Use Of Oral Pre-exposure Prophylaxis Research Articles

The Road Ahead: Working Towards Effective Clinical Translation of Biomedical HIV Prevention Strategies

ABSTRACT Emerging evidence from several randomized controlled trials show that antiretroviral-based biomedical HIV prevention interventions are efficacious in preventing HIV if they are taken as directed, and could potentially reduce the number of new HIV infections globally. Strategies such as treatment as prevention and use of oral pre-exposure prophylaxis for HIV prevention have shown great promise, yet have raised important implementation concerns around awareness and acceptance, delivery, adherence, side effects, risk compensation, cost–effectiveness and drug resistance. In order to address these issues, a number of treatment as prevention and pre-exposure prophylaxis demonstration projects have been initiated to assess the feasibility of introducing these interventions in ‘real-world’ settings. These projects will be instrumental in determining best practices for optimal delivery and sustainability of these HIV prevention interventions. The road to effective translation to clinical setting is promising, but comes with challenges which are not insurmountable.

Clinician attitudes toward CDC interim pre-exposure prophylaxis (PrEP) guidance and operationalizing PrEP for adolescents.

Prior to issuing formal HIV pre-exposure prophylaxis (PrEP) clinical practice guidelines in 2014, the US Centers for Disease Control and Prevention (CDC) had released interim guidance for oral PrEP use among adults. Because oral PrEP may be used off-label for youth and may soon be indicated for minor adolescents, we examined the potential adoption of the interim guidance among clinicians who care for HIV-infected and at-risk youth. Individual, semi-structured interviews were conducted with 15 US clinicians who were recruited through an adolescent HIV research network. The theory-driven interview guide, consisting primarily of open-ended questions, assessed demographics, familiarity with the guidance, attitudes toward the guidance, and attitudes toward the use of the guidance for adult and adolescent patients. Transcripts were analyzed using framework analysis. Most clinicians (11/15) reported that the guidance was compatible with their practice, although several reported that some aspects, particularly frequency of follow-up visits, needed to be tailored to meet their patients' needs. We found variability in clinician reported characteristics of appropriate PrEP candidates (e.g., youth with substance use and mental health issues were noted to be both suitable and unsuitable PrEP candidates) and PrEP use in serodiscordant couples (e.g., whether PrEP would be recommended to a patient whose HIV-infected partner is virally suppressed). Clinician reported steps for initiation, monitoring, and discontinuing PrEP were largely consistent with the guidance. The observed variability in clinician practice with regard to oral PrEP may be reduced through interventions to educate clinicians about the content and rationale for guideline recommendations.

Drug resistance and plasma viral RNA level after ineffective use of oral pre-exposure prophylaxis in women.

Pre-exposure prophylaxis (PrEP) with daily oral emtricitabine (FTC)/tenofovir disoproxil fumarate may select for drug resistance if there is low adherence. Plasma viral HIV-1 RNA level, CD4+ T-cell counts, and drug resistance were evaluated among seroconverting women in the FEM-PrEP trial (clinicaltrials.gov NCT00625404) using standard clinical tests, allele-specific PCR (ASPCR), and by deep sequencing. Tenofovir, FTC, and their intracellular metabolites were measured in plasma and cells. There was no difference in plasma HIV-1 RNA level or CD4+ cell count among seroconverters in the active arm versus those receiving placebo. Tenofovir resistance was not observed. FTC resistance was detected using clinical assays in five seroconverters (four in the active arm and one in the placebo arm); two in the active arm occurred among women having moderate concentrations of PrEP drugs in the blood. The first evidence of infection occurred at the first postenrollment visit in three of the four with FTC resistance, although none had detectable viral nucleic acids at enrollment. FTC-resistant minor variants were detected in an additional four seroconverters (one in the active arm and three in the placebo arm). Drug resistance detected during ineffective PrEP use had characteristics suggesting transmitted infection or incubating infection prior to starting PrEP.

