The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Efficacy, safety, and effect on sexual behaviour of on-demand pre-exposure prophylaxis for HIV in men who have sex with men: an observational cohort study.
Open accessAbstract
Background Data for on-demand pre-exposure prophylaxis (PrEP) are scarce. We implemented a cohort study to assess its efficacy, safety, and effect on sexual behaviour.Methods We invited men and transgender women who have sex with men, previously enrolled in the randomised placebo-controlled ANRS IPERGAY trial at seven sites (six in France and one in Canada), to participate in an open-label extension with on-demand tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg) to be taken before and after sexual intercourse. We assessed the incidence of HIV and other sexually transmitted infections (STIs), PrEP adherence, safety, and sexual behaviour. Statistical analyses included comparisons of proportions and incidence between the randomised phase of the ANRS IPERGAY trial and the open-label phase, and all participants were included in safety analyses. ANRS IPERGAY is registered with ClinicalTrials.gov, number NCT01473472.Findings Between Nov 4, 2014, and Jan 27, 2015, we enrolled 361 participants. Median follow-up was 18·4 months (IQR 17·7-19·1). One participant who discontinued PrEP acquired HIV infection. HIV incidence was 0·19 per 100 person-years (95% CI 0·01-1·08), compared with 6·60 per 100 person-years (3·60-11·05) in the placebo group of the randomised study, indicating a relative reduction of 97% (95% CI 81-100) in the incidence of HIV with on-demand PrEP. Participants used a median of 18 pills of study drugs per month (IQR 11-25), and at the 6 month visit 240 (71%) of 336 participants had tenofovir detected in plasma. Drug-related gastrointestinal events were reported in 49 participants (14%) but were self-limited. Only four participants (1%) discontinued PrEP, three because of an increase in plasma creatinine. The proportion of participants reporting condomless sex at their last receptive anal intercourse significantly increased from 77% (136 of 176 participants) at baseline to 86% (66 of 77 participants) at 18 months' follow-up (p for trend=0·0004). The incidence of a first bacterial STI during this open-label phase did not change significantly compared with the randomised phase (59·0 vs 49·1 per 100 person-years, respectively; p=0·11).Interpretation On-demand oral PrEP is highly effective at preventing HIV infection among high-risk men who have sex with men and therefore represents an alternative to daily PrEP, expanding choices for HIV prevention. High rates of STIs resulting from low condom use did not undermine PrEP efficacy, but warrant frequent testing.Funding ANRS (France Recherche Nord and Sud Sida-HIV Hépatites), the Canadian HIV Trials Network, Fonds Pierre Bergé-Sidaction, Gilead Sciences, and the Bill & Melinda Gates Foundation.
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“Studies conducted with MSM have demonstrated that taking PrEP at specific times before and after sexual intercourse was effective in preventing HIV; however, less experience exits with this regimen, it is not FDA cleared, and it has not been studied among other populations (79).”
From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [79]
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Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
Grant, R. M., Lama, J. R., Anderson, P. L., McMahan, V., Liu, A. Y., Vargas, L., Goicochea, P., Casapía, M., Guanira-Carranza, J. V., Ramirez-Cardich, M. E., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1011205 · Cited by 5,096
Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.
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On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection
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Self-citationPreexposure Prophylaxis for HIV Infection among African Women
Damme, L. V., Corneli, A. L., Ahmed, K., Agot, K. E., Lombaard, J. J., Kapiga, S., Malahleha, M., Owino, F., Manongi, R. N., Onyango, J., et al. (2012) · New England Journal of Medicine · doi:10.1056/nejmoa1202614 · Cited by 1,633
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Tenofovir-based preexposure prophylaxis for HIV infection among African women.
