(Ledipasvir + sofosbuvir) is under clinical development by Gilead Sciences and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect (Ledipasvir + sofosbuvir)’s likelihood of approval (LoA) and phase transition for Hepatitis B took place on 21 Jun 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their (Ledipasvir + sofosbuvir) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

(Ledipasvir + sofosbuvir) overview

Ledipasvir and Sofosbuvir (Harvoni) is a a fixed dose combination drug belongs to anti-hepatitis C agent. It is formulated as granules, pellets, tablets and film coated tablets for oral route of administration. Harvoni is indicated for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infections. Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection which does not require administration with interferon or ribavirin. Harvoni is also indicated in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV. Harvoni plus ribavirin (RBV) for 12 weeks as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni is also indicated for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adolescents without cirrhosis or with compensated cirrhosis, 12 years of age and older, or weighing at least 35kg. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection. Harvoni is also indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. Harvoni is indicated for subjects with genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin and for subjects with genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin

Harvoni is under development for the treatment of hepatitis B infection globally.

Gilead Sciences overview

Gilead Sciences (Gilead) is a research-based biopharmaceutical company. It is engaged in the discovery, development and commercialization of medicines for the treatment of cardiovascular, hematological and respiratory diseases, inflammation, liver diseases, cancer and human immunodeficiency virus (HIV) infection. The company sells its products through subsidiaries and distributors in Europe, the Americas, Asia-Pacific, the Middle East and Africa. It has manufacturing facilities in Edmonton, Alberta, Canada; Foster City, San Dimas, Oceanside, California; and Cork, Ireland among others. The company has partnerships with universities, medical research institutions and global pharmaceutical leaders to develop new drugs. Gilead is headquartered in Foster City, California, the US.

Quick View (Ledipasvir + sofosbuvir) LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • (Ledipasvir + sofosbuvir)
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.