The FDA has approved ViiV Healthcare’s Tivicay PD tablets for oral suspension, or dolutegravir, to treat HIV infection in newborns from birth through four weeks of age who weigh at least 2 kilograms.
Tivicay PD must be used with other antiretroviral agents. The medicine was previously approved for adults and children older than four weeks. The new decision broadens treatment availability to younger infants, including those at risk of acquiring HIV through mother-to-child transmission.
HIV attacks the immune system and can increase the risk of serious infections and cancer. Without treatment, the virus can lead to acquired immunodeficiency syndrome, or AIDS. There is no cure for HIV, but prevention and treatment options are available.
The approval was supported by data from the IMPAACT 2023 study and pharmacokinetic modeling. In the study, 48 newborns exposed to HIV-1 and weighing at least 2 kilograms received Tivicay PD from birth for up to six weeks alongside standard-of-care antiretroviral medicines intended to prevent mother-to-child transmission.
Participants were followed for 16 weeks. Drug levels in newborns were similar to levels associated with efficacy in adults, according to the FDA. The safety profile in newborns was also consistent with that previously observed in older pediatric and adult patients.
The FDA granted Tivicay PD Priority Review for the newborn population. Priority Review is intended to speed review of applications for therapies that may provide significant advances in treatment or meet an unmet medical need.
Tivicay and Tivicay PD should not be used by patients with a prior allergic reaction to the medicine or by those receiving dofetilide. Serious allergic reactions have been reported with the treatment.
Patients receiving Tivicay or Tivicay PD should also be monitored for liver damage. Immune reconstitution syndrome has been reported in people treated with combination antiretroviral therapy.
The FDA cautioned that taking Tivicay or Tivicay PD with certain other medicines could reduce the treatment’s effectiveness against HIV or cause serious side effects. Patients and caregivers should tell healthcare providers about all medicines being taken before treatment begins.
Tivicay tablets and Tivicay PD tablets for oral suspension are not interchangeable on a milligram-for-milligram basis.
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