FDA approves first two-drug pill for HIV in adolescents
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Key takeaways:
- For the first time, adolescents with HIV have the option of a two-drug, single-tablet oral treatment regimen.
- Trials showed that 26 of 30 participants achieved and maintained viral suppression through 48 weeks with the drug.
Teens in the United States have another treatment option for HIV.
The FDA on Monday approved an expanded indication for Dovato as the first oral, two-drug, single tablet regimen for HIV in adolescents aged 12 years or older, ViiV Healthcare announced.
Dovato, which contains the drugs dolutegravir and lamivudine, was already approved for ART-naive and virologically suppressed adults with HIV.
It is now also approved for adolescents weighing at least 25 kg with either no ART history or who are virally suppressed on another regimen with no history of treatment failure.
“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 press release.
According to the company, the approval was supported by data from the DANCE study, which evaluated the combination among treatment-naive adolescents, and evidence from three trials conducted among adults.
In the DANCE study, which included adolescents aged between 12 and 18 years weighing at least 25 kg with HIV RNA between 1,000 and 500,000 c/mL, 26 of 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, the company said.
ART is recommended for all children with HIV, and multiple options are available for adolescents.
Perspective
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The FDA approval of Dovato (dolutegravir/lamivudine) for adolescents living with HIV provides another tool in the toolbox to effectively treat HIV in adolescents aged 12 years and up. Currently, there are only a few one-pill, once-a-day HIV treatment options for this age group, and this approval expands those options because Dovato is an effective two-drug, single-tablet, once-a-day, complete HIV treatment.
Many studies have shown that taking daily medication is challenging for anyone, and even harder for adolescents. Thus, regimens that simplify administration and provide effective treatment are critical in this age group. Not only that, but when patients living with HIV take their medications properly, they are able to suppress the HIV virus and achieve an undetectable viral load. Once a patient has a sustained undetectable viral load for at least 6 months, the patient cannot transmit HIV to others — an important public health prevention strategy.
We know that approximately one in five new cases of HIV in the United States occur among patients aged 13 to 24 years, so doctors recommend a status-neutral HIV approach, where every person obtains an HIV test as a routine part of health care. If that test is positive, the patient can take a once-a-day HIV regimen, and if that test is negative, then they can pursue an HIV prevention approach with PrEP.
Having new treatment options for adolescents living with HIV improves medication adherence and delivers successful treatment outcomes.
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