Use of PCR Signal and Therapeutic Drug Monitoring in a Switch Cohort Study to Tenofovir/Emtricitabine/Rilpivirine: A W96 Follow-Up

PLoS One. 2015 Jul 30;10(7):e0134430. doi: 10.1371/journal.pone.0134430. eCollection 2015.

Abstract

Objective: To assess, in a clinical cohort, the efficacy of switching treatment in virologically-suppressed patients to tenofovir/emtricitabine/rilpivirine as a single-tablet regimen (STR) using the PCR signal of the viral load (VL) assay and plasma drug determination (C24h).

Patients and methods: An observational single-centre study enrolling patients with VL<50 copies/mL initiating rilpivirine-based STR. C24h and VL were performed until W48 and W96 of STR, respectively. PCRneg was defined as an undetected PCR signal. Medians (IQR) were presented.

Results: 116 patients were enrolled. At STR baseline, time since first antiretroviral therapy and time of virological suppression were 6 years (2-9) and 17 months (7-43), respectively. Before STR initiation, patients were receiving protease inhibitors and non-nucleoside reverse transcriptase inhibitors-based regimen in 44% and 47% of cases, respectively. Historical genotype showed virus resistant to one drug of the STR in 6 patients (5%). At W96, 17 (15%) discontinued STR due to adverse events. The proportion of patients maintaining VL <50 copies/mL on treatment was 98%, 99%, 100%, 100%, 100% and 100% at W12, W24, W36, W48, W72 and W96, respectively. Among them, 70%, 66%, 68%, 59%, 74%, 68% and 60% were PCRneg at baseline, W12, W24, W36, W48, W72 and W96, respectively. Median rilpivirine C24h was 91 ng/mL (57-141, n = 285), with 91% of rilpivirine C24h >50 ng/mL, the target effective concentration.

Conclusions: In this clinical cohort of virologically-suppressed patients switching to a new STR, most subjects had adequate rilpivirine C24h and displayed a high level of virological suppression with no residual viremia until W96.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents / administration & dosage*
  • Anti-HIV Agents / blood
  • Anti-HIV Agents / therapeutic use
  • Drug Combinations
  • Drug Substitution
  • Drug Therapy, Combination
  • Emtricitabine / administration & dosage*
  • Emtricitabine / blood
  • Emtricitabine / therapeutic use
  • Emtricitabine, Rilpivirine, Tenofovir Drug Combination / administration & dosage*
  • Emtricitabine, Rilpivirine, Tenofovir Drug Combination / therapeutic use
  • Female
  • Follow-Up Studies
  • HIV Infections / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Rilpivirine / administration & dosage*
  • Rilpivirine / blood
  • Rilpivirine / therapeutic use
  • Tenofovir / administration & dosage*
  • Tenofovir / blood
  • Tenofovir / therapeutic use
  • Viral Load / drug effects*

Substances

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

Grants and funding

The research leading to these results has received funding from the French National Agency for Research on AIDS and Viral Hepatitis (ANRS).