Single-Tablet Emtricitabine-Rilpivirine-Tenofovir as HIV Postexposure Prophylaxis in Men Who Have Sex With Men

Clin Infect Dis. 2015 Oct 15;61(8):1336-41. doi: 10.1093/cid/civ511. Epub 2015 Jun 29.

Abstract

Background: Completion rates for human immunodeficiency virus (HIV) postexposure prophylaxis (PEP) are low. We investigated the adherence and safety of coformulated emtricitabine (FTC), rilpivirine (RPV), and tenofovir disoproxil fumarate (TDF) as a 3-drug, single-tablet regimen for PEP in men who have sex with men (MSM).

Methods: In an open-label, single-arm study at 2 public sexual health clinics and 2 hospital emergency departments in urban Australia, 100 HIV-uninfected MSM requiring 3-drug PEP received single-tablet FTC-RPV-TDF once daily for 28 days. The primary endpoint was premature PEP cessation or primary HIV infection through week 12. Additional endpoints were adherence (by self-report of doses missed or not ingested with a meal, by pill count, and by plasma concentrations of tenofovir and FTC at week 4); and safety (clinical and laboratory adverse events [AEs]).

Results: PEP completion was 92% (95% confidence interval, 85%-96%); premature cessation resulted from loss to follow-up (6%), AEs (1%), or study burden (1%). No participant was found to acquire HIV through week 12. Adherence was 98.6% (standard deviation [SD], 2.4) by pill count and 98.5% (SD, 2.7) by self-report; 86% reported taking all doses with food, and 88% of the subset tested had plasma tenofovir levels suggesting full adherence (>40 ng/mL). Eighty-eight participants experienced at least 1 clinical AE; 4 had grade 3 AEs or higher, possibly attributable to study drug. Fifty-six participants experienced at least 1 laboratory AE; 4 had AEs of grade 3 or higher, possibly attributable to study drug.

Conclusions: A single-tablet regimen of FTC-RPV-TDF was well tolerated as once-daily PEP, with high levels of adherence and completion.

Clinical trials registration: NCT01715636.

Keywords: HIV; adherence; completion; postexposure prophylaxis; rilpivirine.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / blood
  • Anti-HIV Agents / therapeutic use
  • Australia
  • Drug Administration Schedule
  • Emtricitabine, Rilpivirine, Tenofovir Drug Combination / administration & dosage*
  • Emtricitabine, Rilpivirine, Tenofovir Drug Combination / blood
  • Emtricitabine, Rilpivirine, Tenofovir Drug Combination / therapeutic use
  • HIV Infections / prevention & control*
  • Homosexuality, Male*
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Post-Exposure Prophylaxis*
  • Tablets
  • Young Adult

Substances

  • Anti-HIV Agents
  • Emtricitabine, Rilpivirine, Tenofovir Drug Combination
  • Tablets

Associated data

  • ClinicalTrials.gov/NCT01715636