Applies to sofosbuvir: oral film-coated tablets, oral pellets.
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 (See Risk of HBV Reactivation in Patients Coinfected with HCV and HBV under Cautions.)
- Test all patients for evidence of current or prior HBV infection before initiating sofosbuvir.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 in conjunction with ribavirin (≥20%): Fatigue, headache, decreased appetite.
Sofosbuvir in conjunction with peginterferon alfa and ribavirin (≥20%): Fatigue, headache, nausea, insomnia, anemia.
For Healthcare Professionals
Applies to sofosbuvir: oral pellet, oral tablet.
General
When this drug is used with ribavirin or peginterferon alfa/ribavirin, the respective manufacturer product information should be consulted for associated side effects.
The most common side effects reported with sofosbuvir and ribavirin therapy were fatigue and headache. The most common side effects reported with sofosbuvir, peginterferon alfa, and ribavirin therapy were fatigue, headache, nausea, insomnia, and anemia. Therapy was permanently discontinued due to side effects in up to 4% of subjects using placebo, up to 1% of subjects using sofosbuvir and ribavirin for 12 weeks, less than 1% of subjects using sofosbuvir and ribavirin for 24 weeks, 11% of subjects using peginterferon alfa and ribavirin for 24 weeks, and 2% of subjects using sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks.[Ref]
Other
Very common (10% or more): Fatigue (up to 59%), asthenia (up to 21%), pyrexia (up to 18%), chills (up to 17%), influenza-like illness (up to 16%), pain
Common (1% to 10%): Chest pain[Ref]
Nervous system
Very common (10% or more): Headache (up to 36%), dizziness
Common (1% to 10%): Disturbance in attention, migraine, memory impairment[Ref]
Gastrointestinal
Increased lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in up to 2% of patients. Lipase elevation was isolated and asymptomatic.[Ref]
Very common (10% or more): Nausea (up to 34%), diarrhea (up to 12%), vomiting
Common (1% to 10%): Increased lipase, abdominal discomfort, constipation, dyspepsia, dry mouth, gastroesophageal reflux[Ref]
Hematologic
Decreased hemoglobin (less than 10 g/dL: up to 23%; less than 8.5 g/dL: up to 2%), decreased neutrophils (0.5 to less than 0.75 x 10[9]/L: up to 15%; less than 0.5 x 10[9]/L: up to 5%), and decreased platelets (25 to less than 50 x 10[9]/L: up to 1%) have been reported.
In a study in liver transplant recipients, decreased hemoglobin was very common during therapy. Hemoglobin decreased to less than 10 g/dL in 13 of 40 patients (32.5%); hemoglobin decreased to less than 8.5 g/dL in 1 of those patients. Epoetin and/or a blood product was used in 8 patients (20%); 5 patients (12.5%) discontinued, modified, or interrupted therapy due to side effects.
Pancytopenia was reported, particularly in patients using concomitant pegylated interferon.[Ref]
Very common (10% or more): Decreased hemoglobin (up to 32.5%), anemia (up to 21%), neutropenia (up to 17%), decreased neutrophils (up to 15%), decreased lymphocyte count, decreased platelet count
Uncommon (0.1% to 1%): Pancytopenia[Ref]
Dermatologic
Very common (10% or more): Pruritus (up to 27%), rash (18%)
Common (1% to 10%): Alopecia, dry skin
Frequency not reported: Stevens-Johnson syndrome
Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]
Psychiatric
Severe depression was reported, particularly in patients with history of psychiatric illness.[Ref]
Very common (10% or more): Insomnia (up to 25%), irritability (up to 13%)
Common (1% to 10%): Depression, anxiety, agitation
Uncommon (0.1% to 1%): Severe depression (including suicidal ideation, suicide)[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 this drug.[Ref]
Frequency not reported: Severe bradycardia, heart block
Postmarketing reports: Symptomatic bradycardia (including cases requiring pacemaker intervention)[Ref]
Metabolic
Very common (10% or more): Decreased appetite (up to 18%)
Common (1% to 10%): Decreased weight[Ref]
Musculoskeletal
Very common (10% or more): Myalgia (up to 14%), arthralgia
Common (1% to 10%): Increased creatine kinase, back pain, muscle spasms[Ref]
Increased creatine kinase (at least 10 x ULN) was reported in up to 2% of patients. Creatine kinase elevation was isolated and asymptomatic.[Ref]
Respiratory
Very common (10% or more): Dyspnea, cough
Common (1% to 10%): Nasopharyngitis, exertional dyspnea[Ref]
Hepatic
Common (1% to 10%): Increased total bilirubin
Postmarketing reports: Hepatitis B reactivation[Ref]
Increased total bilirubin (greater than 1.5 x ULN) was reported in up to 3% of patients. Bilirubin levels peaked during the first 1 to 2 weeks of therapy then decreased and returned to baseline levels by 4 weeks after therapy. These bilirubin elevations were not associated with transaminase elevations.[Ref]
Ocular
Common (1% to 10%): Blurred vision[Ref]
