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ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV
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Published: Apr 08, 2024
• Dovato is now the first and only oral, two-drug, single-tablet regimen available for people aged 12 and older living with HIV, a population in need of additional treatment options
DURHAM, N.C.--(BUSINESS WIRE)-- ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who 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 Dovato.1
In the U.S., 20 percent of new HIV diagnoses in 2020 were among young people aged 13-24.2 This expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12- and 18-years old living with HIV and underscores ViiV Healthcare’s ongoing commitment to bringing more therapeutic options to young people.
Lynn Baxter, Head of North America at ViiV Healthcare, said: "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. 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.”
The approval is supported by data from the DANCE study which evaluated Dovato in treatment-naïve adolescents as well as evidence from well-controlled trials in adults living with HIV, GEMINI-1 and GEMINI-2 (treatment-naïve adults) and TANGO (treatment-experienced adults).1 Results from the DANCE study, which included adolescents between 12- and 18-years old weighing at least 25 kg with HIV-1 RNA 1000 to ≤500,000 c/mL, showed that 26/30 participants achieved and maintained viral suppression at Week 48.1 The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults.1 Exposures for components of Dovato were higher but were not clinically significant.1
About Dovato (dolutegravir/lamivudine)1,3
Dovato is a once-daily, oral, two-drug, single-tablet regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir (50 mg) with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (300 mg).
Dovato contains two medicines to inhibit the viral life cycle at two different sites. INSTIs, like dolutegravir 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. The principal mode of action of lamivudine, an NRTIs, is inhibition of reverse transcriptase via DNA chain termination.
Dovato is approved in the U.S., Europe, Japan, Australia and other countries worldwide.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
About the DANCE Study
DANCE (NCT03682848) is an ongoing phase 3b, single-arm, multicenter, open-label study evaluating once-daily, fixed-dose combination of Dovato (50 mg/300 mg) as initial ARV therapy for adolescents aged ≥12 to <18 years and weighing ≥25 kg, with HIV-1 RNA 1000 to ≤500,000 c/mL. The primary endpoint assessed proportions achieving HIV-1 RNA <50 c/mL at Week 48. A total of 32 participants were enrolled across nine centers from Thailand, Kenya, and South Africa.1
DOVATO (dolutegravir and lamivudine) tablets
INDICATION
DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.
Link to Full press release
https://us.gsk.com/en-us/media/press-releases/viiv-healthcare-announces-us-fda-approval-of-dovato-for-adolescents-living-with-hiv/
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