'With age comes wisdom': effectiveness and tolerability of dolutegravir + lamivudine in virologically-suppressed people with HIV.

OBJECTIVES

Results from clinical trials and observational studies suggest that dolutegravir plus lamivudine is a well tolerated option for simplification in people with HIV (PWH). We aimed to assess long-time effectiveness and safety in our cohort.

METHODS

We performed an observational study enrolling HIV-1-infected, virologically suppressed PWH, switching to dolutegravir plus lamivudine. Exclusion criteria were HBV-coinfection and the presence of the M184V mutation before the simplification. We performed survival analysis to evaluate time to virological failure (VF, defined by a single HIV-RNA ≥200 copies/ml or by two consecutive HIV-RNA ≥ 50 copies/ml) and treatment discontinuation (TD, defined as the interruption of either 3TC or DTG).

RESULTS

Six hundred thirty-one PWH were considered for the analysis: 446 were males (70.7%), with a median age of 51.1 years [interquartile range (IQR) 42.6-57.6]. Estimated probabilities of maintaining virological suppression at 192 and 384 weeks were 95.1% [95% confidence interval (CI) 92.0-96.2] and 91.5% (95% CI 87.1-94.4), respectively. At multivariable analysis, including zenith HIV-RNA, time of virological suppression before switch, risk factors for HIV infection and age, only intravenous drug users (IDU) [versus other risk factors, adjusted hazard ratio (aHR) 3.58, 95% CI 1.38-9.28, P  = 0.009] independently predicted VF. A border-line significant association with VF emerged for age (per 10-years more, aHR 0.72, 95% CI 0.51-1.01, P  = 0.058) and zenith HIV-RNA >500 000 cps/ml (versus. <500 000 cps/ml, aHR 2.31, 95% CI 0.98-5.46, P  = 0.056).As to treatment tolerability, estimated probabilities of remaining on study regimen at 192 and 384 weeks were 87.8% (95% CI 84.5-90.5) and 85.1% (95% CI 81.0-88.5), respectively.

CONCLUSIONS

Our findings confirm the long-term effectiveness and tolerability of dolutegravir plus lamivudine in virologically suppressed PWH.