December 20, 2016
The primary endpoint of noninferiority was met in two phase 3 trials evaluating the safety and efficacy of switching virologically suppressed patients with HIV from a three- or four-drug ART regimen to a two-drug regimen containing Tivicay and Edurant, according to ViiV Healthcare.
The investigational regimen of Tivicay (dolutegravir, ViiV Healthcare) and Edurant (rilpivirine, Janssen Therapeutics), provided as individual tablets, was assessed in the SWORD-1 and SWORD-2 phase 3 trials. The trials are replicate 148-week, randomized, open-label studies that compare the antiviral activity and safety of dolutegravir/rilpivirine with current ART therapy.
The trials’ primary endpoints are the proportion of patients with plasma HIV-1 RNA less than 50 copies/mL at week 48. Secondary endpoints include the incidence of viral resistance, safety and tolerability measurements, and changes in renal, bone and cardiovascular biomarkers. Researchers also are investigating changes in health-related quality of life and the willingness among HIV patients to switch and adhere to treatment regimens.
Additional details on the results will be presented at an upcoming scientific conference, according to a press release.
“These are important results for the HIV scientific community and represent an important milestone in our understanding of how HIV can be treated,” Dominique Limet, CEO of ViiV Healthcare, said in the release. “The results support our strategy of investigating two-drug regimens as innovative treatment options for people living with HIV and we are planning regulatory submissions for this two-drug regimen as a single tablet in 2017.”
Disclosure: Limet is an employee of ViiV Healthcare.