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Sexually Transmitted Infections Treatment Guidelines, 2021
Workowski, K. A., Bachmann, L. H., Chan, P. A., Johnston, C. M., Muzny, C. A., Park, I., Reno, H., Zenilman, J. M., & Bolan, G. A. (2021) · MMWR. Recommendations and Reports · doi:10.15585/mmwr.rr7004a1 · Cited by 3,018
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Self-citationMolina, J.-M., Charreau, I., Chidiac, C., Pialoux, G., Cua, E., Delaugerre, C., Capitant, C., Rojas-Castro, D., Fonsart, J., Bercot, B., et al. (2018) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(17)30725-9 · Cited by 449
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Metadata
- Authors
- Molina, J.-M., Charreau, I., Spire, B., Cotte, L., Chas, J., Capitant, C., Tremblay, C., Rojas-Castro, D., Cua, E., Pasquet, A., Bernaud, C., Pintado, C., Delaugerre, C., Sagaon-Teyssier, L., Mestre, S. L., Chidiac, C., Pialoux, G., Ponscarme, D., Fonsart, J., Thompson, D., Wainberg, M. A., Doré, V., Meyer, L., Meyer, L., Capitant, C., Charreau, I., Netzer, E., Leturque, N., Binesse, J., Foubert, V, Saouzanet, M., Euphrasie, F., Carette, D., Guillon, B., Saïdi, Y., Aboulker, J. P., Spire, B., Suzan, M., Cattin, G., Demoulin, B., Sagaon-Teyssier, L., Lorente, N., Doré, V, Choucair, E., Le Mestre, S., Mennecier, A., Etien, N., Simon, M. C., Diallo, A., Gibowski, S., Delfraissy, J. F., Thompson, D., Sas, J., Pankovitch, J., Klein, M., Anis, A., Molina, J.-M., Wainberg, M. A., Trottier, B., Tremblay, C., Baril, J.-G., Pialoux, G., Cotte, L., Chéret, A., Pasquet, A., Cua, E., Besnier, M., Rozenbaum, W., Chidiac, C., Delaugerre, C., Bajos, N., Timsit, J., Peytavin, G., Fonsart, J., Durand-Zaleski, I., Meyer, L., Aboulker, J.-P., Spire, B., Suzan-Monti, M., Girard, G., Castro, D. R., Préau, M., Morin, M., Thompson, D., Capitant, C., Mennecier, A., Choucair, E., Doré, V., Simon, M.-C., Charreau, I., Otis, J., Lert, F., Diallo, A., Gibowski, S., & Rabian, C.
- Affiliations
- Hôpital Tenon (FR)
- Assistance Publique – Hôpitaux de Paris (FR)
- Inserm (FR)
- Agence Nationale de Recherches sur le Sida et les Hépatites Virales (FR)
- RÉZO (CA)
- ORCID
- Venue
- The Lancet HIV
- Publisher
- Elsevier BV
- Published
- 2017-09
- Volume
- 4
- Issue
- 9
- Pages
- e402-e410
- ISSN
- 2352-3018 (ISSN-L)
- OpenAlex
- W2738559785
- Cited by
- 472
- References
- 21
- Citations by year
- 2026: 25 · 2025: 41 · 2024: 26 · 2023: 47 · 2022: 76 · 2021: 63 · 2020: 79 · 2019: 67 · 2018: 41 · 2017: 6
- FWCI
- 40.64
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet HIV (acceptedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Funders
- ANRS (France Recherche Nord and Sud Sida-HIV Hépatites)
- Canadian HIV Trials Network
- Fonds Pierre Bergé—Sidaction
- Gilead Sciences
- Bill & Melinda Gates Foundation
- Merck
- ViiV Healthcare
- Pfizer
- BMS
- National Agency for Research on AIDS and Hepatitis
- ANRS
- Fondation Pierre Bergé pour la prevention/Sidaction
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Health Sciences › Medicine › Epidemiology › HIV, Drug Use, Sexual Risk
- Keywords
- HIV pre-exposure prophylaxis, on-demand PrEP, men who have sex with men, transgender women, tenofovir disoproxil fumarate, emtricitabine, HIV incidence, PrEP adherence, sexually transmitted infections, unprotected sex, anal sex, open-label extension, HIV prevention, drug-related adverse events
- MeSH terms
- Emtricitabine, Tenofovir, Adolescent, Adult, Canada, Follow-Up Studies, France, Humans, Male, Middle Aged, Sexual Behavior, Cohort Studies, HIV-1, HIV Infections, Randomized Controlled Trials as Topic, Condoms, Homosexuality, Male, Anti-HIV Agents, Medication Adherence, Young Adult, Pre-Exposure Prophylaxis
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