Randomized controlled trial of the tolerability and completion of maraviroc compared with Kaletra® in combination with Truvada® for HIV post-exposure prophylaxis (MiPEP Trial)

We present the updated British Association for Sexual Health and HIV guidelines for HIV post-exposure prophylaxis following sexual exposure (PEPSE). This document includes a review of the current data to support the use of PEPSE, considers how to calculate the risks of infection after a potential exposure, and provides recommendations on when PEPSE should and should not be considered. We also review which medications to use for PEPSE, provide a checklist for initial assessment, and make recommendations for monitoring individuals receiving PEPSE. Special scenarios, cost-effectiveness of PEPSE, and issues relating to service provision are also discussed. Throughout the document, the place of PEPSE within the broader context of other HIV prevention strategies is considered.

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“…Two RCTs concluded that a PEP regimen of Truvada plus maraviroc is better tolerated than Truvada plus Kaletra. 101,110…”

Section: Which Medication Regimen To Use For Pepsementioning

confidence: 99%

UK guideline for the use of HIV Post-Exposure Prophylaxis Following Sexual Exposure, 2015

Cresswell¹,

Waters²,

Briggs

et al. 2016

Int J STD AIDS

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“…A total of 1105 PEP initiations from five RCTs, four conducted in Spain and one in England, were included in the clinical trials analysed [10–14]. The study participants in all studies were principally men ( n = 941, 85%) and men who have sex with men ( n = 832, 75%); 247 (22%) were non‐Caucasian, 261 (24%) reported previous sexually transmitted infections (STIs) at the moment of inclusion in the studies and 759 (69%) had a previous HIV test.…”

Section: Resultsmentioning

confidence: 99%

“…LPV/r [17], because subjects were stratified by type of event (occupational vs . non‐occupational) and there were significantly more occupational exposures (21%) than in the other five trials which included manly non‐occupational exposures [10–14]. We assumed that the threshold of tolerance and/or risk perception of health workers and men who have sex with men exposed by sexual contact could be significantly different and, consequently, the possibility of abandoning the treatment or study may be intrinsically different between those two groups.…”

Section: Methodsmentioning

confidence: 99%

“…Few randomized studies have been conducted searching for better tolerated regimens as a priority [10–14]. It is not known which is the best tolerated regimen and, therefore, the recommendations of guidelines are mainly based on expert opinions [15].…”

Section: Introductionmentioning

confidence: 99%

“…It is not known which is the best tolerated regimen and, therefore, the recommendations of guidelines are mainly based on expert opinions [15]. To evaluate which PEP regimen has the best completion rate, we performed a network meta‐analysis (NMA) of five randomized clinical trials (RCTs) comparing different PEP regimens and reporting completion outcomes on 1105 PEP initiations [10–14].…”

Section: Introductionmentioning

confidence: 99%

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Network meta‐analysis of post‐exposure prophylaxis randomized clinical trials

et al. 2020

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Objectives We performed a network meta‐analysis of PEP randomized clinical trials to evaluate the best regimen. Methods After MEDLINE/Pubmed search, studies were included if: (1) were randomized, (2) comparing at least 2 PEP three‐drug regimens and, (3) reported completion rates or discontinuation at 28 days. Five studies with 1105 PEP initiations were included and compared ritonavir‐boosted lopinavir (LPV/r) vs. atazanavir (ATV) (one study), cobicistat‐boosted elvitegravir (EVG/c) (one study), raltegravir (RAL) (one study) or maraviroc (MVC) (two studies). We estimated the probability of each treatment of being the best based on the evaluation of five outcomes: PEP non‐completion at day 28, PEP discontinuation due to adverse events, PEP switching due to any cause, lost to follow‐up and adverse events. Results Participants were mostly men who have sex with men (n = 832, 75%) with non‐occupational exposure to HIV (89.86%). Four‐hundred fifty‐four (41%) participants failed to complete their PEP course for any reason. The Odds Ratio (OR) for PEP non‐completion at day 28 in each antiretroviral compared to LPV/r was: ATV 0.95 (95% CI 0.58–1.56; EVG/c: OR 0.65 95% CI 0.30–1.37; RAL: OR 0.68 95% CI 0.41–1.13; and MVC: OR 0.69 95% CI 0.47–1.01. In addition, the rankogram showed that EVG/c had the highest probability of being the best treatment for the lowest rates in PEP non‐completion at day 28, switching, lost to follow‐up or adverse events and MVC for PEP discontinuations due to adverse events. Conclusions Our study shows the advantages of integrase inhibitors when used as PEP, particularly EVG as a Single‐Tablet Regimen.

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Personalizing prevention: Advances in pharmacotherapy for HIV prevention

et al. 2023

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Randomized controlled trial of the tolerability and completion of maraviroc compared with Kaletra® in combination with Truvada® for HIV post-exposure prophylaxis (MiPEP Trial)

Abstract: The completion rate in the absence of grade 3 or 4 AEs was similar with both regimens. Maraviroc-based PEP was better tolerated, supporting its use as an option for non-occupational PEP.

Cited by 11 publications

References 31 publications

UK guideline for the use of HIV Post-Exposure Prophylaxis Following Sexual Exposure, 2015

UK guideline for the use of HIV Post-Exposure Prophylaxis Following Sexual Exposure, 2015

Network meta‐analysis of post‐exposure prophylaxis randomized clinical trials

Personalizing prevention: Advances in pharmacotherapy for HIV prevention

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