FDA approves dolutegravir/lamivudine to treat HIV infection in adolescents
The treatment is approved for adolescents aged 12 years and older.
Image Credit: © Calin - © Calin - stock.adobe.com.
Dolutegravir/lamivudine (Dovato; ViiV Healthcare [majority owned by GSK]) has been approved by the FDA for the treatment of HIV-1 infection in adolescents aged 12 years and older who weigh at least 55.11 lbs (25 kg), ViiV announced in a press release.
The indication is approved for those with no antiretroviral (ARV) treatment history or to replace current ARV regimen in those, "are virologically suppressed (HIV-1 RNA less than 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 [dolutegravir/lamivudine]," ViiV stated.
The decision by the federal agency was supported by the ongoing phase 3b DANCE study (NCT03682848), a single-arm, multicenter, open-label study evaluating the once-daily, fixed-dose combination of dolutegravir/lamivudine (50 mg / 300 mg] as initial ARV therapy for the approved population. The trial enrolled 32 participants across 9 centers in Thailand, Kenya, and South Africa.
The primary outcome assessed proportions achieving HIV-1 RNA <50 c/mL at week 48. According to ViiV, 26 of 30 participants achieved and maintained viral suppression at week 48, and that safety and efficacy data observed in the trial were "comparable" to data demonstrated in adult trials.
The once-daily, oral, 2-drug, single-tablet regiment "combines the integrase strand transfer inhibitor (INSTI) dolutegravir (50 mg) with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (300 mg)."
The 2 medicines inhibit the viral life cycle at 2 different sites. INSTIs inhibit 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 replication cycle," stated ViiV. The company added the principal mode of action of lamivudine is inhibition of reverse transcriptase via DNA chain termination.
A boxed warning states "PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV," according to the release.
ViiV also noted that all patients with HIV-1 should be tested for the presence of HBV prior to or when initiating dolutegravir/lamivudine.
Click here for full safety information.
Reference:
ViiV Healthcare announces US FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV. ViiV Healthcare. 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
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