PMID- 29588457 OWN - NLM STAT- MEDLINE DCOM- 20191007 LR - 20240314 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 8 IP - 1 DP - 2018 Mar 27 TI - Efficacy and safety of boosted darunavir-based antiretroviral therapy in HIV-1-positive patients: results from a meta-analysis of clinical trials. PG - 5288 LID - 10.1038/s41598-018-23375-6 [doi] LID - 5288 AB - Darunavir/ritonavir (DRV/r) is a second-generation protease inhibitor used in treatment-naive and -experienced HIV-positive adult patients. To evaluate efficacy and safety in these patient settings, we performed a meta-analysis of randomized controlled trials. We considered eight studies involving 4240 antiretroviral treatment (ART)-naive patients and 14 studies involving 2684 ART-experienced patients. Regarding efficacy in the ART-naive patients, the virological response rate was not significantly different between DRV/r and the comparator. For the ART-experienced failing patients, the virological response rate was significantly higher with DRV/r than with the comparator (RR 1.45, 95% CI: 1.01-2.08); conversely, no significant differences were found between the treatment-experienced and virologically controlled DRV/r and comparator groups. Regarding safety, the discontinuation rates due to adverse events (AEs) and DRV/r-related serious adverse events (SAEs) did not significantly differ from the rates in the comparator group (RR 0.84, 95% CI: 0.59-1.19 and RR 0.78, 95% CI: 0.57-1.05, respectively). Our meta-analysis indicated that DRV/r-based regimens were effective and tolerable for both types of patients, which was consistent with published data. FAU - Antinori, A AU - Antinori A AD - HIV/AIDS Department, National Institute for Infectious Diseases "Lazzaro Spallanzani" IRCCS, Roma, Italy. FAU - Lazzarin, A AU - Lazzarin A AD - Department of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy. FAU - Uglietti, A AU - Uglietti A AD - Janssen-Cilag SpA, Medical Affairs Department, Infectious Diseases, Cologno Monzese, (MI), Italy. FAU - Palma, M AU - Palma M AD - Janssen-Cilag SpA, Medical Affairs Department, Infectious Diseases, Cologno Monzese, (MI), Italy. FAU - Mancusi, D AU - Mancusi D AD - Janssen-Cilag SpA, Medical Affairs Department, Infectious Diseases, Cologno Monzese, (MI), Italy. dmancusi@its.jnj.com. FAU - Termini, R AU - Termini R AD - Janssen-Cilag SpA, Medical Affairs Department, Infectious Diseases, Cologno Monzese, (MI), Italy. LA - eng PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't DEP - 20180327 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 0 (HIV Protease Inhibitors) RN - O3J8G9O825 (Ritonavir) RN - YO603Y8113 (Darunavir) SB - IM MH - Darunavir/adverse effects/*therapeutic use MH - HIV Infections/*drug therapy MH - HIV Protease Inhibitors/adverse effects/*therapeutic use MH - HIV-1/*drug effects MH - Humans MH - Randomized Controlled Trials as Topic MH - Ritonavir/adverse effects/*therapeutic use MH - Treatment Outcome MH - Viral Load/drug effects PMC - PMC5869729 COIS- Andrea Antinori (A.A.) has received honoraria for consultancies with Gilead Sciences, ViiV Healthcare, Merck Sharp & Dohme, Janssen-Cilag, Abbvie, and Bristol-Myers Squibb and has also received research grants from Gilead Sciences, Bristol-Myers Squibb, Janssen-Cilag, and ViiV Healthcare; Adriano Lazzarin (A.L.) has received fees for advisory board participation and conference talks from BMS, ViiV, Gilead, MSD, Mylan, Abbvie, Janssen Cilag, and Teva; Alessia Uglietti (A.U.), Maria Palma (M.P.), Daniela Mancusi (D.M.) and Roberta Termini (R.T.) are employees of Janssen-Cilag SpA, Italy. EDAT- 2018/03/29 06:00 MHDA- 2019/10/08 06:00 PMCR- 2018/03/27 CRDT- 2018/03/29 06:00 PHST- 2017/09/25 00:00 [received] PHST- 2018/03/12 00:00 [accepted] PHST- 2018/03/29 06:00 [entrez] PHST- 2018/03/29 06:00 [pubmed] PHST- 2019/10/08 06:00 [medline] PHST- 2018/03/27 00:00 [pmc-release] AID - 10.1038/s41598-018-23375-6 [pii] AID - 23375 [pii] AID - 10.1038/s41598-018-23375-6 [doi] PST - epublish SO - Sci Rep. 2018 Mar 27;8(1):5288. doi: 10.1038/s41598-018-23375-6.