Ledipasvir is a drug for the treatment of hepatitis C that was developed by Gilead Sciences.[1] After completing Phase III clinical trials, on February 10, 2014, Gilead filed for U.S. approval of a ledipasvir/sofosbuvir fixed-dose combination tablet for genotype 1 hepatitis C.[2][3] The ledipasvir/sofosbuvir 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 or ribavirin.
Ledipasvir is an inhibitor of NS5A, a hepatitis C virus protein.[citation needed]
Data presented at the 20th Conference on Retroviruses and Opportunistic Infections in March 2013 showed that a triple regimen of the nucleotide analog 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] The sofosbuvir/ledipasvir coformulation is being tested with and without ribavirin. In February 2014 Gilead filed for United States Food and Drug Administration (FDA) approval of ledipasvir/sofosbuvir oral treatment, without interferon and ribavirin.[6]
On 10 October 2014 the FDA approved the combination product ledipasvir/sofosbuvir called Harvoni.[7]
^"Ledipasvir" (PDF). United States Adopted Name. Archived from the original (PDF) on 2016-01-31. Retrieved 2013-05-14.
^"Ledipasvir-submitted-to-FDA".
^"GS-5885". Gilead Sciences. Archived from the original on 2013-04-10. Retrieved 2013-03-08.
^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 Archived 2013-03-23 at the Wayback Machine. 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 Archived 2015-09-24 at the Wayback Machine. 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 February 2014.
^"U.S. Food and Drug Administration Approves Gilead's Harvoni (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C". 10 October 2014. Archived from the original on 12 October 2018. Retrieved 10 October 2014.
Ledipasvir is a drug for the treatment of hepatitis C that was developed by Gilead Sciences. After completing Phase III clinical trials, on February 10...
hepatitis B in those who have been previously infected. In combination with ledipasvir, daclatasvir or simeprevir, it is not recommended with amiodarone due...
Wong, David K.; Dieterich, Douglas; Sulkowski, Mark (August 20, 2015). "Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1". New England...
glecaprevir/pibrentasvir or ledipasvir/sofosbuvir (with the aforementioned limitations for the latter as above) or 12 weeks of elbasvir/grazoprevir, ledipasvir/sofosbuvir...
(sofosbuvir) and Ledifos (a fixed-dose combination of sofosbuvir and ledipasvir).[citation needed] Hetero Group's subsidiaries include Hetero Drugs, Hetero...
HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19, including ledipasvir/sofosbuvir and sofosbuvir. Gilead is a member of the NASDAQ Biotechnology...
care providers about nine people that began taking its hepatitis C drugs ledipasvir/sofosbuvir or sofosbuvir along with amiodarone, daclatasvir, or simeprevir...
telaprevir, boceprevir, simeprevir, and others NS5A inhibitors, including ledipasvir, daclatasvir, and others NS5B inhibitors, including sofosbuvir, dasabuvir...
been approved, among them notably the first FDA-approved NS5A inhibitor ledipasvir, approved October 2014 in combination with sofosbuvir to comprise the...
healthcare providers about people who began taking the hepatitis C drugs ledipasvir/sofosbuvir or sofosbuvir along with amiodarone, who developed abnormally...
obtain legal access to generic versions of sofosbuvir, daclatasvir, and ledipasvir. At EASL International Liver Congress, Dr. Freeman presented data showing...
Susanna Naggie; Curtis Cooper; Michael Saag; et al. (21 July 2015). "Ledipasvir and Sofosbuvir for HCV in Patients Coinfected with HIV-1". The New England...
rapidly after the introduction in 2014 of sofosbuvir and the combination ledipasvir/sofosbuvir, drugs that cured hepatitis C, and whose market was also diminishing...
granulomatous dermaititis is associated with subacute bacterial endocarditis, ledipasvir/sofosbuvir, allopurinol, Hodgkin’s and non-Hodgkin’s lymphoma, chronic...
overwhelming superiority of newer direct-acting antiviral agents, such as ledipasvir/sofosbuvir. The SPRINT-1 trial was a phase-II trial of boceprevir in difficult-to-treat...
variant are less likely to respond to NS5A inhibitors such as daclatasvir, ledipasvir and ombitasvir, which are commonly used in popular DAA regimens (e.g....
development terminated. Sofosbuvir (Sovaldi; Harvoni (combination with ledipasvir)): nucleotide analog, approved by the FDA in December 2013. Gehring S...
they are often used in combination with NS5B inhibitors: FDA-approved: Ledipasvir, approved on October 10, 2014 in a fixed-dose combination (FDC) with sofosbuvir...
cirrhosis provided an overall SVR12 of 93% (14 out of 15 individuals). Ledipasvir/Sofosbuvir The multi-center, open-label, ION-4 Study showed that a 12-week...
virus. It has high efficacy in combination with several other drugs, like ledipasvir, either with or without peginterferon-alfa. It has many advantages due...
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