Abstract and Introduction
Background: Results from clinical trials and observational studies suggest that dolutegravir plus lamivudine could be an effective and well-tolerated option for simplification in HIV-1–positive patients. We aimed to assess long-time efficacy and safety in our multicenter cohort.
Methods: This was a retrospective study enrolling HIV-1–infected, virologically suppressed patients switching to dolutegravir + lamivudine. We performed survival analysis to evaluate time to virological failure (VF, defined by a single HIV-RNA ≥1000 copies/mL or by 2 consecutive HIV-RNA ≥ 50 copies/mL) and treatment discontinuation (defined as the interruption of either 3TC or dolutegravir), assessing predictors via Cox regression analyses.
Results: Seven-hundred eighty-five patients were considered for the analysis: 554 were men (70.6%), with a median age of 52 years (interquartile range 45–58 years). Estimated probabilities of maintaining virological suppression at weeks 96, 144, and 240 were 97.7% (SD ±0.6), 96.9% (SD ±0.8), and 96.4% (SD ±0.9), respectively. A non-B HIV subtype (P = 0.014) and a previous VF (P = 0.037) resulted predictors of VF. We did not observe differences in probability of VF in people living with HIV with an M184V resistance mutation (P = 0.689); however, in a deeper analysis, M184V mutation was a predictor of VF (P = 0.038) in patients with time of virological suppression <88 months. Estimated probabilities of remaining on study regimen at 96, 144, and 240 weeks were 82.9% (SD ±1.4), 79.7% (SD ±1.6) and 74.3% (SD ±2.2), respectively.
Conclusions: Our findings show the long-term efficacy and tolerability of dolutegravir plus lamivudine in virologically suppressed patients.
In the last decade, less-drug regimens, mainly 2-drug regimens (2DRs), have been widely regarded as a plausible alternative to standard 3-drug regimens in virologically suppressed people living with HIV (PLWHIV), in particular in situations where data on preswitch resistance mutations are available. The rationale of 2DR strategies lies in the expected better tolerability and safety profile without sacrificing the virological efficacy.[2,3] Lamivudine (3TC)-based 2DRs have been among the most studied switch strategies in latest years; clinical trials and observational studies analyzed the efficacy, safety, and tolerability of several 2DRs with 3TC and a boosted protease inhibitor.[3–6] Since the introduction of second-generation integrase inhibitor (INI) dolutegravir (DTG), real-life reports emerged, describing the high efficacy and good tolerability profile of a 2DR with DTG + 3TC.[7–9] Recently, the TANGO study, a randomized clinical trial, has been published, highlighting that a 2DR of DTG + 3TC was noninferior in maintaining virological suppression compared with a TAF-based 3-drug regimen. In a previous work, a reply to the authors of the TANGO study, we observed that there were nonsignificant differences between patients who met the TANGO inclusion criteria and those who did not, in our multicenter cohort, showing that the analyzed regimen could be effective and safe on an even larger scale. The goal of the present study, 5 years after switching our first treatment-experienced patients to DTG + 3TC, was to investigate the long-term efficacy and safety of DTG + 3TC in a multicenter real-life observational cohort of adult PLWHIV.
J Acquir Immune Defic Syndr. 2021;88(3):234-237. © 2021 Lippincott Williams & Wilkins