Current concepts for PrEP adherence in the PrEP revolution

Available evidence supports the efficacy of pre-exposure prophylaxis (PrEP) in decreasing the incidence of human immunodeficiency virus (HIV) infection among high-risk individuals, especially when used in combination with other behavioural preventive methods. Safety concerns about PrEP present challenges in the implementation and use of PrEP. The aim of this review is to discuss safety concerns observed in completed clinical trials on the use of PrEP. We performed a literature search on PrEP in PubMed, global advocacy for HIV prevention (Aids Vaccine Advocacy Coalition) database, clinical trials registry “http://www.clinicaltrials.gov” and scholar.google, using combination search terms ‘pre-exposure prophylaxis’, ‘safety concerns in the use of pre-exposure prophylaxis’, ‘truvada use as PrEP’, ‘guidelines for PrEP use’, ‘HIV pre-exposure prophylaxis’ and ‘tenofovir’ to identify clinical trials and literature on PrEP. We present findings associated with safety issues on the use of PrEP based on a review of 11 clinical trials on PrEP with results on safety and efficacy as at April 2016. We also reviewed findings from routine real-life practice reports. The pharmacological intervention for PrEP was tenofovir disoproxil fumarate/emtricitabine in a combined form as Truvada® or tenofovir as a single entity. Both products are efficacious for PrEP and seem to have a good safety profile. Regular monitoring is recommended to prevent long-term toxic effects. The main adverse effects observed with PrEP are gastrointestinal related; basically mild to moderate nausea, vomiting and diarrhea. Other adverse drug effects worth monitoring are liver enzymes, renal function and bone mineral density. PrEP as an intervention to reduce HIV transmission appears to have a safe benefit-risk profile in clinical trials. It is recommended for widespread use but adherence monitoring and real-world safety surveillance are critical in the post-marketing phase to ensure that the benefits observed in clinical trials are maintained in real-world use.

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“…Explanations provided include available evidence of PrEP efficacy and individual motivations and reasons for taking PrEP [46]. …”

Section: Resultsmentioning

confidence: 99%

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns

et al. 2017

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“…Additionally, qualitative data on PrEP facilitator for African-American youth suggest the importance of PrEP provision in settings that are familiar and can provide services without long waits. 62 Text-based adherence supports have been used in PrEP research 63,64 but not integrated into practice. Our findings contribute to a growing body of data suggesting that MSM of color are receptive to mobile health technologies for HIV prevention.…”

Section: Discussionmentioning

confidence: 99%

Enhancing PrEP Access for Black and Latino Men Who Have Sex With Men

Leluţiu-Weinberger

Golub

2016

JAIDS Journal of Acquired Immune Deficiency Syndromes

126

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Objective Implementation of HIV pre-exposure prophylaxis (PrEP) programs for populations with highest incidence is critical to reducing new infections in the United States. Black and Latino men who have sex with men (BLMSM) are disproportionately burdened by HIV. We examined differences in perceived barriers and facilitators to PrEP access for BLMSM compared to other MSM. Method MSM who met CDC criteria for PrEP (n = 491) completed measures of barriers and facilitators to PrEP at the systems-, provider-, and individual-levels. Multivariate analyses examined differences by race/ethnicity, adjusting for other sociodemographic factors. Results Compared to other MSM, BLMSM (56% of the sample) were more likely to have public insurance and access health care via public clinics (aOR 3.2, p< 0.001; aOR 2.4, p< 0.01). BLMSM were more likely to regard having to talk to their doctor about their sex life as a barrier to PrEP (aOR 3.7, p< 0.001), and less likely to endorse agency in medical decision-making (aOR .58, p< 0.001). BLMSM were more likely to report PrEP stigma (aOR 2.3, p< 0.001) and concerns regarding PrEP efficacy (aOR 1.6, p< 0.05). BLMSM were more likely to consider access to free sexual health care (aOR 2.1, 95% CI: 1.3-3.3; p< 0.01) and additional supportive services, e.g., counseling (aOR 3.1, p< 0.001) or text-based support (aOR 2.9, p< 0.001), to be significant facilitators of PrEP use. Conclusions Findings suggest specific points of multi-level intervention to increase PrEP access for BLMSM and increase representation of BLMSM along the PrEP continuum of care.

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“…Risk assessment tools have been designed for men who have sex with men (MSM) and people who inject drugs (PWID) but have not been critically evaluated yet in terms of their usefulness in PrEP implementation. Regardless of population and point of entry, evidence-based strategies to support adherence should be considered, without losing a user-centred approach, where risk reduction is the goal – rather than PrEP adherence per se [41]. Within the Partners PrEP study among HIV-negative members of serodiscordant couples in Kenya and Uganda, objective measures of PrEP adherence were collected using unannounced home-based pill counts and electronic pill bottle monitoring; participants received individual and couples-based adherence counselling at PrEP initiation and throughout the study; participants were followed monthly and counselling was intensified if unannounced pill count adherence fell to <80%.…”

Section: Discussionmentioning

confidence: 99%

Implementation of pre‐exposure prophylaxis for human immunodeficiency virus infection: progress and emerging issues in research and policy

Cáceres

Bórquez

Klausner

et al. 2016

Journal of the International AIDS Society

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BackgroundIn this article, we present recent evidence from studies focused on the implementation, effectiveness and cost-effectiveness of pre-exposure prophylaxis (PrEP) for HIV infection; discuss PrEP scale-up to date, including the observed levels of access and policy development; and elaborate on key emerging policy and research issues to consider for further scale-up, with a special focus on lower-middle income countries.DiscussionThe 2015 WHO Early Release Guidelines for HIV Treatment and Prevention reflect both scientific evidence and new policy perspectives. Those guidelines present a timely challenge to health systems for the scaling up of not only treatment for every person living with HIV infection but also the offer of PrEP to those at substantial risk. Delivery and uptake of both universal antiretroviral therapy (ART) and PrEP will require nation-wide commitment and could reinvigorate health systems to develop more comprehensive “combination prevention” programmes and support wider testing linked to both treatments and other prevention options for populations at highest risk who are currently not accessing services. Various gaps in current health systems will need to be addressed to achieve strategic scale-up of PrEP, including developing prioritization strategies, strengthening drug regulations, determining cost and funding sources, training health providers, supporting user adherence and creating demand.ConclusionsThe initial steps in the scale-up of PrEP globally suggest feasibility, acceptability and likely impact. However, to prevent setbacks in less well-resourced settings, countries will need to anticipate and address challenges such as operational and health systems barriers, drug cost and regulatory policies, health providers’ openness to prescribing PrEP to populations at substantial risk, demand and legal and human rights issues. Emerging problems will require creative solutions and will continue to illustrate the complexity of PrEP implementation.

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Current concepts for PrEP adherence in the PrEP revolution

Cited by 157 publications

References 54 publications

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns

Pre-Exposure Prophylaxis for HIV Prevention: Safety Concerns

Enhancing PrEP Access for Black and Latino Men Who Have Sex With Men

Implementation of pre‐exposure prophylaxis for human immunodeficiency virus infection: progress and emerging issues in research and policy

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