Applies to sofosbuvir / velpatasvir: oral film-coated pellets, oral film-coated tablets.
Warning
-
Risk of HBV Reactivation in Patients Coinfected with HCV and HBV
- HBV reactivation, including cases resulting in fulminant hepatitis, hepatic failure, and death, reported in patients coinfected with HCV and HBV who were receiving or had completed treatment with HCV direct-acting antivirals (DAAs) and were not receiving HBV antiviral therapy.1 25
- Test all patients for evidence of current or prior HBV infection before initiating fixed combination of sofosbuvir and velpatasvir (sofosbuvir / velpatasvir).1 25
- Monitor patients coinfected with HCV and HBV for hepatitis flare or HBV reactivation during and after HCV treatment.1 25 Initiate appropriate management for HBV infection as clinically indicated.1
Side effects include:
Sofosbuvir / velpatasvir in adult and pediatric patients ≥6 years of age or older (≥10%): Headache and fatigue.
Sofosbuvir / velpatasvir in pediatric patients <6 years of age: (≥10%): Vomiting and product use issue (spitting up the drug).
Sofosbuvir / velpatasvir in conjunction with ribavirin in adults with decompensated cirrhosis (≥10%): Fatigue, anemia, nausea, headache, insomnia, and diarrhea.
For Healthcare Professionals
Applies to sofosbuvir / velpatasvir: oral pellet, oral tablet.
General
The most common side effects reported with this drug were fatigue, headache, nausea, and nasopharyngitis. When this drug was studied with ribavirin, the most common side effects were fatigue, anemia, nausea, headache, insomnia, and diarrhea.
The most common side effects in liver transplant recipients (without cirrhosis or with compensated cirrhosis) were headache, fatigue, nausea, diarrhea, and asthenia.
The most common side effect in patients with hepatitis C virus (HCV) with compensated liver disease (with or without cirrhosis) and end-stage renal disease requiring dialysis was nausea.
If this drug is used with ribavirin, the manufacturer product information for ribavirin should be consulted for associated side effects.[Ref]
Other
Very common (10% or more): Fatigue (up to 32%)
Common (1% to 10%): Asthenia, irritability[Ref]
Nervous system
Very common (10% or more): Headache (up to 29%)[Ref]
Hematologic
Very common (10% or more): Anemia (26%), decreased hemoglobin (up to 23%)[Ref]
Decreases in hemoglobin to less than 10 g/dL and 8.5 g/dL during combination therapy were reported in 23% and 7% of subjects, respectively.[Ref]
Gastrointestinal
Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in up to 6% of subjects.
Vomiting and spitting up the drug was reported in 15% and 10% of pediatric patients younger than 6 years (n=41), respectively.[Ref]
Very common (10% or more): Nausea (up to 15%)
Common (1% to 10%): Diarrhea, increased lipase
Frequency not reported: Vomiting, spitting up the drug[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (up to 12%)
Common (1% to 10%): Cough
Psychiatric
Very common (10% or more): Insomnia (up to 11%)
Uncommon (0.1% to 1%): Depressed mood[Ref]
Cardiovascular
Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used in combination with amiodarone and/or other agents that lower heart rate.
Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a regimen containing sofosbuvir.[Ref]
Frequency not reported: Severe bradycardia, heart block
Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)[Ref]
Dermatologic
Common (1% to 10%): Rash
Frequency not reported: Stevens-Johnson syndrome
Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, arthralgia, increased creatine kinase[Ref]
Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 2% of subjects.[Ref]
Hepatic
Frequency not reported: Increased indirect bilirubin[Ref]
Increased indirect bilirubin (up to 3 mg/dL above baseline) was reported in HIV-1/HCV-coinfected patients using this drug and an atazanavir/ritonavir-based antiretroviral regimen.[Ref]
