ViiV Healthcare Updates Warning Label for Triumeq

ViiV Healthcare has updated the boxed warning label for Triumeq and Triumeq PD to include additional information about the possibility of flare ups of hepatitis b infection in patients who have both HIV and hepatitis B. Triumeq is a one-daily combination of three medications (dolutegravir, abacavir, lamivudine) used to treat patients with treat HIV infections.

The language in the new Triumeq PD label regarding HBV coinfection is not based on new data, according to a company spokesperson. “Rather, it came through an FDA label review and the agency’s desire to align the language in the Triumeq and Dovato labels. Both labels now highlight to prescribers the need for awareness of HBV coinfection as a possibility, and the need for specific treatment to be considered in this scenario,” the spokesperson said.

Dovato, also developed by ViiV Healthcare, is a combination of dolutegravir and lamivudine used to treat people with HIV infection. Dovato in a once-daily therapy was approved by the FDA in April 2019. Dovato’s labeling at the time of approval contained a warning about use in patients who have both HIV and hepatitis B. The FDA noted that patients with both infections who take products containing lamivudine, have developed hepatitis B variants associated with resistance to lamivudine and may have severe liver problems, including liver failure.

In March 2022, the FDA approved Triumeq PD (a dispersible tablet formulation that disintegrates quickly in water) for children with HIV and lowered the minimum weight that children could be prescribed Triumeq tablets. Triumeq was first approved in August 2014.

The boxed warning section of the Triumreq labels now read (the addition is underlined):

“Exacerbations of Hepatitis B

“All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating Triumeq or Triumeq PD. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If Triumeq or Triumeq PD is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

“Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued lamivudine, a component of TRIUMEQ and TRIUMEQ PD. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.”