Two-Drug HIV Combo as Effective as Three-, Four-Drug Regimen in Phase 3 Studies
Janssen announced positive data from the SWORD Clinical Trial Program of the two-drug regimen dolutegravir (ViiV Healthcare) and rilpivirine (Janssen) for the maintenance treatment of HIV-1 infection in patients who have already achieved viral suppression.
The SWORD clinical program consisted of two randomized, 148-week, open-label, non-inferiority Phase 3 studies (SWORD 1 and SWORD 2) evaluating the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine (DTG+RPV) 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 primary endpoint was the proportion of patients with plasma HIV-1 RNA <50c/mL at Week 48. Key secondary endpoints included evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. Additional measures including assessment of change in health-related quality of life, willingness to switch, and treatment adherence were also evaluated.
Both studies showed that switching to the two-drug regimen of dolutegravir and rilpivirine is as effective as three- or four-drug regimen as maintenance therapy in patients who have already achieved viral suppression. Treatment with DTG+RPV achieved non-inferior viral suppression (HIV-1 RNA <50c/mL) at 48 weeks compared to current antiretroviral therapy (CAR) [adjusted difference –0.2%, (95% CI: [3.0%, 2.5%]), pooled analysis]. Additionally, virologic failure rates were <1% in the DTG+RPV arm and 1% in the three- or four- antiretroviral-drug arm.
The safety profile for the DTG+RPV regimen was consistent with each drug's product labeling, with the most common adverse events such as nasopharyngitis, headache, diarrhea and upper respiratory tract infection. The overall rate of serious adverse events was comparable between treatment groups (DTG+RPV: 27, CAR: 21).
Detailed results of the trials were presented at the Annual Conference on Retroviruses and Opportunistic Infections (CROI).
Dolutegravir, currently marketed as Tivicay, is an HIV-1 integrase strand transfer inhibitor (INSTI) while rilpivirine, marketed as Edurant, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
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