Originally published by our sister publication Infectious Disease Special Edition

The FDA granted a new indication for dolutegravir-lamivudine (DTG-3TC; Dovato, ViiV Healthcare) to treat HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg.

DTG-3TC can be given to adolescents with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DTG-3TC.

In the United States, 20% of new HIV diagnoses in 2020 were among young people aged 13 to 24 years. This expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12 and 18 years of age living with HIV.

“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,” said Lynn Baxter, the head of North America at ViiV Healthcare.

The approval is supported by data from the DANCE study, which evaluated DTG-3TC in treatment-naive adolescents as well as evidence from well-controlled trials in adults living with HIV: GEMINI-1 and GEMINI-2 (treatment-naive adults) and TANGO (treatment-experienced adults). 

DANCE (ClinicalTrials.gov Identifier: NCT03682848) is an ongoing phase 3b, single-arm, multicenter, open-label study evaluating the once-daily, fixed-dose combination of DTG-3TC  (50 mg/300 mg) as initial ARV therapy for adolescents 12 to 17 years and weighing at least 25 kg, with HIV-1 RNA of 1,000 to no more than 500,000 copies/mL. The primary end point assessed proportions achieving HIV-1 RNA less than 50 cop-ies/mL at week 48. A total of 32 participants were enrolled across nine centers from Thailand, Kenya and South Africa.

Results from the DANCE study showed that 26 of 30 participants achieved and maintained viral suppres-sion at week 48. 

The safety and efficacy data in adolescents from the DANCE study were comparable with those observed in adults. Exposures for components of DTG-3TC were higher but not clinically significant.

DTG-3TC is a once-daily, oral, two-drug, single-tablet regimen that combines the integrase strand transfer inhibitor dolutegravir (50 mg) with the nucleoside reverse transcriptase inhibitor lamivudine (300 mg), which 
inhibit the viral life cycle at two different sites: DTG inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration, which is essential for the HIV replica-tion cycle, and 3TC inhibits reverse transcriptase via DNA chain termination.

DTG-3TC  carries a boxed warning about using the medication in people with hepatitis B virus (HBV) coin-fection. All patients with HIV-1 should be tested for the presence of HBV before or when initiating DTG-3TC.

Emergence of 3TC-resistant HBV variants associated with lamivudine-containing ARV regimens has been re-ported. If DTG-3TC  is used in patients who are coinfected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. For more see the complete package information.