Moving the Bar to the Right Place: Positioning Interventions in HIV Prevention

Moving the Bar to the Right Place: Positioning Interventions in HIV Prevention

Awareness of and Willingness to Use Oral Pre-Exposure Prophylaxis for HIV Prevention among HIV-Serodiscordant Heterosexual Couples: A Cross-Sectional Survey in Xinjiang, China

ObjectivesWe aimed to investigate the awareness of and willingness to use oral pre-exposure prophylaxis (PrEP) for HIV prevention among HIV-negative partners in HIV-serodiscordant heterosexual couples in Xinjiang, China and determine factors that predict willingness to use oral PrEP.MethodsBetween November 2009 and December 2010, a cross-sectional survey was carried out among 351 HIV-negative partners in HIV-serodiscordant heterosexual couples from three cities in Xinjiang, China. Participants completed a self-administered questionnaire to assess their awareness of and willingness to use oral PrEP. Additionally, blood samples were collected to test for HIV infection. Univariate and multivariate logistic regression analyses were performed to identify predictors of willingness to use oral PrEP.ResultsOnly 10 participants (2.8%) reported having heard of PrEP, and only two reported ever using PrEP. However, 297 (84.6%) reported that they were willing to use oral PrEP if it was proven to be both safe and effective. Results of multivariate analysis revealed the following independent predictors of willingness to use oral PrEP: monthly household income (adjusted odds ratio = 2.78, <1000 RMB vs. ≥1000 RMB, 95% confidence interval: 1.36–5.69), perceived likelihood of contracting HIV from HIV-positive partner (adjusted odds ratio = 2.63, likely vs. unlikely, 95% confidence interval: 1.12–6.19), and worrying about being discriminated against by others due to oral PrEP use (adjusted odds ratio = 9.43, No vs. Yes, 95% confidence interval: 3.78–23.50).ConclusionsOur results showed HIV-negative partners in HIV-serodiscordant heterosexual couples in China had low awareness of oral PrEP but high willingness to use oral PrEP for HIV prevention. Cost of oral PrEP should be taken into consideration in future PrEP prevention strategy. In addition, efforts should be made to reduce stigma attached to oral PrEP use, which may increase its acceptability among potential users.

Preexposure Prophylaxis for HIV Prevention

Reducing the incidence of HIV remains one of our greatest public health challenges. However, there is growing optimism that preexposure prophylaxis (PrEP) could have a major impact on preventing incident HIV infection. Recently presented data on the use of oral PrEP in men who have sex with men (MSM) have provided proof-of-principle for this strategy. Additional clinical trials are evaluating whether PrEP provides similar protection to risk groups other than MSM, such as heterosexual persons and injection drug users. Still unanswered questions include optimal dosing strategies, long-term safety, maximizing adherence and minimizing costs, addressing drug resistance in the face of PrEP failure, optimizing access, and assessing effects on risk behavior. Future implementation will be guided by the results of clinical trials in progress. This article provides a review of the data on the potential strengths and limitations of PrEP as an HIV prevention strategy, identifies challenges to implementation of this approach, and outlines knowledge gaps.

Achieving safe conception in HIV-discordant couples: the potential role of oral preexposure prophylaxis (PrEP) in the United States

Approximately half of HIV-discordant heterosexual couples in the United States want children. Oral antiretroviral preexposure prophylaxis, if effective in reducing heterosexual HIV transmission, might be an option for discordant couples wanting to conceive. Couples should receive services to ensure they enter pregnancy in optimal health and receive education about all conception methods that reduce the risk of HIV transmission. In considering whether preexposure prophylaxis is indicated, the question is whether it contributes to lowering risk in couples who have decided to conceive despite known risks. If preexposure prophylaxis is used, precautions similar to those in the current heterosexual preexposure prophylaxis trials would be recommended, and the unknown risks of preexposure prophylaxis used during conception and early fetal development should be considered. Anecdotal reports suggest that oral preexposure prophylaxis use is already occurring. It is time to have open discussions of when and how preexposure prophylaxis might be indicated for HIV-discordant couples attempting conception.