About the API
Ledipasvir and Sofosbuvir are antiviral agents, orally administered in a fixed-dose combination pill for the treatment of patients with chronic hepatitis C genotypes 1, 4, 5, and 6. Chronic hepatitis C (CHC) is a life threatening liver disease. The combination has a success rate of 93-100% after 12 weeks of treatment (depending on circumstances such as previous other treatment).
In the past, treatment regimens for CHC often included multiple medicines and weekly injectables, and were frequently difficult to tolerate. Ledipasvir and Sofosbuvir are taken once a day in a pill that has relatively mild side effects. The combination has also been proven effective in the treatment of CHC in patients co-infected with HIV.
In 2014, the fixed-dose combination Ledipasvir-Sofosbuvir was approved by the FDA under the trade name Harvoni for the treatment of chronic hepatitis C genotype 1 infection in adults. In 2015, the FDA expanded the approval of Ledipasvir-Sofosbuvir to include treatment of chronic hepatitis C genotypes 4, 5, and 6 and treatment of patients coinfected with HIV.