FDA Approves DOVATO (DOLUTEGRAVIR/LAMIVUDINE) for Adolescents living with HIV
Published on MedED: 14 April 2024
Originally published: 08 April 2024
Source: ViiV Healthcare Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN007
Category: Paediatrics & Neonatology
Crossreference: HIV, Infectious Diseases
Category tags: HIV, Virology
Originally published: 08 April 2024
Source: ViiV Healthcare Press Release
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN007
Category: Paediatrics & Neonatology
Crossreference: HIV, Infectious Diseases
Category tags: HIV, Virology
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Phase 3b Trial |
April 08,, 2024/ViiV Press Release
Dolutegravir/lamivudine (Dovato) has received FDA approval for treating HIV-1 infection in adolescents aged 12 years and older.
This approval applies to treatment-naive adolescents or those already virologically suppressed on a stable antiretroviral regimen with no history of treatment failure or resistance to the individual components of dolutegravir/lamivudine.
The decision was based on findings from the phase 3b DANCE study, which demonstrated comparable safety and efficacy to adult trials, with 26 out of 30 participants maintaining viral suppression at week 48.
Dolutegravir/lamivudine is an oral, once-daily, 2-drug, single-tablet regimen combining the integrase strand transfer inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitor lamivudine, targeting different stages of the viral life cycle.
Clinical Trials & Supporting Information
| Clinical Study | ClinicalTrial.gov Registration | ClinicalTrial.gov Registration |
|---|---|---|
Access Original Press Release
ViiV HEALTHCARE ANNOUNCES U.S. FDA APPROVAL OF DOVATO (DOLUTEGRAVIR/LAMIVUDINE) FOR ADOLESCENTS LIVING WITH HIV
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This article is compiled from a variety of resources. Every effort has been made to correctly attribute quotes and content. Where possible all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us
Fact-checking Policy
The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please make use of the contact us form to notify us.
