Expanded Indication and New Dosage Form for Tivicay

June 12, 2020 – The U.S. FDA has approved Tivicay® PD (dolutegravir) tablets for oral suspension, manufactured by ViiV Healthcare, for use in combination with other antiretroviral therapies to treat human immunodeficiency virus 1 (HIV-1) infection in pediatric patients who are at least four weeks old and weigh at least 3kg (6.61 pounds). The agency also extended the indication of Tivicay® (dolutegravir) film-coated tablets to include the same patient population. Previously, Tivicay film-coated tablets were only approved for use in pediatric patients who weighed at least 20kg (44 pounds).

Most young children infected with HIV-1 receive the virus from their mother during pregnancy, birth, or breastfeeding. Early intervention helps slow progression of the infection, which can be more aggressive in children than in adults. HIV attacks the body’s immune system and can cause severe damage if left untreated. This can lead to potentially fatal acquired immunodeficiency syndrome (AIDS).

In clinical trials, Tivicay and Tivicay PD demonstrated safety and efficacy in pediatric patients comparable to that seen in adults taking dolutegravir. At 48 weeks, 69% of pediatric patients had an undetectable HIV viral load, meaning the virus could not be found in their blood samples. Patients also had, on average, higher levels of CD4 cells. These cells help the body fight infection but are often destroyed by HIV. They are used as an indicator of the severity of HIV infection, with lower levels of CD4 cells indicating a more serious infection.

Pediatric patients who receive either Tivicay or Tivicay PD should not have been previously treated with an integrase strand transfer inhibitor (INSTI) drug therapy. Recommended dosing is based on weight and whether the patient is taking Tivicay or Tivicay PD. The two drugs are not interchangeable on a milligram-per-milligram basis and require different dosing.

Originally FDA approved in 2013, Tivicay film-coated tablets are also approved for use in combination with rilpivirine as a complete treatment regimen for HIV-1 infection in certain adults.