EPCLUSA(sofosbuvir 400mg/velpatasvir 100mg)
sofosbuvir/velpatasvir - Drug Summary
CLASSES
Other Anti-Hepatitis Drugs
BOXED WARNING
Hepatitis B exacerbation
Use of direct-acting antivirals (DAA), such as sofosbuvir and velpatasvir, to treat hepatitis C virus (HCV) infections in patients currently or previously infected with hepatitis B virus (HBV) has been associated with reactivation and exacerbation of the HBV infection. To decrease the risk of reactivating a HBV infection, screen all potential drug recipients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc concentrations. For those patients whose screening reveals serologic evidence of HBV infection, a baseline HBV DNA concentration should be obtained prior to starting sofosbuvir; velpatasvir. Continue to monitor coinfected patients during and after treatment for clinical and laboratory signs of hepatitis B exacerbation (i.e., HBsAg, HBV DNA, hepatic enzymes, bilirubin). In addition, instruct patients to immediately report any signs of liver toxicity (e.g., yellow eyes or skin, fatigue, weakness, loss of appetite, nausea, vomiting, or light-colored stools) to their health care provider. If a sofosbuvir; velpatasvir recipient develops signs of HBV reactivation, consult a physician with expertise in the management of hepatitis infections. The FDA has identified and confirmed 24 cases of hepatitis B exacerbation (including fulminant hepatitis, hepatic failure requiring liver transplant n = 1, and death n = 2) in coinfected patients treated with a DAA-based HCV regimen between November 2013 and July 2016. The exact mechanism is unknown; however, a commonly reported sequence of events included initiation of a DAA-based HCV regimen, rapid drop in HCV RNA to undetectable levels within 1 to 2 weeks of liver enzyme normalization, followed by a rise in HBV DNA (with or without increased transaminases) between treatment weeks 4 and 8. Of the 24 reported cases: 8 discontinued the DAA when transaminases began to rise; 12 received HBV treatment with tenofovir or entecavir; 6 did not receive HBV treatment; and 6 did not report whether HBV treatment was used.
DEA CLASS
Rx
DESCRIPTION
Combination oral product
Used to treat adults infected with chronic hepatitis C virus (HCV) with and without cirrhosis
First regimen approved for all HCV genotypes
COMMON BRAND NAMES
Epclusa
HOW SUPPLIED
Sofosbuvir, Velpatasvir Oral Tab: 400-100mg
DOSAGE & INDICATIONS
For the treatment of chronic hepatitis C infection, including genotype 1, 2, 3, 4, 5, and 6.
For the treatment of chronic hepatitis C infection in patients without cirrhosis and in patients with compensated cirrhosis (Child-Pugh A).
Oral dosage
Adults
One tablet (400 mg sofosbuvir; 100 mg velpatasvir) PO once daily for 12 weeks.
For the treatment of chronic hepatitis C infection in patients with decompensated cirrhosis (Child-Pugh B or C).
Oral dosage
Adults
One tablet (400 mg sofosbuvir; 100 mg velpatasvir) PO once daily plus ribavirin for 12 weeks. The dose of ribavirin is based on weight as follows: less than 75 kg give 500 mg PO twice daily; 75 kg or more give 600 mg PO twice daily.
MAXIMUM DOSAGE
Adults
400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.
Geriatric
400 mg/day PO for sofosbuvir; 100 mg/day PO for velpatasvir.
Adolescents
Safety and efficacy not established.
Children
Safety and efficacy not established.
Infants
Safety and efficacy not estab |
