FDA Approves Expanded Indication for Dovato to Include Adolescent Patients with HIV

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ViiV Healthcare has announced the FDA approval of the once-daily, oral medication Dovato (dolutegravir/lamivudine; ViiV Healthcare) to treat HIV-1 infection in adolescents aged 12 years and older who weigh at least 25 kg, who have no prior use of antiretroviral (ARV) therapy, or to replace the current ARV regimen in virologically suppressed patients (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions linked to resistance to the individual components of the drug. The regulatory action makes Dovato the first oral, two-drug, single-tablet regimen indicated for patients 12 years of age and older who are living with HIV.¹

"This expanded indication for Dovato brings an oral, two-drug, single-tablet regimen to adolescents living with HIV, providing a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment,” Lynn Baxter, head of North America at ViiV Healthcare, said in a press release. “As a leader in HIV, ViiV Healthcare is proud of our focused efforts to improve and expand care for children and adolescents and we remain committed to addressing the existing treatment gaps in these communities.”

Twenty percent of new HIV diagnoses in 2020 in the United States were reported in individuals between 13 and 24 years of age.¹ The expanded indication for Dovato marks a significant milestone in providing more therapeutic options to younger patients.

Dovato is comprised of 50 mg of the integrase strand transfer inhibitor (INSTI) dolutegravir and 300 mg of the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine. INSTIs inhibit HIV integrase by attaching to the integrase active site, thereby preventing HIV replication by blocking the strand transfer step of retroviral DNA integration. NRTIs halt the reverse transcriptase via the termination of DNA chains.

The FDA based its approval on findings from the ongoing, single-arm, multicenter, open-label Phase IIIb DANCE (NCT03682848) trial. The study analyzed the once-daily, fixed-dose Dovato (50 mg/300 mg) as an initial ARV regimen in 32 participants between 12 and 18 years of age, weighing at least 25 kg, with HIV-1 RNA 1000 to ≤500,000 c/mL.

The trial’s primary endpoint was to evaluate proportions achieving HIV-1 RNA <50 c/mL at week 48. Participants in the trial were enrolled across nine treatment centers from Thailand, Kenya, and South Africa.

Investigators found that 26 of 30 participants who completed the trial achieved and maintained viral suppression at week 48. Safety and efficacy findings for the adolescents in the trial were comparable to findings for adults stemming from the GEMINI-1 and GEMINI-2 trials, which included adult patients with no prior treatment history, and the TANGO trial, which included previously treated adults. Exposures for the components of dolutegravir and lamivudine were higher in adolescent patients, however, it was not deemed statistically significant.

In terms of safety, the most common adverse events (AEs) in the Dovato treatment cohort (all grades, incidence ≥2%) were headache at a rate of 3%, and nausea, diarrhea, fatigue, insomnia, and anxiety, all at a rate of 2%. Other reported AEs include hypersensitivity reactions, such as rash, liver injury, or organ dysfunction; hepatotoxicity, such as increased serum liver biochemistries, hepatitis, and acute liver failure; as well as embryo fetal toxicity, lactic acidosis, and severe hepatomegaly with steatosis.

Reference

ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV. ViiV press release. April 8, 2024. Accessed April 8, 2024.
https://www.businesswire.com/news/home/20240319579558/en/ViiV-Healthcare-announces-U.S.-FDA-approval-of-Dovato-dolutegravirlamivudine-for-adolescents-living-with-HIV