Gilead Sciences Inc. said its triple combination therapy containing bictegravir met its primary endpoint in a phase 3 trial for treating HIV-1 infected adult patients.
The company's triple therapy consists of bictegravir, an integrase strand transfer inhibitor, as well as nucleoside reverse transcriptase inhibitors, emtricitabine and tenofovir alafenamide.
The study showed that the combination was statistically noninferior in treating virologically suppressed HIV-1 infected patients after they were switched from boosted protease inhibitor, or bPI, based regimens.
Virological suppression occurs after a patient's viral load is reduced to an undetectable level with the help of an antiretroviral therapy.
The study, named 1878, involved 577 patients taking bPI regimen of boosted atazanavir or darunavir plus abacavir/lamivudine or emtricitabine/tenofovir disoproxil fumarate, who were later randomized to continue their regimen or switch to the triple combination therapy.
According to the results, 92.1% of patients on the triple therapy reported HIV-1 RNA levels of less than 50 copies per milliliter compared to 88.9% patients in the bPI arm.
None of the patients given the single tablet combination developed resistance to the treatment through 48 weeks of the study.
The company reported topline results from 1878 study in May along with results from three other phase 3 studies evaluating the triple therapy.
Two of the studies compared the combination with regimens containing GlaxoSmithKline plc's dolutegravir, among patients new to treatment, and the third tested it among virologically suppressed patients switching from another anti-retroviral regimen.
Gilead Sciences filed a new drug application in June with the U.S. Food and Drug Administration, which is expected to make a decision on the therapy by Feb. 12, 2018.
The results from 1878 study along with three other studies suggest that the triple therapy may be appropriate for a broad range of HIV patients, said Eric Daar, lead author of 1878 and chief of HIV division at Los Angeles Biomedical Research Institute.