Gilead Sciences Inc.'s single-tablet treatment for HIV-1, Biktarvy, worked as well as certain antiviral and antiretroviral drugs in a phase 3 study of women with HIV.
The ongoing study, called Study 1961, tested the efficacy and safety of switching from a boosted protease inhibitor, or bPI, or boosted elvitegravir-containing regimen to Biktarvy in 470 adult women whose viral levels were suppressed.
Protease inhibitors are a class of antiviral drugs. Elvitegravir is an antiretroviral drug marketed by Gilead as a single pill formulation under the trade name Vitekta. Antiretroviral drugs are medications that do not kill or cure the HIV virus but can slow down or prevent the growth of the virus.
Virological suppression is reached when the level of HIV in the blood is very low and undetectable, but it does not mean that the patient is cured.
The data was presented at the International Workshop on HIV and Women and at the 2018 Conference on Retroviruses and Opportunistic Infections in Boston.
The women in the study were taking a regimen of either Gilead's Genvoya or Stribild, or Bristol-Myers Squibb Co.'s Reyataz, AbbVie Inc.'s Norvir and emtricitabine/tenofovir disoproxil fumarate. They were randomized 1:1 to switch to Biktarvy or stay on their baseline regimen.
Study 1961 showed that Biktarvy was statistically noninferior to treatments containing a bPI or boosted elvitegravir and that the women had not developed a resistance to the treatment at 48 weeks into the study.
At week 48, 1.7% of participants in both groups had an amount of HIV-1 in their system that was higher than 50 viral copies per milliliter. In the Biktarvy group, 95.7% of patients had an amount of HIV-1 in their system that was lower than 50 copies per milliliter, while 95.3% of patients who stayed on their baseline regimen saw these levels.
"Conducting this women-only study on an international scale helps to further demonstrate that Biktarvy may be appropriate for a wide range of people living with HIV," said Cissy Kityo, the lead investigator on the study.
The most commonly reported side effects in both groups included nasopharyngitis, upper respiratory tract infection, headache, vulvovaginal candidiasis and urinary tract infection. No patient in either group discontinued the study due to a side effect.
The drug was approved by the U.S. Food and Drug Administration on Feb. 7. A marketing authorization application for Biktarvy is under review in the European Union.
