FDA Approves Dolutegravir/Lamivudine for Treatment of Adolescents With HIV-1 Infection


The treatment is indicated for adolescents at least 12 years of age who weigh at least 25 kg without a previous treatment history of antiretroviral therapies.

The FDA has approved dolutegravir/lamivudine (Dovato; ViiV Healthcare) for the treatment of HIV-1 infection in adolescents. The indication is for adolescents who are 12 years of age or older that weigh at least 25 kg who have no previous treatment history of antiretroviral (ARV), or for patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) with no history of treatment failure and who are on a stable ARV regimen looking to replace the current regimen.

FDA approval seal -- Image credit: Aquir | stock.adobe.com

Image credit: Aquir | stock.adobe.com

Dolutegravir/lamivudine is a 2-drug, single tablet regimen that combines 50 mg of dolutegravir, an integrase strand transfer inhibitor (INSTI), with 300 mg of lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI). The treatment is an oral tablet that is taken once per day. The 2 medicines inhibit the viral life cycle at 2 different sites: INSTIs like dolutegravir inhibit HIV integrase by binding to the integrase active site, which prevents the essential step of HIV replication by blocking the strand transfer step of retroviral DNA integration. NRTIs such as lamivudine inhibit the reverse transcriptase through the termination of DNA chains.

The FDA approval comes after data from the ongoing single-arm, multicenter, open-label phase 3b trial, DANCE (NCT03682848), which is evaluating the once-daily, fixed-dose of dolutegravir/lamivudine as an initial ARV therapy in 32 adolescents between the ages of 12 and 18 years who weigh at least 25 kg. Each patient was treated with 50 mg of dolutegravir and 300 mg of lamivudine. In addition, each patient had HIV-1 RNA of 1000 to 500,000 c/mL or less and all were treatment-naïve. The study’s primary endpoint was proportion achieving HIV-1 RNA of 50 c/mL or less at week 48.

About the Trial

Trial Name: Safety and Efficacy of Dolutegravir/​Lamivudine (DTG/​3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents

ClinicalTrials.gov ID: NCT03682848

Sponsor: ViiV Healthcare

Completion Date (Estimated): February 23, 2024

According to the findings, 26 of the 30 participants who completed the study achieved and maintained viral suppression at week 48. Further, the safety and efficacy data in the enrolled adolescents were comparable to that of adults, who were studied in the GEMINI-1 and GEMINI-2 trials (adult patients who received no prior treatment) as well as the TANGO trial (adult patients who received prior treatment). Although exposures for components of dolutegravir/lamivudine were higher, they were not considered statistically significant.

“This expanded indication for [dolutegravir/lamivudine] brings an oral, 2-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,” said Lynn Baxter, Head of North America at ViiV Healthcare, in a press release.

The most common adverse effects (AEs) for those who received treatment with dolutegravir/lamivudine (all grades, incidence ≥2%) were headache (3%), nausea, diarrhea, fatigue, insomnia, and anxiety, all of which had an incidence of 2%. Other potential AEs include hypersensitivity reactions (eg, rash, liver injury, or organ dysfunction), hepatotoxicity (eg, elevated serum liver biochemistries, hepatitis, and acute liver failure), embryo fetal toxicity, lactic acidosis, and severe hepatomegaly with steatosis.

“As a leader in HIV, [we are] 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,” said Baxter in the press release.

BioSpace. ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV. News release. April 8, 2024. Accessed April 8, 2024. https://www.biospace.com/article/releases/viiv-healthcare-announces-u-s-fda-approval-of-dovato-dolutegravir-lamivudine-for-adolescents-living-with-hiv/
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