PMID- 27661787 OWN - NLM STAT- MEDLINE DCOM- 20180326 LR - 20201209 IS - 2040-2058 (Electronic) IS - 1359-6535 (Linking) VI - 22 IP - 3 DP - 2017 TI - Salvage therapy or simplification of salvage regimens with dolutegravir plus ritonavir-boosted darunavir dual therapy in highly cART-experienced subjects: an Italian cohort. PG - 257-262 LID - 10.3851/IMP3095 [doi] AB - BACKGROUND: Dolutegravir plus darunavir provide a high genetic barrier to HIV-1 resistance and are suitable for simple salvage regimens. METHODS: All HIV-1-infected subjects treated with dolutegravir plus boosted darunavir dual therapy between March 2011 and September 2015 were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48. RESULTS: We enrolled 113 subjects. After week 24, one was lost at follow-up, one dropped out for grade 2 elevation of liver enzymes, one died from illicit drug abuse and one from cancer-related sepsis. The mean age was 51, 26.5% were female and 9.7% were non-Caucasian. Twenty had never experienced failure. A total of 99 had reverse-transcriptase (RT) mutations, 87 had protease inhibitor mutations and 12 had integrase strand transfer inhibitor (INSTI) mutations. Viraemic patients declined from baseline to week 24 from 43.4% to 6.2%, the remainder being due to high baseline viraemia or adherence issues. The proportion of subjects with viraemia 1-49 copies/ml remained at 20.4% while those in whom no virus was detected (NVD) increased from 36.3% to 73.5% by week 24. All the 47 subjects who had a 48-week follow-up had <50 copies/ml and 42 (89.4%) had NVD. 18 subjects had reduced sensitivity to darunavir (Stanford median score 15, range 15-40), but none rebounded, 6 having a 24-week and 7 a 48-week follow-up. The median variation in serum creatinine was -0.01 (range +0.2 to -0.21) mg/dl. CONCLUSIONS: This dual regimen provides a simple salvage regimen and proved safe and effective in this cohort. FAU - Capetti, Amedeo F AU - Capetti AF AD - 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy. FAU - Sterrantino, Gaetana AU - Sterrantino G AD - Division of Infectious Diseases, 'Careggi' Hospital, Florence, Italy. FAU - Cossu, Maria V AU - Cossu MV AD - 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy. FAU - Cenderello, Giovanni AU - Cenderello G AD - Division of Infectious Diseases, Ospedali Galliera, Genoa, Italy. FAU - Cattelan, Anna M AU - Cattelan AM AD - Division of Infectious and Tropical Diseases, Azienda Ospedaliera-Universitaria di Padova, Padua, Italy. FAU - De Socio, Giuseppe V AU - De Socio GV AD - Infectious Diseases Clinic, Azienda Ospedaliero-Universitaria di Perugia, Perugia, Italy. FAU - Rusconi, Stefano AU - Rusconi S AD - Infectious Diseases Clinic, ASST Fatebenefratelli-Sacco, Milan, Italy. FAU - Riccardi, Niccolo AU - Riccardi N AD - Infectious Diseases Clinic, 'San Martino' Hospital, Genoa, Italy. FAU - Baldin, Gian M AU - Baldin GM AD - 2nd Division of Infectious Diseases, 'Policlinico Universitario Agostino Gemelli' Hospital, Rome, Italy. FAU - Cima, Serena AU - Cima S AD - 2nd Division of Infectious Diseases, 'Policlinico San Matteo' Hospital, Pavia, Italy. FAU - Niero, Fosca P AU - Niero FP AD - 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy. FAU - Rizzardini, Giuliano AU - Rizzardini G AD - 1st Division of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy. FAU - Sasset, Lolita AU - Sasset L AD - Division of Infectious Diseases, 'Santa Maria della Misericordia' Hospital, Rovigo, Italy. LA - eng PT - Journal Article DEP - 20160923 PL - England TA - Antivir Ther JT - Antiviral therapy JID - 9815705 RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Oxazines) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - 0 (RNA, Viral) RN - DKO1W9H7M1 (dolutegravir) RN - O3J8G9O825 (Ritonavir) RN - YO603Y8113 (Darunavir) SB - IM EIN - Antivir Ther. 2017;22(3):273-275. PMID: 28400541 MH - Adult MH - Aged MH - Aged, 80 and over MH - Antiretroviral Therapy, Highly Active MH - Cohort Studies MH - Darunavir/*therapeutic use MH - Drug Resistance, Viral MH - Drug Substitution MH - Female MH - HIV Infections/*drug therapy/*virology MH - HIV-1/*drug effects/genetics MH - Heterocyclic Compounds, 3-Ring/*therapeutic use MH - Humans MH - Italy MH - Male MH - Middle Aged MH - Mutation MH - Oxazines MH - Piperazines MH - Pyridones MH - RNA, Viral MH - Retreatment MH - Ritonavir/*therapeutic use MH - Salvage Therapy MH - Viral Load MH - Virus Replication/drug effects MH - Young Adult EDAT- 2016/09/24 06:00 MHDA- 2018/03/27 06:00 CRDT- 2016/09/24 06:00 PHST- 2016/09/21 00:00 [accepted] PHST- 2016/09/24 06:00 [pubmed] PHST- 2018/03/27 06:00 [medline] PHST- 2016/09/24 06:00 [entrez] AID - 10.3851/IMP3095 [doi] PST - ppublish SO - Antivir Ther. 2017;22(3):257-262. doi: 10.3851/IMP3095. Epub 2016 Sep 23.