A two-drug regimen consisting of once-daily dolutegravir-rilpivirine is effective for maintaining HIV suppression and demonstrates safety similar to that of routine antiretroviral therapy (ART), according to a 48-week, placebo-controlled, randomized trial published in Lancet.
In 2 randomized, non-inferiority, multicenter trials (SWORD-1 and SWORD-2), investigators compared patients with HIV randomly assigned to either 50 mg dolutegravir and 25 mg rilpivirine once a day (n=516) vs current ART (n=512) to determine the differences between the 2 regimens in terms of safety and efficacy. The primary end point, evaluated at 48 weeks of treatment, was the number of patients who had a viral load <50 copies/mL.
Investigators performed a pooled analysis of the intention-to-treat population and found that both the once-daily dolutegravir-rilpivirine group (n=513) and current ART (n=511) group had similar proportions of patients who achieved the primary end point (95% for both; adjusted treatment difference, -0.2%; 95% CI -3.0 to 2.5).
Approximately 77% (n=395) and 71% (n=364) of participants in the dolutegravir-rilpivirine group and current ART group, respectively, reported adverse events with their treatment regimen. A higher proportion of participants in the dolutegravir-rilpivirine cohort (3%) experienced adverse events that led to discontinuation compared with those receiving current ART (1%).
Because physicians and patients may have had knowledge of their treatment prior to entering this open-label trial, the study may have been susceptible to bias. Additionally, both of the studies used in this analysis did not include participants from lower economic nations, potentially limiting the generalizability of the findings.
This study highlights the utility of polypharmacy in HIV and suggests that, “treatment simplification strategies with two-drug regimens such as dolutegravir-rilpivirine might become more prominent in treatment decisions.”
Disclosure: This study was funded by ViiV Healthcare and Janssen Pharmaceutica NV.
Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies [published online January 5, 2018]. Lancet. doi: 10.1016/S0140-6736(17)33095-7