FDA Approves HIV Therapy for Adolescents

News
Article

The federal agency has given the nod for dolutegravir/lamivudine (Dovato) for teens living with the virus and offers a novel option for patients.

The FDA has approved dolutegravir/lamivudine (Dovato, ViiV Healthcare) for adolescents living with HIV. This therapy becomes the first and only oral, 2-drug, single-tablet regimen available for people aged 12 and older living with HIV.1

"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,”Lynn Baxter, Head of North America at ViiV Healthcare, said in a statement.1

Dovato combines the integrase strand transfer inhibitor (INSTI) dolutegravir (50 mg) with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine (300 mg). 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.1

What You Need to Know

This approval offers a novel treatment option that combines dolutegravir, an integrase strand transfer inhibitor, with lamivudine, a nucleoside reverse transcriptase inhibitor, potentially simplifying treatment regimens for adolescents.

Results from the DANCE study showed that a significant proportion of adolescents achieved and maintained viral suppression at Week 48.

The FDA approval coincides with National Youth HIV and AIDS Awareness Day, highlighting the importance of addressing HIV awareness and treatment among young people.

What the Data Showed
The FDA approval is based around 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. The safety and efficacy data in adolescents from the DANCE study were comparable to those observed in adults.Exposures for components of Dovato were higher but were not clinically significant.1

National Youth HIV and AIDS Awareness Day
This FDA approval news comes ahead of National Youth HIV and AIDS Awareness Day on Wednesday. This annual day is an opportunity to recognize this population across the country in high schools, colleges, places of worship, and more.2

According to the Centers for Disease Control and Prevention (CDC), approximately 50,000 people are infected with HIV each year, and that 1 in 4 people are between the ages of 13 to 24 years. Young people make up 7% of the more than 1 million people in the US living with HIV.2

And approximately 60% of young people with HIV do not know they have it, so they do not seek treatment—which can not only put them at risk for severe illness and death—but they can unknowingly transmit HIV to others.2

Watch a past Contagion interview with a clinician who speaks of the challenges these younger patients face.


References

1.ViiV Healthcare announces U.S. FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV. ViiV 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

2.Parkinson J. National Youth HIV and AIDS Awareness Day is an Opportunity to Celebrate Strides, Educate These Populations. Contagion. April 10,2022. Accessed April 8, 2024.
https://www.contagionlive.com/view/national-youth-hiv-and-aids-awareness-day-is-opportunity-to-celebrate-strides-educate-these-populations

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