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

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

Author information

1
Virologie, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris.
2
INSERM UMR 941, Université de Paris Diderot, Sorbonne Paris Cité.
3
Virologie, Hôpital Henri-Mondor, Assistance Publique Hôpitaux de Paris, Créteil.
4
INSERM U955, Team 18, Université Paris-Est Créteil.
5
INSERM SC10 US19, Villejuif.
6
Maladies infectieuses, Hôpital Tenon, Assistance Publique Hôpitaux de Paris.
7
Maladies infectieuses, Hôpital de la Croix Rousse, Centre Hospitalier et Universitaire de Lyon.
8
Maladies infectieuses, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.

Abstract

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.

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