Detailed phase III results presented for Edurant (dolutegravir) and Tivicay (rilpivirine) in HIV treatment- ViiV Healthcare and Janssen

ViiV Healthcare and Janssen announced detailed study results from its phase III programme evaluating the safety and efficacy of switching virologically suppressed patients from a three- or four-drug antiretroviral regimen to a two-drug regimen of Edurant (dolutegravir) and Tivicay (rilpivirine) in HIV treatment. The dolutegravir and rilpivirine regimen achieved non-inferior viral suppression (HIV-1 RNA <50 copies/millilitre) at 48 weeks compared with a three- or four-drug regimen in both pooled and individual analyses of the SWORD 1 and SWORD 2 studies (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 suppression rates were similar between treatment arms. The median duration of antiretroviral treatment was just over four years at the time of entry into the studies.

The most commonly reported (>5%) adverse events in the dolutegravir and rilpivirine arm were nasopharyngitis, headache, diarrhoea and upper respiratory tract infection. For the CAR arm, the most commonly reported adverse events were nasopharyngitis, upper respiratory tract infection, back pain, headache and diarrhoea. The studies are ongoing for 148 weeks. Virologic failure rates were <1% in the dolutegravir and rilpivirine arm and 1% in the three- or four- antiretroviral-drug arm. No INSTI resistance-associated mutations were reported. The overall rate of serious adverse events was comparable between treatment groups (dolutegravir + rilpivirine: 27, CAR: 21).

As would be 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 dolutegravir and rilpivirine arm compared to the CAR arm (dolutegravir + rilpivirine: 21, CAR: 3). The safety profiles for dolutegravir and rilpivirine in these studies were consistent with the product labelling for each medicine.

Headline results were announced in December 2016 and detailed study results are being presented at the annual Conference on Retroviruses and Opportunistic Infections in Seattle.