Drug resistance among patients who acquired HIV infection in a preexposure prophylaxis trial

AIDS. 2018 Oct 23;32(16):2353-2361. doi: 10.1097/QAD.0000000000001960.


Background: The IPERGAY ANRS trial showed that on-demand preexposure prophylaxis (PrEP) with tenofovir (TDF) and emtricitabine (FTC) was highly effective in preventing HIV infection among highly exposed MSM. Here, we analyzed drug resistance-associated mutations (RAMs) among all participants who acquired HIV infection during this trial.

Methods: Resistance was analyzed on frozen plasma at the time of HIV diagnosis among participants enrolled in the double-blind and open-label phases of the ANRS IPERGAY trial. Reverse transcriptase sequencing was performed, using population-based and ultradeep sequencing (454 GS Flex). Adherence was measured by pill counting and by plasma tenofovir and FTC assay.

Results: During the trial, 31 participants were diagnosed with HIV-1 infection (subtype B, 64.5%), using antigen/antibody immune assay in 29 cases and plasma HIV RNA assay in two. The median plasma HIV-1 RNA level was 5.52 log10 copies/ml. Drug resistance was tested in 12 participants before starting PrEP, in six assigned to TDF/FTC group and in 13 assigned to placebo group. Primary resistance to nucleoside reverse transcriptase inhibitors (zidovudine) and/or nonnucleoside reverse transcriptase inhibitors was detected in six participants (19%; 95% confidence interval 7-42). No major or minor TDF-resistant or FTC-resistant variants were detected.

Conclusion: No TDF or FTC resistance-associated mutations were found among participants who acquired HIV in the ANRS IPERGAY trial.

MeSH terms

  • Clinical Trials as Topic
  • Double-Blind Method
  • Drug Resistance, Viral*
  • Genotype
  • HIV Infections / prevention & control*
  • HIV Infections / virology*
  • HIV Reverse Transcriptase / genetics
  • HIV-1 / drug effects*
  • HIV-1 / genetics
  • High-Throughput Nucleotide Sequencing
  • Humans
  • Male
  • Mutation*
  • Placebos / administration & dosage
  • Pre-Exposure Prophylaxis / methods*
  • Sequence Analysis, DNA
  • Treatment Failure


  • Placebos
  • HIV Reverse Transcriptase