Llibre JM, et al. - Researchers designed this trial in order to contemplate the safety, tolerability, and efficacy of dolutegravir and rilpivirine as a two-drug regimen in adults with HIV-1. In enrollees with HIV suppression, dolutegravir-rilpivirine was discovered to be non-inferior to current antiretroviral therapy (ART) regimen [CAR] over 48 weeks. Findings illustrated a safety profile consistent with its components. Hence, the yielded data supported the use of this two-drug regimen for the maintenance of HIV suppression.

Methods

• The SWORD-1 and SWORD-2 trials were open-label, parallel-group, multicentre, phase 3, randomised, non-inferiority studies conducted in 12 countries.
• Experts analyzed the efficacy and safety of once-daily dolutegravir 50 mg plus rilpivirine 25 mg vs current ART regimen (CAR).
• The enrollment consisted of patients aged 18 years or older who were on first or second ART with stable plasma HIV-1 RNA (viral load <50 copies per mL) for 6 months or longer at screening.
• Enrollees were randomly allocated (1:1) with stratification by third-agent class, age, and planned participation in a bone mineral density substudy.
• The proportion of participants with the viral load lower than 50 copies per mL at week 48 among those individuals who received one or more doses of study medication constituted the primary endpoint.
• Adverse events were monitored in order to gauge the safety profile.

Results

• Screening was undertaken for subjects from April 14, 2015, to Oct 15, 2015, for SWORD-1 and from April 21, 2015, to Sept 25, 2015, for SWORD-2.
• A total of 516 subjects were allocated to dolutegravir-rilpivirine and 512 to continue with CAR.
• At week 48 (last patient visit was Nov 22, 2016), 95% of the candidates reported lower viral loads than 50 copies per mL in each group (486 of 513 in the dolutegravir-rilpivirine group vs 485 of 511 in the CAR group), with an adjusted treatment difference of -0·2% (95% CI -3·0 to 2·5), in the pooled analysis of the intention-to-treat population.
• They exhibited non-inferiority with a predefined margin of -8%.
• Researchers reported the presence of adverse events in 395 (77%) of the 513 candidates in the dolutegravir-rilpivirine group and 364 (71%) of the 511 subjects in the CAR group.
• It was determined that nasopharyngitis (49 [10%] for dolutegravir-rilpivirine vs 50 [10%] for CAR) and headache (41 [8%] vs 23 [5%]) were the most common adverse events.
• Adverse events were detected in more subjects taking dolutegravir-rilpivirine (17 [3%]), thereby leading to withdrawal when compared to candidates taking CAR (three [<1%]).