Harvoni (Ledipasvir, Sofosbuvir)

Harvoni is approved for several chronic hepatitis C indications, reflecting its activity against multiple genotypes.

• Treatment of chronic HCV genotype 1 infection in adults.
• Treatment of chronic HCV genotype 4 infection.
• Treatment of chronic HCV genotype 5 infection.
• Treatment of chronic HCV genotype 6 infection.
• Use in patients with compensated liver disease, including cirrhosis.
• Option for both treatment‑naïve and treatment‑experienced individuals.

Adverse events reported with Harvoni vary in frequency; most are mild to moderate, while rare serious reactions may occur.

Common

• Fatigue
• Headache
• Nausea
• Diarrhea

Serious

• Hepatic decompensation in patients with advanced cirrhosis
• Severe allergic reactions such as rash or angioedema
• Elevated serum transaminases

Clinicians should evaluate several safety considerations before initiating Harvoni therapy.

• Assess liver function; avoid use in patients with decompensated cirrhosis.
• Review renal function; dose adjustment is not required but monitor in severe impairment.
• Pregnancy status should be confirmed; safety data are limited.
• Co‑administration with strong enzyme inducers may reduce efficacy.
• Monitor for signs of hepatitis flare or hepatic failure during treatment.
• Counsel patients on adherence to the full treatment course.
• Evaluate for potential drug‑resistance mutations in prior therapy failures.

Harvoni interacts with several medicines that affect its absorption or antiviral activity.

Avoid

• Strong CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John’s wort.
• Amiodarone (risk of serious bradycardia when co‑administered).
• Antiretroviral agents that are potent inducers of P‑gp or BCRP.

Use with caution

• Antacids containing aluminum or magnesium; separate dosing by at least 4 hours.
• Certain statins (e.g., simvastatin, lovastatin) due to increased exposure.
• HIV protease inhibitors; monitor for possible pharmacokinetic changes.