Cohort profile: The Observational cohort for the study of DOlutegravir in Antiretroviral Combination REgimens (ODOACRE)

The Observational cohort for the study of DOlutegravir in Antiretroviral Combination REgimens (ODOACRE) cohort was established in Italy in 2016 to evaluate the overall efficacy and tolerability of dolutegravir (DTG)-based antiretroviral (ARV) regimens in clinical practice

A comparison between two dolutegravir-based two-drug regimens as switch strategies in a multicentre cohort of HIV-1-infected patients

BACKGROUND: Two-drug regimens are increasingly used in clinical practice as switch strategies. We compared the efficacy and safety of two dolutegravir-based dual therapies (DT): dolutegravir plus lamivudine (3TC group) versus DTG plus rilpivirine (RPV group). METHODS: In a multicenter cohort of virologically suppressed (HIV-RNA <50 cp/ml) HIV+ pts switching to DTG+3TC or DTG+RPV we analyzed the incidence of virological failures (VF) and treatment discontinuations (TD), as well as their predictors. RESULTS: We analyzed 416 pts, 229 in the 3TC group and 187 in the RPV group. The 3TC group, during 344.4 person-years of follow-up (PYFU), had 10 VF without the emergence of resistance mutations, while 30 pts discontinued the regimen. In the RPV group, during 371.0 PYFU, there were 5 VF (one developed NNRTI-mutations Y181C and E138Q) and 13 TD. The estimated probability of remaining free from VF at 48 weeks showed no significant difference between groups (log-rank 0.172). We found a higher risk of VF in patients with peak VL>500000cp/ml in both treatment groups (log-rank p=0.004 in each group). The estimated probability of remaining in the study regimen at week 48 was 89.0% with DTG+3TC and 96.1% with DTG+RPV (log-rank 0.015). After adjusting for potential confounders, treatment group was not associated to TD. A significant decrease in total cholesterol was observed at week 48 in both groups while renal function remained unchanged. CONCLUSIONS: DTG+RPV and DTG+3TC were compared in populations with different characteristics in clinical practice: both regimens showed good effectiveness and improved lipid profile