Harvoni

Harvoni is generally well tolerated, and very few people discontinue treatment due to side effects. The most commonly reported side effects are fatigue, headache, nausea, diarrhea and insomnia, all considered to be mild. Additional side effects observed in people with decompensated cirrhosis or after liver transplant were thought to be due to their medical condition rather than the medication. Rapid reduction in hepatitis C viral load during direct-acting antiviral therapy (DAA) may lead to improvement in glucose metabolism in people with diabetes, potentially resulting in symptomatic hypoglycemia if anti-diabetic medications are continued at the same dose. People with diabetes should be monitored for changes in glucose tolerance, particularly within the first three months. Modification of antidiabetic therapy may be necessary. Hepatic decompensation and hepatic failure (including fatal cases) have been reported, typically occurring within the first four weeks of starting treatment. Most people with severe outcomes had either advanced liver disease with moderate or severe hepatic impairment prior to treatment initiation or compensated cirrhosis with mild liver impairment at baseline but with a prior decompensation event (e.g., history of ascites, variceal bleeding or encephalopathy). Additionally, rare cases have been reported in people without cirrhosis or with compensated cirrhosis (often with evidence of portal hypertension) with concomitant use of medications that are not recommended, or in individuals with other confounding factors (such as serious liver-related medical or surgical comorbidities). In individuals with compensated cirrhosis (Child-Pugh class A), transient elevations in bilirubin (<2 ULN) without concurrent elevations in liver enzymes (ALT/AST) may occur early in treatment (generally within the first two weeks); this usually resolves with continued treatment. Liver function test results should be monitored as clinically indicated in individuals with compensated cirrhosis (Child Pugh class A) or with evidence of advanced liver disease (e.g., portal hypertension). Treatment will be discontinued in people who develop signs or symptoms of hepatic decompensation/failure. Harvoni has not been studied in pregnant or nursing individuals, so its impact on fetal development or nursing babies is unknown. Pregnant persons or anyone trying to become pregnant should avoid use if the addition of ribavirin is required. See the Ribavirin Page

See “Black Box Warning” on hepatitis B testing and treatment.