Gilead Sciences has announced results supporting Biktarvy as a highly effective treatment for people with HIV, including those with HIV and hepatitis B (HBV) co-infection.
Biktarvy is a complete HIV treatment, combining three medicines to form the smallest three-drug, single-tablet regimen (STR) available, as a simple once-daily dosing regimen. It also has a limited drug interaction potential and a high barrier to resistance.
The ALLIANCE trial – an ongoing phase 3 study – provided interim data assessing Biktarvy in adult patients with HIV/HBV co-infection who were starting therapy, which showed the potential suppression of HBV and HIV suppression when compared to an alternative HIV regimen.
The multicentre ALLIANCE trial involved participants over four years from Europe, Asia and North and Latin America. Further results from the trial showed that participants who initiated treatment with Biktarvy had numerically higher hepatitis B surface antigen (HBsAg) loss, HBeAg loss and alanine aminotransferase (ALT) normalisation.
The data was presented at the 24th International AIDS Conference (AIDS 2022) and the five-year cumulative data showed that no cases of treatment failure due to emergent resistance were identified in the analysis of five years of data from both studies. This bolsters the efficacy and tolerability profile of Biktarvy as a treatment for adult HIV patients with no prior antiretroviral therapy history.
Jared Baeten, vice president, HIV clinical development, Gilead Sciences, said: “The HIV treatment research data presented at the 24th International AIDS Conference is an important step in deepening our understanding of how to support the long-term and overall health of a broad range of people with HIV worldwide.”
In addition, the results taken from the pooled analysis of the two phase 3 trials, study 1489 and study 1490, showed that 99% of participants who began treatment with Biktarvy and remained in the study for all 240 weeks achieved and maintained an undetectable viral load for five years of follow-up.
HIV/HBV co-infection is a serious global public health concern, which increases the morbidity and mortality beyond either infection alone, with HBV impacting approximately 8% of people with HIV worldwide, while HIV/HBV co-infection rates can reach 25% in areas where both viruses are endemic, such as Asia.
In certain parts of Asia, HBV is endemic with a projected 70% of the population showing serologic evidence of current or prior infection. Due to each virus affecting the other’s natural history and response to therapy, HIV/HBV co-infection requires committed research. There is currently no cure for HIV or AIDS.