Gilead Sciences has reported positive three-year data from two Phase III clinical trials of Biktarvy in adults with human immunodeficiency virus-1 (HIV-1) infection.
Biktarvy is a combination of 50mg bictegravir, 200mg emtricitabine and 25mg tenofovir alafenamide.
The randomised, double-blind, active-controlled Study 1489 and Study 1490 trials assessed the drug in 1,274 treatment-naïve patients.
Primary endpoint was virologic suppression determined as the proportion of patients who were virologically suppressed at week 48. Both trials met the primary endpoint with non-inferior efficacy.
The latest three-year data showed that Biktarvy was well-tolerated, with high virologic suppression rates to week 144 when compared to dolutegravir (DTG)-containing regimens.
The non-inferior efficacy was maintained at week 144 in both trials. Gilead noted that a similar proportion of patients across all treatment groups experienced virologic suppression.
Investigators did not report any treatment failure due to treatment-emergent resistance. Adverse events-related discontinuations were observed to be low across all groups.
After week 144, patients will have the option for treatment with Biktarvy for up to 96 weeks in an open-label extension.
Gilead Sciences HIV and Emerging Viruses senior vice-president Diana Brainard said: “The findings presented today support the value of Biktarvy as an effective treatment that offers durable viral suppression and maintains a high barrier to resistance.
“These longer-term data reaffirm Biktarvy’s role as a first-line treatment option for appropriate adults who are living with HIV and are starting therapy.”
The company also reported positive results for its Descovy (200mg emtricitabine and 25mg tenofovir alafenamide), which is intended for HIV pre-exposure prophylaxis (PrEP).
During a global Phase III registrational trial, named DISCOVER, Descovy showed non-inferior efficacy to Truvada (200mg emtricitabine and 300mg tenofovir disoproxil fumarate) to 96 weeks.