Ledipasvir (formerly GS-5885) is an experimental drug for the treatment of hepatitis C being developed by Gilead Sciences.[1] After completing Phase III clinical trials, on Feb 10, 2014 Gilead filed for U.S. Approval of a Ledipasvir/Sofosbuvir Fixed-Dose combination tablet for Genotype 1 Hepatitis C. [2][3] The Sovaldi (sofosbuvir) /Ledipasvir combination is a direct-acting antiviral agent that interferes with HCV replication and can be used to treat patients with genotypes 1a or 1b without peg-interferon.
Ledipasvir is an inhibitor of the hepatitis C virus HCV NS5A protein.
Data presented at the 20th Conference on Retroviruses and Opportunistic Infections in March 2013 showed that a triple regimen of the nucleotide analogue inhibitor sofosbuvir, ledipasvir, and ribavirin produced a 12-week post-treatment sustained virological response (SVR12) rate of 100% for both treatment-naive patients and prior non-responders with HCV genotype 1.[4][5] Gilead is developing a sofosbuvir + ledipasvir coformulation that is being tested with and without ribavirin. In February 2014 Gilead has filed for FDA approval of ledipasvir + sofosbuvir oral treatment, without interferon and ribavirin.[6]
References
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- ↑ Ledipasvir. United States Adopted Name
- ↑ Ledipasvir-submitted-to-FDA.
- ↑ GS-5885. Gilead Sciences
- ↑ ELECTRON: 100% Suppression of Viral Load through 4 Weeks’ Post-treatment for Sofosbuvir + Ledipasvir (GS-5885) + Ribavirin for 12 Weeks in Treatment-naïve and -experienced Hepatitis C Virus GT 1 Patients. Gane, Edward et al. 20th Conference on Retroviruses and Opportunistic Infections. March 3–6, 2013. Abstract 41LB.
- ↑ CROI 2013: Sofosbuvir + Ledipasvir + Ribavirin Combo for HCV Produces 100% Sustained Response. Highleyman, Liz. HIVandHepatitis.com. 4 March 2013.
- ↑ Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C. Gilead Sciences, 10. Februar 2014.