New Dosage Form and Expanded Indications for Harvoni, Sovaldi
September 5, 2019 – The U.S. FDA has approved oral pellet dosage forms for Sovaldi® (sofosbuvir) and Harvoni® (ledipasvir/sofosbuvir), manufactured by Gilead. The FDA has also granted an extended pediatric indication to each product.
Previously indicated to treat hepatitis C virus (HCV) infection in certain patients as young as 12 years of age, Sovaldi and Harvoni are now approved to treat children as young as three years old who meet the necessary criteria. Children receiving Sovaldi must have genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis, and receive concurrent treatment with ribavirin. Harvoni patients must meet one of the following criteria:
- Have genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis;
- Have genotype 1 infection with decompensated cirrhosis and receive concurrent treatment with ribavirin; or
- Have genotype 1 or 4 infection and be liver transplant recipients without cirrhosis or with compensated cirrhosis and receive concurrent treatment with ribavirin.
Recommended dosing for each medication is based on individual patient factors. A standard course of treatment with Sovaldi is either 12 or 24 weeks, depending on the HCV genotype being treated, while Harvoni has a 12-week standard course of treatment regardless of genotype. Both products carry a black box warning for hepatitis B virus (HBV) worsening or reactivation in patients who are coinfected.
The new oral pellet versions of Sovaldi and Harvoni can be sprinkled on non-acidic food, such as pudding, that is and served at or below room temperature. They come in 200mg and 150mg dosage strengths for Sovaldi, and 45mg ledipasvir/200mg sofosbuvir and 33.75mg ledipasvir/150mg sofosbuvir dosage strengths for Harvoni. Launch and pricing information are not yet available.