Part I: Summary of Product Information
... HCV/HBV (hepatitis b virus) co-infection There are no data on the use of Gratisovir in patients with HCV/HBV coinfection. Paediatric population Gratisovir is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this po ...
... HCV/HBV (hepatitis b virus) co-infection There are no data on the use of Gratisovir in patients with HCV/HBV coinfection. Paediatric population Gratisovir is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this po ...
NEWS YOU CAN USE 2015 03 UPD
... Type 1 and Type 2 diabetes • Same active ingredient as Lantus, but at three ...
... Type 1 and Type 2 diabetes • Same active ingredient as Lantus, but at three ...
New Drug Update 2015
... * = All treatment groups had SVR rates superior to adjusted historical response rate of 25% (p<0.001 for all ...
... * = All treatment groups had SVR rates superior to adjusted historical response rate of 25% (p<0.001 for all ...
Clinically Significant Drug-Drug Interactions Between - IAS-USA
... Of note, absorption of ledipasvir is pH dependent. Antacid doses should be separated from ledipasvir/sofosbuvir doses by 4 hours. Doses of histamine type 2 receptor blockers should not exceed the equivalent of famotidine 40 mg twice daily. There are conflicting data on whether use of proton pump inh ...
... Of note, absorption of ledipasvir is pH dependent. Antacid doses should be separated from ledipasvir/sofosbuvir doses by 4 hours. Doses of histamine type 2 receptor blockers should not exceed the equivalent of famotidine 40 mg twice daily. There are conflicting data on whether use of proton pump inh ...
Merck`s Zepatier shows high response rates in hep C trials
... taking an opioid agonist therapy such as methadone or buprenorphine. Data show that 94 percent and 96 percent of patients achieved SVR24 in the blinded and open-label arms of the trial, respectively. The analysis of 296 patients showed six probable HCV reinfections occurred, representing an incidenc ...
... taking an opioid agonist therapy such as methadone or buprenorphine. Data show that 94 percent and 96 percent of patients achieved SVR24 in the blinded and open-label arms of the trial, respectively. The analysis of 296 patients showed six probable HCV reinfections occurred, representing an incidenc ...
Physician Views: What Opportunity for Gilead Sciences' Hepatitis C Therapy
... Analysts expect positive recommendation to be followed by approval in late 2013/early 2014. As a potential first-in-class NS5B polymerase inhibitor, sofosbuvir is broadly expected to act as a key backbone therapy for oral, interferon-free treatment regimens that emerge from 2015 onwards (including G ...
... Analysts expect positive recommendation to be followed by approval in late 2013/early 2014. As a potential first-in-class NS5B polymerase inhibitor, sofosbuvir is broadly expected to act as a key backbone therapy for oral, interferon-free treatment regimens that emerge from 2015 onwards (including G ...
Sofosbuvir
Sofosbuvir (brand names Sovaldi, Hepcinat, Resof, Hepcvir, SoviHep) is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection. It has been marketed since 2013. Compared to previous treatments, sofosbuvir-based regimens provide a higher cure rate, fewer side effects, and a two- to four-fold reduced duration of therapy. Sofosbuvir allows most patients to be treated successfully without the use of peginterferon, an injectable drug with severe side effects that is a key component of older drug combinations for the treatment of HCV.Sofosbuvir inhibits the RNA polymerase that the hepatitis C virus uses to replicate its RNA. It was discovered at Pharmasset and developed by Gilead Sciences.In 2013, the FDA approved sofosbuvir in combination with ribavirin (RBV) for oral dual therapy of HCV genotypes 2 and 3, and for triple therapy with injected pegylated interferon (pegIFN) and RBV for treatment-naive patients with HCV genotypes 1 and 4. In 2014 a combination of sofosbuvir with the viral NS5A inhibitor ledipasvir was approved. This latter combination provides high cure rates in people infected with genotype 1 (the most common subtype in the U.S., Japan, and much of Europe) without the use of interferon, irrespective of prior treatment failure or the presence of cirrhosis.The price of sofosbuvir, quoted in various media sources as $84,000 to $168,000 for a course of treatment in the U.S., £35,000 in the UK for 12 weeks has engendered considerable controversy. In September 2014, Gilead announced that it would permit generic manufacturers to sell sofosbuvir in 91 developing countries and that it would sell a name brand version of the product in India for approximately $300 per course of treatment.It is on the World Health Organization's List of Essential Medicines, a list of the most important medications needed in a basic health system.