Harvoni

Harvoni is an oral tablet containing 90 mg ledipasvir and 400 mg sofosbuvir, approved in the EU for the treatment of chronic hepatitis C virus (HCV) genotype 1 and genotype 4 infections. It belongs to the antiviral class, combining an NS5A inhibitor (ledipasvir) with an NS5B polymerase inhibitor (sofosbuvir) to suppress viral replication. The fixed‑dose combination is administered once daily and is prescribed by healthcare professionals as part of a comprehensive HCV management plan.

Harvoni is indicated for the treatment of chronic hepatitis C virus infection in specific genotypes.

- Chronic HCV genotype 1 infection in adults. - Chronic HCV genotype 4 infection in adults. - Treatment of HCV infection in patients with compensated liver disease. - Use in patients with resistance‑associated substitutions when guided by a specialist. - Option for treatment‑naïve patients or those who have previously failed interferon‑based regimens.

The safety profile of Harvoni includes both frequently observed and less common adverse events.

Common: - Fatigue or tiredness. - Headache. - Nausea or upset stomach. - Insomnia or difficulty sleeping.

Serious: - Severe rash or skin reactions. - Hepatic decompensation or worsening liver function. - Bradycardia when co‑administered with amiodarone. - Elevated bilirubin levels.

Clinicians should evaluate several factors before prescribing Harvoni to ensure safe and effective use.

- Pregnancy status should be assessed; the safety in pregnancy is not established. - Baseline liver function tests are recommended to monitor hepatic health. - Renal impairment may require dosage consideration, especially in severe cases. - Presence of resistance‑associated substitutions may affect treatment outcome. - Co‑infection with HIV or HBV should be managed according to specialist guidance. - Adherence to the full treatment course is essential for viral eradication.

Harvoni may interact with other medicines, affecting its efficacy or safety.

Avoid: - Strong CYP3A4 inducers such as rifampin or St. John’s wort. - Certain antiretrovirals (e.g., efavirenz) that reduce drug exposure. - Amiodarone due to risk of serious bradycardia. - Anticonvulsants that induce hepatic enzymes.

Use with caution: - Antacids containing aluminum or magnesium; separate administration by at least 4 hours. - Proton pump inhibitors, which may lower ledipasvir absorption. - Statins (e.g., simvastatin, lovastatin) because of increased plasma concentrations. - HIV protease inhibitors that may increase sofosbuvir levels. - Herbal supplements that affect liver enzymes.