Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Association for the Study of the Liver (APASL) meeting. SVR12 (HCV RNA undetectable 12 weeks after completing therapy) rates for Chinese HCV patients with genotype 1, 2, 3 or 6 ranged from 92-100 percent. The study evaluated Sovaldi in combination with ribavirin (RBV) or pegylated interferon+ribavirin (PegIFN+RBV) across a range of difficult-to-cure patient populations, including treatment-experienced patients and those with compensated cirrhosis. In this study, the safety profiles of the regimens were consistent with the known side effects of pegylated interferon and/or ribavirin. The most common adverse events were hematological abnormalities and pyrexia.
Note: this article has some errors about prior standard therapies. A better news article is here
Sofosbuvir (sold under the brand name Sovaldi from Gilead Sciences, among others) significantly reduces the risk of death and the need for liver transplant in patients with hepatitis C who suffer from advanced stages of liver disease.
A Brazilian study has shown that a medication currently used for Hepatitis C can help fight the Zika virus. According to the research, the antiviral Sofosbuvir inhibits virus replication. The group of Brazilian researchers has published their findings today, in the scientific journal Scientific Reports.
The study was conducted by scientists from Oswaldo Cruz Foundation and the Federal University of Rio de Janeiro.
According to Thiago Moreno, the head of the team, both the Zika and the Hepatitis C viruses have a common protein: RNA polymerase. Sofosbuvir inhibits the protein, preventing the Hepatitis C virus from replicating. “Indeed, we found that Sofosbuvir has the same effects with the Zika virus,” the researchers said.
The study sought to understand the effects of treatment with sofosbuvir-containing therapies on people requiring hemodialysis. Hemodialysis is a process of filtering the blood of a person when the kidneys are not working normally. This was a prospective study. Patients received sofosbuvir once daily (7 patients) or 3 times a week (5 patients) after hemodialysis treatment. Sofosbuvir was given with either simeprevir, daclatasvir, ledipasvir or ribavirin.
It was found that all of the patients tolerated the medications. Two relapses occurred in the 3 times a week group but no one relapse in the daily group.
It was found that sofosbuvir could be safely administered but that close monitoring should be given to hemodialysis patients. They also noted that more data is needed to safely and effectively treat hemodialysis patients.
HCV liver disease progression can increase the risk of severe kidney disease progression. It is important to have effective therapies to treat hepatitis C that are safe for people with severe kidney disease. In clinical trials, Zepatier was shown to be safe and effective in people with kidney disease and hepatitis C. Until more clinical studies are conducted on sofosbuvir containing therapies, Zepatier is a safe alternative to sofosbuvir containing therapies for people on hemodialysis.
The decision is a major blow to the access to drug movement, says MSF
In direct contradiction to its earlier order, the Controller General of Patents, Designs and Trademark granted American pharmaceutical company Gilead Sciences the patent for the blockbuster Hepatitis C drug Sofosbuvir (brand name Sovaldi) in India.
An application for the same patent was first rejected in January 2015 as lacking inventiveness and novelty.
In a new pilot study presented at The International Liver CongressTM in Barcelona, Spain, researchers reported a 90 percent cure rate of HCV using a new experimental antiviral treatment for six weeks.
Researchers from German HepNet Study-House gave a combination of sofosbuvir and ledipasvir to 20 HCV-positive patients once a day for 6 weeks. The risk factors of HCV infection among the 20 participants included sexual transmission, medical procedures/needle stick injury, drug use, and nail treatment complications.
“Given the high cost of sofosbuvir and ledipasvir, and the associated side effects that occur during treatment, we set out to assess whether shortened treatment duration could be an effective option for acute Hepatitis C patients,” said Katja Deterding from Hannover Medical School, Germany and study author in a statement in EurekAlert.
The once-daily, fixed-dose combination tablet elbasvir/grazoprevir (50 mg/100 mg) is more effective and safer than a commonly used regimen that includes sofosbuvir (400 mg) plus peginterferon and ribavirin in patients with chronic hepatitis C virus genotype 1 or genotype 4 infection, according to the results of a phase 3 trial released at the International Liver Congress 2016.
In the multi-center C-EDGE Head-to-Head study, investigators randomized 255 patients to 12 weeks of treatment with elbasvir (an NS5A inhibitor) plus grazoprevir (an NS3/4A protease inhibitor) or the NS5A inhibitor sofosbuvir plus peginterferon and ribavirin (PR).
The sofosbuvir plus PR regimen was recommended in guidelines at the start of the trial.