A lot of new and hopeful information was shared at the 9th International AIDS Society Conference on HIV Science this week in Paris, France. One exciting announcement for those living with HIV is regarding the development of a new one-pill treatment regimen.
Tuesday at the conference, pharmaceutical company Janssen (owned by Johnson & Johnson) released the results of a major trial study which tested a new darunavir-based, single-tablet treatment for HIV. In completing Phase 3 of the EMERALD trial, researchers concluded that this new single-tablet regimen (STR) “is effective and well-tolerated.” This is especially great news considering the World Health Organization’s recently released report about the growing global threat of drug-resistant HIV.
“The complexity and high pill burden of some HIV treatment regimens can result in non-adherence, which is one of the major contributors to the development of HIV drug resistance,” said Professor Jean-Michel Molina, Professor of Infectious Diseases at the University of Paris Diderot, in a press release this week.
The once-daily pill contains 800 mg of darunavir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide [D/C/F/TAF]. Results from Phase 3 of the study showed that the treatment had “a low cumulative virologic rebound rate and a high virologic suppression rate at 24 weeks in HIV virologically suppressed adults who switched from a standard boosted protease inhibitor (PI) regimen.” In simpler terms, it was effective in quickly suppressing HIV, and the virus didn’t exhibit any signs of resistance to this treatment.
The 48-week study’s key focus was “to evaluate the efficacy and safety” of switching patients from a boosted protease inhibitor plus emtricitabine-tenofovir (PI plus F/TDF) regimen, to the new D/C/F/TAF one-pill regimen. At Week 24, virologic suppression was seen in 96.3 percent of patients, and virologic failure occurred in 0.5 percent of patients, “with no discontinuations for virologic failure and no detected resistance to any study drug.”
“These promising results show that the darunavir-based STR was highly effective and well tolerated, providing a complete treatment regimen with a high genetic barrier to resistance with just one single daily tablet,” said Molina. “If we can help to reduce the treatment burden for patients living with HIV-1, this can help to improve adherence which we know is essential for achieving viral suppression and reducing the emergence of resistance mutations.”