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

Delaugerre, Constancea,b; Rodriguez, Christophec,d; Capitant, Catherinee; Nere, Marie-Laurea,b; Mercier-Darty, Mélaniec,d; Carette, Dianee; Pialoux, Gillesf; Cotte, Laurentg; Charreau, Isabellee; Molina, Jean-Michelb,h and the IPERGAY study group

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.

aVirologie, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris

bINSERM UMR 941, Université de Paris Diderot, Sorbonne Paris Cité

cVirologie, Hôpital Henri-Mondor, Assistance Publique Hôpitaux de Paris, Créteil

dINSERM U955, Team 18, Université Paris-Est Créteil

eINSERM SC10 US19, Villejuif

fMaladies infectieuses, Hôpital Tenon, Assistance Publique Hôpitaux de Paris

gMaladies infectieuses, Hôpital de la Croix Rousse, Centre Hospitalier et Universitaire de Lyon

hMaladies infectieuses, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.

Correspondence to Constance Delaugerre, Hôpital Saint Louis, Assistance Publique Hôpitaux de Paris, 1 avenue Claude Vellefaux, 75010 Paris, France. E-mail:

Received 30 January, 2018

Revised 12 March, 2018

Accepted 19 March, 2018

Copyright © 2018 Wolters Kluwer Health, Inc.