch.org/hiv-id-observations/index.php/why-ipergay-yes-thats-its-name-study-results-could-substantially-increase-use-of-prep/2014/10/30/#sthash.EcbOlHeb.dpuf
IPERGAY was a randomized trial of intermittent, "on demand" PrEP vs placebo done in high risk, HIV negative, men who have sex with men (MSM) in France and Canada. The specific strategy tested was:
· Two tablets of tenofovir/emtricitabine (Truvada) from 2-24 hours before sex
· One tablet 24 hours later
· Another tablet 24 hours after that one
So a total of 4 tablets over 3 days for episodic sexual activity, with an option for daily use for more frequent exposures.
- See more at:
http://blogs.jwatch.org/hiv-id-observations/index.php/why-ipergay-yes-thats-its-name-study-results-could-substantially-increase-use-of-prep/2014/10/30/#sthash.V0xzVpkL.dpuf
16 October 2014
The PROUD Study. (http://www.proud.mrc.ac.uk/) An interim analysis of the PROUD study data has shown that pre-exposure prophylaxis (PrEP) is highly protective against HIV for gay men and other men who have sex with men (MSM) at high risk of infection. On this basis, the PROUD Trial Steering Committee has announced that participants currently on the deferred arm of the study, who have not yet started PrEP, will be offered the opportunity to begin PrEP ahead of schedule......Read more
PROUD is a two-year study to recruit volunteers across England, who will be placed at random into one of two groups. One group will use PrEP from the start of the study, and the other group will receive PrEP after 12 months.
Truvada (which contains tenofovir and emtricitabine, also called FTC) is used in this study. Truvada is already widely used and any side effects are usually mild.
http://www.hivnet.ubc.ca/clinical-studies/canadian-hiv-trials-database/ctn268/
http://www.ipergaymtl.com/en/home.html
At AIDS 2014 Melbourne
High adherence rate to intermittent oral PrEP with TDF/FTC among high risk MSM (ANRS Ipergay)
Presented by Jean-Michel Molina (France).
J. Fonsart1, C. Capitant2, B. Spire3,4, L. Cotte5,6, G. Pialoux7, N. Lorente3,4, G. Peytavin8,9, I. Charreau2, J.-P. Aboulker2, J.-M. Molina10, ANRS Ipergay Study Group
1Saint-Louis Hospital, Biochimie, Paris, France, 2INSERM, SC10-US019, Villejuif, France, 3INSERM, UMR912 (SE4S), Marseille, France, 4Aix Marseille University, IRD, UMR-S912, Marseille, France, 5Hospices Civils de Lyon, Infectious Diseases, Lyon, France, 6INSERM, U1052, Lyon, France, 7Tenon Hospital, Infectious Diseases, Paris, France, 8Bichat Hospital, Laboratoire de Pharmaco-Toxicologie, Paris, France, 9INSERM, UMR 1137, Paris, France, 10Saint-Louis Hospital, Infectious Diseases, Paris, France
Background: Adherence is a critical factor associated with PrEP efficacy. Long-term adherence to daily oral PrEP remains challenging. Intermittent oral PrEP might improve adherence. We assessed adherence to intermittent PrEP among participants (pts) enrolled in the ANRS Ipergay trial.
Methods: High risk MSM are enrolled in an ongoing, randomized, double-blind, placebo-controlled trial of on demand PrEP with oral TDF/FTC. Pts were instructed to take 2 pills of TDF/FTC or placebo before sex (2 to 24 hours before), and 2 pills after sex (1 pill every 24 hours). The trial is currently in its pilot phase to assess adherence and feasibility. Adherence was assessed by computer-assisted self-interviews (CASIs) performed before visits, pill count, and assessment of TFV and FTC concentrations in plasma and hair samples. TFV and FTC concentrations were measured centrally, blinded to the randomization arm, using a sensitive LC-MS/MS assay (LLOD in plasma: 0.1 and 0.4 ng/ml for TFV and FTC respectively).
Results: From February 2012 to May 2013, 153 pts were randomized. Median age: 35 years (IQR: 20-61), follow-up: 98.6 pt-years, median number of sexual intercourses/week: 2 (range: 0-31), and number of sexual partners/2 months: 10 (range: 0-84). During their last sexual intercourse (n=543), according to CASIs: 53% (44-66% according to study visits) of pts used PrEP as scheduled, 28% (15-38%) used PrEP but did not follow the treatment schedule, and 19% (15-23%) did not use PrEP. Only 3% were using daily PrEP. The median number of pills used was 15 per month (IQR: 8-23). Only 59 hair samples from 38 pts were available for analysis. TFV and FTC were detected in 51% and 49% of pts in the TDF/FTC arm, and 14% and 0% in the placebo arm, respectively. 548 plasma samples from the first 113 randomized pts were analyzed. TFV and FTC were detected in 86% (82-100% according to study visits) and 82% (75-100%) of pts in the TDF/FTC arm, and 4% (0-6%) and 3% (0-6%) in the placebo arm, respectively.
Conclusions: Preliminary assessment of adherence among high risk MSM enrolled in this on demand PrEP trial, revealed a high adherence rate.
|
|
| |
| |
|
|
|
