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Gilead's Biktarvy works as well as current HIV regimen in phase 3 study

Gilead Sciences Inc. said Biktarvy, its single-tablet regimen for treating HIV-1, worked as well as a regimen of abacavir, dolutegravir and lamivudine in a phase 3 study.

The study was conducted in 563 adults with HIV infection who had an undetectable level of the virus in the blood and were taking a regimen of abacavir, dolutegravir and lamivudine, or ABC/DTG/3TC.

"The interest of the study was to provide more data with a new, single-tablet regimen," Jean-Michel Molina, lead researcher and the head of Infectious Diseases Department at the Hospital Saint Louis in Paris, said at a press conference during the 2018 Conference on Retroviruses and Opportunistic Infections held in Boston.

Molina added that the study aimed to highlight the importance of checking if switching from older treatments to the single pill was well-tolerated.

After 48 weeks of treatment, Biktarvy showed high levels of virologic suppression, with a high barrier to resistance. Virologic 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.

Patients treated with Biktarvy also experienced lower instance of drug-related side effects compared to those who received the ABC/DTG/3TC regimen.

"Renal safety in particular is important," Molina said as he noted that neither Biktarvy nor ABC/DTG/3TC patient groups showed treatment resistance, as well as renal side effects causing discontinuation and proximal renal tubulopathy cases, during the 48 weeks. Proximal renal tubulopathy is a disease characterized by too much acid in the blood due to the kidney's failure to properly remove acids from the blood into the urine.

Biktarvy is under additional clinical trials, including a study for women and another in adolescents and children infected with HIV. The drug recently won the U.S. Food and Drug Administration's approval, with a European marketing authorization application in review.