Article

Safety and adherence to intermittent pre-exposure prophylaxis (PrEP) for HIV-1 in African men who have sex with men and female sex workers.

Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya.
PLoS ONE (Impact Factor: 3.53). 04/2012; 7(4):e33103. DOI: 10.1371/journal.pone.0033103
Source: PubMed

ABSTRACT Little is known about safety of and adherence to intermittent HIV PrEP regimens, which may be more feasible than daily dosing in some settings. We present safety and adherence data from the first trial of an intermittent PrEP regimen among Kenyan men who have sex with men (MSM) and female sex workers (FSW).
MSM and FSW were randomized to daily oral FTC/TDF or placebo, or intermittent (Monday, Friday and within 2 hours after sex, not to exceed one dose per day) oral FTC/TDF or placebo in a 2:1:2:1 ratio; volunteers were followed monthly for 4 months. Adherence was assessed with the medication event monitoring system (MEMS). Sexual activity data were collected via daily text message (SMS) queries and timeline followback interviews with a one-month recall period. Sixty-seven men and 5 women were randomized into the study. Safety was similar among all groups. Median MEMS adherence rates were 83% [IQR: 63-92] for daily dosing and 55% [IQR:28-78] for fixed intermittent dosing (p = 0.003), while adherence to any post-coital doses was 26% [IQR:14-50]. SMS response rates were low, which may have impaired measurement of post-coital dosing adherence. Acceptability of PrEP was high, regardless of dosing regimen.
Adherence to intermittent dosing regimens, fixed doses, and in particular coitally-dependent doses, may be more difficult than adherence to daily dosing. However, intermittent dosing may still be appropriate for PrEP if intracellular drug levels, which correlate with prevention of HIV acquisition, can be attained with less than daily dosing and if barriers to adherence can be addressed. Additional drug level data, qualitative data on adherence barriers, and better methods to measure sexual activity are necessary to determine whether adherence to post-coital PrEP could be comparable to more standard regimens.
ClinicalTrials.gov NCT00971230.

0 Bookmarks
 · 
195 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: Oral pre-exposure prophylaxis (PrEP) is in its infancy as an approved biomedical intervention; therefore, research is needed to understand the issues surrounding its implementation. The purpose of this literature review is to report the empirical research about PrEP to identify the salient issues surrounding its implementation. PubMed, Medline, and CINAHL databases were searched yielding 45 articles meeting inclusion criteria for the review. Overall, we found patient awareness of PrEP varied and its use was low. Awareness was higher among providers. Patients were willing to use PrEP, but both patients’ and providers’ concerns may have impacted implementation of this intervention. PrEP requires a prescription, yet only 5 of the 45 articles addressed provider-level factors. Research involving providers is needed to ensure that patient risk of becoming infected with HIV is accurately assessed, that PrEP is provided to those at high risk for HIV infection, and that frequent follow-up is conducted.
    Journal of the Association of Nurses in AIDS Care 11/2014; 25(6). DOI:10.1016/j.jana.2014.07.005 · 1.23 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The efficacy of pre-exposure-prophylaxis (PrEP) in HIV can diminish with poor adherence; pharmacologic measures of drug exposure have proven critical to PrEP trial interpretation. We assessed drug exposure in hair against other pharmacologic and more routinely-used measures to assess pill-taking.
    JAIDS Journal of Acquired Immune Deficiency Syndromes 10/2014; 68(1). DOI:10.1097/QAI.0000000000000386 · 4.39 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Serodiscordant couples play an important role in maintaining the global HIV epidemic. This review summarizes biobehavioral and biomedical HIV prevention options for serodiscordant couples focusing on advances in 2013 and 2014, including World Health Organization guidelines and best evidence for couples counseling, couple-based interventions, and the use of antiviral agents for prevention. In the past few years, marked advances have been made in HIV prevention for serodiscordant couples and numerous ongoing studies are continuously expanding HIV prevention tools, especially in the area of pre-exposure prophylaxis. Uptake and adherence to antiviral therapy remains a key challenge. Additional research is needed to develop evidence-based interventions for couples, and especially for male-male couples. Randomized trials have demonstrated the prevention benefits of antiretroviral-based approaches among serodiscordant couples; however, residual transmission observed in recognized serodiscordant couples represents an important and resolvable challenge in HIV prevention.
    Current HIV/AIDS Reports 08/2014; DOI:10.1007/s11904-014-0225-9

Full-text (2 Sources)

Download
43 Downloads
Available from
Jun 3, 2014