Efficacy, safety and tolerability of dolutegravir-based combination antiretroviral therapy in clinical practice in HIV-infected patients: results from a multicenter study

Objective: Dolutegravir (DTG) is a second-generation integrase inhibitor (INI) characterized by unboosted daily dosing, limited cross resistance, and a high barrier to resistance. We aimed to describe the efficacy and safety of DTG-based cART in clinical practice in both naïve and experienced HIV1-infected patients. Patients and Methods: We performed an observational, retrospective, multi-center study. From 2015, all patients starting a new cART regimen containing DTG were enrolled. Clinical and virological details, together with pharmacological history were collected from each patient. Results: Of 210 patients included in the analysis, 157 (74.8%) were males, 185 (87.6%) Caucasians, 43 (20.5%) were co-infected with hepatitis C and 67 (31.9%) had been previously diagnosed as CDC stage C. At baseline, 97 (46.2%) patients had a positive HIV-RNA, of which 43 (20.5%) were ART-naïve subjects. The mean age at enrollment was 47.7±12.2 years, with a median CD4+ count of 453 (IQR 270-693) cells/mm3. Among naïve patients, 34/41 (82.9%) resulted virologically suppressed at 3 months, 23/26 (88.5%) at 6 and 15/17 (88.2%) at 12 months, with an increase in CD4+ count. Among experienced viremic patients, 27/44 (61.4%) resulted virologically suppressed at 3 months, 29/33 (87.9%) and 21/26 (80.8%) respectively at 6 and 12 months, with an increase in CD4+ count. Among experienced patients with suppressed HIV-RNA, 102/109 (93.6%) kept virological suppression at 3 months, 87/93 (93.5%) at 6 and 66/71 (93%) at 12 months. There were only 14 (6.6%) interruptions, 12(5.7%) due to adverse events. There was a significant increase in creatinine levels, whereas no statistically significant changes were observed in lipid or hepatic profile. Conclusions: Our data confirm the high potency of DTG in a HIV-infected naive and experienced patient population. We also evidenced very rapid CD4 cells increase after only 3 months. Our results also highlight the good tolerability of DTG-based