The SWORD-1 and-2 trials are identical 148-week, randomized, open-label, non-inferiority studies to assess the antiviral activity and safety of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three- or four-drug regimen.

The dolutegravir and rilpivirine regimen achieved non-inferior viral suppression (HIV-1 RNA <50 copies/mL, the primary endpoint) at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses: current antiretroviral therapy (CAR) 485/511 (95%), dolutegravir + rilpivirine 486/513 (95%) [adjusted difference -0.2% (95% CI: 3.0%, 2.5%%], pooled analysis]).

Virologic failure rates were <1% in the dolutegravir/rilpivirine arm and 1% in the three- or four- antiretroviral-drug arm. No integrase strand inhibitor (INSTI) resistance-associated mutations were reported. Protocol-defined virologic failure with a non-nucleoside reverse-transcriptase inhibitor (NNRTI) resistance-associated mutation (RAMs, K101K/E) was reported in only one patient in the dolutegravir/rilpivirine arm in the context of documented non-adherence, but with no impact on regimen efficacy as the subject re-suppressed on dolutegravir and rilpivirine before withdrawal from the study.

The overall number of serious adverse events was comparable between treatment groups at 27 patients for dolutegravir/rilpivirine and 21 for CAR. As expected when switching from a stable regimen to a new regimen, more adverse events were reported and led to withdrawal from the study in the DTG+RPV arm, 21 vs. 3 for CAR. The safety profiles for dolutegravir and rilpivirine in these studies were consistent with their product labels.

ViiV/Janssen's Double-Edged SWORD: Four Drugs Good, Two Drugs Better?

More from Clinical Trials

More from R&D