ViiV Healthcare Submits FDA Application for HIV Regimen

ViiV Healthcare recently announced it made a regulatory submission to FDA for approval of a new dispersible tablet regimen for children living with HIV.

The tablet formulation, Triumeq, includes abacavir, dolutegravir, and lamivudine. ViiV Healthcare also requested approval to extend its current approval for Triumeq to lower the minimum weight at which a caregiver can prescribe a child this medicine from 88 to 30 pounds.

About 74 percent of adults living with HIV have access to treatment, compared to only 54 percent of children, according to a 2020 study from UNAIDS.

For example, in January 2021, FDA approved ViiV Healthcare’s Cabenuva. This treatment is the first and only complete long-acting injectable HIV treatment for positive adults.

If FDA approves Triumeq, younger children living with HIV will have a broader range of treatment options.

“This is a stark reminder of the gap between treatment options for adults and children and this submission represents another important step in ensuring that we address this disparity. By broadening the treatment options available to children living with HIV, we are one step closer to ending pediatric HIV and AIDS,” Deborah Waterhouse, CEO of ViiV Healthcare, said in the announcement.

HIV is a global issue that disproportionately affects children. Currently, about 1.7 million children are living with HIV globally. Most AIDS-related deaths in this age group occur during the first five years of life.

Antiretroviral therapy (ART) for HIV is a treatment regimen used to reduce the virus in the body. Although there is no cure for HIV, ART can slow the progress of the infection and reduce the chances of transmission to others.

But significant obstacles persist for children, such as the availability of HIV testing, continued vertical transmission, slow initiation of treatment, and little to no access to ART.

According to STAT, only 54 percent of children received access to antiretroviral therapy (ART) globally in 2020, compared with 62 percent of adults.

Of these individuals, over a third were taking sub-optimal or age-inappropriate treatments. Without correct diagnosis and optimal treatment options, half of HIV-positive infants will die before the age of two and only one in five will survive to the age of five.