What is the efficacy of ledipasvir/sofosbuvir (Harvoni) in the treatment of hepatitis C (hep C) infection?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Several anti-hepatitis C agents are currently approved by FDA for treatment as described below.

◊ Ledispasvir/sofosbuvir (Harvoni)

Harvoni is a combination oral product containing ledipasvir, an NS5A protein inhibitor, and sofosbuvir that was approved by the FDA in October 2014 for the treatment of HCV genotype 1. Since its original approval in the United States, the indication has been expanded to include genotypes 1, 4, 5, and 6. It is administered once daily and does not need to be administered with IFN. Some regimens may require ribavirin. Studies have shown a high SVR (94%-99%) in all treatment groups (ie, treatment naïve or treatment experienced, with or without cirrhosis, and liver transplant recipients). [111, 112, 113]

This fixed-dose combination drug demonstrated efficacy in refractory cirrhotic hepatitis C. In a study of 154 patients with cirrhotic chronic HCV infection whose condition had failed previous protease inhibitor–based therapy, treatment with the fixed-dose combination of ledipasvir and sofosbuvir with or without ribavirin led to an SVR in the majority of patients. [114, 115] Study subjects received either ledipasvir and sofosbuvir plus placebo for 24 weeks or placebo for 12 weeks followed by ledipasvir and sofosbuvir plus ribavirin for 12 weeks. SVR12 was seen in 96% of the 24-week combination group and 97% of the 12-week combination plus ribavirin group. Three patients in the 12-week group and two patients in the 24-week group experienced relapses. [114, 115]

For treatment-naïve noncirrhotic patients, with chronic HCV and a viral load below 6 million international units/mL (IU/mL), treatment duration is generally 8 weeks. However, with a viral load above 6 million IU/mL or  with cirrhosis, ledispasvir/sofosbuvir is given for 12 weeks. In patients with and without cirrhosis, this therapy results in SVR rates greater than 95%. [110, 116]

In a trial of 20 patients with acute hepatitis C genotype 1 monoinfection, a 6-week treatment regimen with ledipasvir plus sofosbuvir resulted in SVR in all patients. [117] Treatment was well tolerated; there were no drug-related serious adverse events.

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