ViiV wins US approval for HIV treatment in newborn babies

The US FDA has green lit ViiV Healthcare’s Tivicay PD (dolutegravir) for the treatment of HIV-1 in children weighing at least 2 kg, including eligible newborns from birth.

The approval allows dolutegravir, the active ingredient in Tivicay PD, to be used in combination with other HIV medications in some of the youngest patients living with HIV in the US who have not previously received integrase strand transfer inhibitors.

It is the first second-generation integrase strand transfer inhibitor, or INSTI, approved for newborns in this weight range, according to ViiV.

The FDA based its decision on results from the NIH-funded International Maternal Paediatric Adolescent AIDS Clinical Trials (IMPAACT) 2023 study, as well as pharmacokinetic modelling using paediatric data.

Results of the study showed that that dolutegravir reached therapeutic drug levels in term neonates with a safety profile consistent with that established in older paediatric and adult populations.

“Today’s approval of Tivicay PD expands the options available for paediatric HIV care, giving families and clinicians in the US greater choice from the very beginning of life,” said Jean van Wyk, MBChB, MFPM, chief medical officer at ViiV Healthcare, in a statement. “For ViiV Healthcare, it reflects our commitment to bringing INSTI-based innovation to children and addressing persistent gaps in HIV care. This progress has been made possible through vital collaboration with the HIV community, united by a shared focus on ensuring children living with HIV are not left behind.”

The move addresses a longstanding gap in paediatric HIV treatment. Infants can progress rapidly without effective treatment, with around half of untreated children living with HIV dying by the age of two, according to ViiV.

“For too long, newborns living with HIV have had too few treatment options designed and studied to meet their unique needs, despite the importance of starting treatment as early as possible,” said Diana F Clarke, PharmD, Assistant Professor of Paediatrics, Boston University School of Medicine, and lead investigator of the IMPAACT 2023 study. “With the approval of a Tivicay PD dosing regimen, babies born at term and weighing at least 2 kg will now have access to dolutegravir-based therapy starting at birth. This represents an important advance for the care of newborns, as early treatment with the most effective therapies results in the best possible outcomes.”

Both Tivicay and Tivicay PD contain dolutegravir, which, according to ViiV, works by blocking HIV integrase, an enzyme the virus needs to insert its genetic material into human cells. Moreover, as a second-generation INSTI, the company also notes that has a higher barrier to resistance than earlier drugs in the class.