Type 1 Human Immunodeficiency Virus (HIV-1) Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-exposure Prophylaxis: Pooled Analysis From 72 Global Studies

Landovitz R.J.; Tao L.; Yang J.; de Boer M.; Carter C.; Das M.; Baeten J.M.; Liu A.; Hoover K.W.; Celum C.; Grinsztejn B.; Morris S.; Wheeler D.P.; Mayer K.H.; Golub S.A.; Bekker L.-G.; Diabaté S.; Hoornenborg E.; Myers J.; Leech A.A.; McCormack S.; Chan P.A.; Sweat M.; Matthews L.T.; Grant R.; Beyrer C.; Brown J.; Clark J.; Colson P.; Eakle R.; Farley J.; Flash C.A.; Gallardo J.; Gottlieb G.; Grangeiro A.; Heffron R.; Hosek S.; Hull M.; Idoko J.; Inwani I.; Koenig H.; Kurth A.; Lee S.-S.; Mayer K.; Mboup S.; Meyer J.; Mills A.; Mujugira A.; Pala P.; Phoenix J.; Piatt J.; Russell D.; Sanders E.; Scott R.; Sevelius J.; Shang H.; Siegel M.; Swaminathan S.; Tamayo V.; Tan D.; Taylor A.; Vuylsteke B. · Clinical Infectious Diseases (2024) · DOI: 10.1093/cid/ciae143

Resumen

Background. Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. Methods. HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentrations in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. Results. Among 17 274 participants, there were 101 cases with new HIV-1 diagnosis (.77 per 100 person-years; 95% confidence interval [CI]: .63–.94). In 78 cases with resistance data, 18 (23%) had M184I or V, 1 (1.3%) had K65R, and 3 (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2−3, 4−6, and ≥7 doses/wk, respectively, and the corresponding incidence was 3.9 (95% CI: 2.9–5.3), .24 (.060–.95), .27 (.12–.60), and .054 (.008–.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. Conclusions. Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure. © The Author(s) 2024.

Instituciones: Universidad Nacional Mayor de San Marcos