Decay kinetics of HIV-1-RNA in seminal plasma with dolutegravir/lamivudine versus dolutegravir plus emtricitabine/tenofovir alafenamide in treatment-naive people living with HIV.

"Funding: This work was supported by a collaboration agreement between Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI) and ViiV Healthcare UK Ltd. The funders had no role in study design, data collection, analysis, conclusions, publication decision or manuscript preparation. There was no financial compensation to researchers. Instituto de Salud Carlos III through the Subprogram Miguel Servet (CP19/00159) to A.G.V., PFIS contracts (FI19/00304) to E.M.M. and (FI21/00165) to A.S.A., from the Ministerio de Ciencia e Innovación, Spain. All of them co-financed by the European Regional Development Fund ‘a way to make Europe’. Transparency declarations: L.F.L.C. has received unrestricted research funding outside the submitted work from Gilead Sciences, Merck Sharp & Dohme, and ViiV Healthcare, and consultancy fees and lecture fees from Gilead Sciences and ViiV Healthcare. L.E.L.C. has served as a scientific advisor for Angelini, speaker for Angelini, ViiV Healthcare, Gilead Sciences and Correvio, and trainer for ViiV Healthcare. N.E. has received fees as a consultant and speaker from ViiV Healthcare, Merck Sharp & Dohme and Gilead Sciences, and travel grants from Gilead Sciences and Merck Sharp for attending conferences. M.T.R., A.S.G., M.D.M., E.M.M., C.S., M.H. and A.G.V. have received travel grants for attending conferences from Gilead Sciences.: Author contributionsL.F.L.C. and A.G.V. designed the study and obtained funding. L.F.L.C., M.D.M., L.E.L.C., N.E., C.R.C., C.S. and M.H. recruited and followed-up study volunteers. A.S.A., M.T.R., A.S.G. and M.C.L. collected, processed and analysed clinical samples. A.S.A., E.M.M. and M.D.M. collected and managed the database. L.F.L.C., J.M.P.F. and A.S.A. performed data analyses. A.S.A., A.G.V and L.F.L.C. drafted the original manuscript. All authors participated in reviewing and editing the manuscript."

"Funding This work was supported by a collaboration agreement between Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI) and ViiV Healthcare UK Ltd. The funders had no role in study design, data collection, analysis, conclusions, publication decision or manuscript preparation. There was no financial compensation to researchers. Instituto de Salud Carlos III through the Subprogram Miguel Servet (CP19/00159) to A.G.V., PFIS contracts (FI19/00304) to E.M.M. and (FI21/00165) to A.S.A., from the Ministerio de Ciencia e Innovación, Spain. All of them co-financed by the European Regional Development Fund ‘a way to make Europe’."

"This was a substudy of the investigator-initiated Phase IV, randomized, open-label clinical trial (ClinicalTrials.gov identifier: NCT04295460; EMA, No EudraCT: 2019-000800-14) conducted in several hospitals in Andalucía, Spain. Participants were asymptomatic MSM, treatment-naive PLWH older than 18 years, with CD4+ T cell counts >200 cells/mm3 and plasma HIV-1-RNA levels between 5000 and 500 000 copies/mL. Exclusion criteria included HIV resistance to the study drugs, active sexually transmitted infections screened at baseline (syphilis, gonorrhoea, Chlamydia trachomatis and Mycoplasma genitalium) or presence of symptoms later, opportunistic infection, HBV or HCV coinfection, cirrhosis, previous or current malignancies, treatment with immunomodulatory agents, and use of drugs with potential interactions with prescribed drugs. Eligible patients were centrally randomized (1:1) to initiate dolutegravir (50 mg) plus tenofovir alafenamide/emtricitabine (25/200 mg) or a single tablet of dolutegravir/lamivudine (50/300 mg) once daily. The study was carried out according to the principles of the Declaration of Helsinki. It was approved by the Spanish Agency for Medicines and Healthcare Products and the Ethics Committee for Research on Medicinal Products of Seville (record# 02/2020). All participants provided signed informed consent."