The fixed-dose combination of ledipasvir-sofosbuvir provides an effective and well-tolerated one-pill once-a-day option for treatment of genotypes 1, 4, 5, and 6 chronic hepatitis C (HCV) infection. This direct-acting antiviral regimen was the first FDA-approved interferon- and ribavirin-free regimen to treat hepatitis C. Ledipasvir-sofosbuvir can be used without ribavirin in most patients with genotype 1A, except those who are cirrhotic and treatment-experienced. In addition, patients who are treatment-naïve, not black, and without cirrhosis may be eligible for an 8-week duration which has been found in clinical trials and observational studies to be as effective as 12 weeks. Like sofosbuvir-velpatasvir, the other NS5B-NS5A inhibitor combination, it has been shown to be safe and efficacious in patients with decompensated cirrhosis.


Ledipasvir is a potent inhibitor of HCV NS5A, a viral phosphoprotein that plays an important role in viral replication, assembly, and secretion. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase—the key enzyme mediating HCV RNA replication. The triphosphate form of sofosbuvir (GS-461203) mimics the natural cellular uridine nucleotide and is incorporated by the HCV RNA polymerase into the elongating RNA primer strand, resulting in viral chain termination.


Figure 1. Bottle – Ledipasvir-sofosbuvir (Harvoni)The fixed-dose combination of ledipasvir and sofosbuvir (Harvoni) (Figure 1) is manufactured by Gilead Sciences.


The wholesale acquisition cost (WAC) for ledipasvir-sofosbuvir is $1125 per pill.

  • Cost of 8-week course of therapy = $63,000
  • Cost of 12-week course of therapy = $94,500
  • Cost of 24-week course of therapy = $189,000

Gilead Sciences has an active ledipasvir-sofosbuvir patient assistance program for eligible patients with hepatitis C who do not have insurance and do not have coverage through Medicaid or Medicare. Information regarding the Gilead Sciences ledipasvir-sofosbuvir (Harvoni) patient assistance program can be obtained at the Support Path for Solvaldi and Harvoni web site and by contacting them directly by phone at 1-855-769-7284 (hours of operation Monday through Friday between 9:00 am and 8:00 pm Eastern Time).


Available data from clinical trials has demonstrated the combination of ledipasvir-sofosbuvir has been very well tolerated. The most common reported adverse effects are fatigue and headache.


Ledipasvir-sofosbuvir has significant drug-drug interactions with P-gp inducers (e.g., St. John’s wort and rifampin). The concomitant use of ledipasvir-sofosbuvir with P-gp inducers is not recommended. Additional drug-drug interactions may occur with ledipasvir-sofosbuvir and other medications and these are detailed in the Ledipasvir-sofosbuvir (Harvoni) Full Prescribing Information.For complete information on ledipasvir-sofosbuvir-related drug interactions, see the Drug Interactions section in the Ledipasvir-Sofosbuvir (Harvoni) Prescribing Information.