The U.S. Food and Drug Administration (FDA) has approved the use of Dovato for treating HIV-1 infection in adolescents aged 12 and above weighing at least 25 kg. This approval marks a significant milestone, as it is the first time an oral, two-drug, single-tablet regimen has been made available for adolescents living with HIV.
Dovato is a combination of dolutegravir and lamivudine, which work together to inhibit the virus at two different stages of its replication cycle. The approval was based on data from the DANCE study, which showed that the majority of adolescents who took Dovato achieved and maintained viral suppression for 48 weeks.
The safety and efficacy of Dovato in adolescents were comparable to those observed in adults. However, higher exposures to the components of Dovato were noted, but these were not clinically significant.
This expanded indication for Dovato provides adolescents with a more convenient and effective treatment option that requires fewer medications. It underscores ViiV Healthcare’s commitment to developing and delivering innovative therapies for people living with HIV, including young people.
According to Lynn Baxter, Head of North America at ViiV Healthcare, this approval is an important step in addressing the treatment needs of young people with HIV. As a leader in HIV care, ViiV Healthcare remains dedicated to improving and expanding treatment options for children and adolescents, particularly in communities where access to care may be limited.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
