(Ledipasvir + sofosbuvir) is a Small Molecule owned by Gilead Sciences, and is involved in 79 clinical trials, of which 73 were completed, and 6 are ongoing.

Ledipasvir (GS 5885) is a NS5A inhibitor. NS5A is a pleiotropic protein that regulates viral RNA replication and modulation of the physiology of the host cell. The nonstructural protein 5A (NS5A) encoded by the human hepatitis C virus RNA genome binds directly to p53 and colocalizes it in the perinuclear region and inhibits transcriptional transactivation. The drug candidate by inhibiting NS5A protein prevents RNA replication and virion assembly. Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203) and incorporates into HCV RNA by the NS5B polymerase and acts as a chain terminator.

The revenue for (Ledipasvir + sofosbuvir) is expected to reach a total of $687m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the (Ledipasvir + sofosbuvir) NPV Report.

(Ledipasvir + sofosbuvir) was originated by Gilead Sciences and Pharmasset and is currently owned by Gilead Sciences.

(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.

The company reported revenues of (US Dollars) US$27,305 million for the fiscal year ended December 2021 (FY2021), an increase of 10.6% over FY2020. In FY2021, the company’s operating margin was 36.3%, compared to an operating margin of 16.5% in FY2020. In FY2021, the company recorded a net margin of 22.8%, compared to a net margin of 0.5% in FY2020. The company reported revenues of US$7,042 million for the third quarter ended September 2022, an increase of 12.5% over the previous quarter.

Quick View – (Ledipasvir + sofosbuvir)

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

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.