Harvoni

Harvoni is the brand name for a fixed-dose combination tablet containing sofosbuvir and ledipasvir, two direct-acting antiviral agents used to treat chronic hepatitis C virus (HCV) infection. Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, and ledipasvir inhibits the NS5A protein; together they interfere with viral replication and assembly.

The therapy is approved for adults and certain pediatric patients with chronic HCV infection, covering several genotypes, most notably genotype 1, with or without cirrhosis. The standard regimen is a single tablet taken once daily, with the treatment duration typically ranging from 8 to 12 weeks, depending on genotype, prior treatment history, and liver cirrhosis status. Harvoni is often used without the need for interferon or ribavirin.

Clinical efficacy, measured by sustained virologic response (SVR) 12 weeks after treatment (SVR12), is high in approved populations, with SVR rates commonly around 95% for genotype 1 and favorable responses for other genotypes when used as indicated. Resistance to Harvoni is uncommon, contributing to durable viral clearance in most patients.

Common adverse events are generally mild and include fatigue and headache; some patients may experience nausea, diarrhea, or insomnia. Serious adverse events are rare but can occur, and caution is advised in patients with decompensated liver disease or concomitant liver conditions. Drug interactions exist, including reduced levels from certain acid-reducing drugs or P-glycoprotein inducers, and potential bradycardia when used with amiodarone. Patients should be screened for hepatitis B coinfection, as HBV reactivation can occur after HCV clearance.

Harvoni was developed by Gilead Sciences and approved by regulatory authorities in 2014, contributing to high cure rates and shorter, simpler regimens for chronic HCV infection. Pricing and access vary by country and payer.