The US Food and Drug Administration (FDA) has approved a paediatric formulation of the HIV medicine dolutegravir for use in newborns from birth, expanding treatment options for babies with HIV.

The approval applies to Tivicay PD tablets for oral suspension in babies from birth to four weeks of age who weigh at least 2 kg. The medicine is used in combination with other antiretroviral drugs to treat HIV infection. Tivicay and Tivicay PD had previously been approved for adults and children older than four weeks.

The decision is significant because HIV treatment needs to begin as early as possible in babies who have acquired the virus. Without treatment, HIV attacks the immune system and can increase the risk of serious infections and some cancers. Untreated HIV can eventually progress to AIDS.

There is currently no cure, but antiretroviral treatment can suppress the virus and help people with HIV live longer, healthier lives.

What Is the New Treatment?

Tivicay PD contains dolutegravir, an integrase strand transfer inhibitor. It works by interfering with HIV's ability to integrate its genetic material into human cells, an essential step in the virus's replication process.

Tivicay PD is designed to be given as an oral suspension, making it suitable for very young babies who cannot swallow conventional tablets.

The FDA approval covers newborns weighing at least 2 kg and up to four weeks old. It is intended to be given alongside other antiretroviral medicines rather than as a standalone treatment.

What Evidence Supported the Approval?

The FDA based its decision partly on data from the IMPAACT 2023 study, alongside pharmacokinetic modelling.

The study included 48 newborns exposed to HIV-1, all weighing at least 2 kg. They received Tivicay PD from birth for up to six weeks alongside standard antiretroviral medicines intended to prevent mother-to-child transmission. The babies were then followed for 16 weeks.

Researchers found that drug levels in the newborns were similar to levels associated with effectiveness in adults. The safety profile was also similar to what has been observed in older children and adults receiving the medicine. The FDA gave Tivicay PD priority review for this newborn population.

Can HIV Be Prevented From Passing From Mother to Baby?

Yes. Antiretroviral medicines given during pregnancy and around the time of birth can dramatically reduce the risk of mother-to-child HIV transmission when appropriate treatment and medical care are provided.

However, babies can still be exposed to HIV during pregnancy, delivery, or breastfeeding. This is why newborns considered at risk require careful medical assessment and, in some circumstances, antiretroviral medicines soon after birth.

The new approval therefore provides another treatment option for clinicians caring for newborns who have HIV or require antiretroviral therapy based on their individual circumstances.

Is Tivicay PD Safe for Newborns?

The FDA said the safety profile observed in the newborn study was similar to that seen in older paediatric and adult patients. However, like other medicines, dolutegravir can cause side effects and requires medical supervision.

Serious allergic reactions have been reported, and patients should be monitored for possible liver damage. Immune reconstitution syndrome has also been reported in people receiving combination antiretroviral therapy.

Tivicay PD should not be given to patients who have previously experienced an allergic reaction to dolutegravir or who are taking the medicine dofetilide, because of the risk of serious interactions. Parents and caregivers should tell healthcare professionals about every medicine their baby is receiving.

Importantly, Tivicay tablets and Tivicay PD are not interchangeable on a milligram-for-milligram basis, meaning parents should not change formulations or doses without medical advice.

Read more