Investment Commentary, press release from Gilead Sciences below.
Gilead passes two Phase III tests with key hep C pill
Three down, one to go. Gilead Sciences ($GILD) met the main goals of two Phase III studies with its blockbuster hopeful sofosbuvir in patients with hepatitis C virus. The biopharma giant aims to use the results from the late-stage studies as part of a larger data package, which will go to the FDA later this year in the company's bid to advance the first all-oral attack on the liver-damaging disease
Read more: Fierce Biotech
Feb 4 (Reuters)
Gilead Sciences on Monday said two late-stage hepatitis studies have met their goals.
The studies, dubbed Fission and Neutrino, evaluated a 12-week course of once-daily nucleotide sofosbuvir in combination with ribavirin for the Fission study, and in combination with ribavirin and pegylated interferon for the Neutrino study.
The drugs were tested in patients who have chronic hepatitis C virus (HCV) infection and have never been treated for it.
In the Fission study, patients with HCV infection were selected at random to receive either a 12-week course of sofosbuvir plus ribavirin (RBV), or standard of care with 24 weeks of pegylated interferon alfa-2a (peg-IFN) plus RBV.
The study met its primary goal showing that the treatment was just as good as sofosbuvir plus RBV to peg-IFN plus RBV. In the study, 67 percent of patients achieved a sustained virologic response in the sofosbuvir plus RBV treatment group, versus 67 percent in the peg-IFN plus RBV treatment group.
Common adverse events - fatigue, headache, nausea, insomnia and dizziness - occurred more frequently in patients receiving peg-IFN and RBV compared with sofosbuvir and RBV.
In the Neutrino study, patients were given a 12-week course of sofosbuvir, RBV and peg-IFN. This study met its primary goal of achieving superiority, with 90 percent of patients in the study group showing a sustain response versus 60 percent in the control group.
The most common adverse events that occurred in bout 20 percent of patients in the Neutrino study were fatigue, headache, nausea, insomnia and anemia.
Gilead Announces Sustained Virologic Response Rates from Two Phase 3 Studies of Sofosbuvir for Hepatitis C
In the FISSION study, patients with genotype 2 or 3 HCV infection were randomized to receive either a 12-week course of sofosbuvir plus ribavirin (RBV) or standard of care with 24 weeks of pegylated interferon alfa-2a (peg-IFN) plus RBV. The study met its primary efficacy endpoint of non-inferiority of sofosbuvir plus RBV to peg-IFN plus RBV, with 67 percent (170/253) of patients achieving a sustained virologic response (SVR) in the sofosbuvir plus RBV treatment group versus 67 percent (162/243) in the peg-IFN plus RBV treatment group (95 percent CI for the difference: -7.5 to +8.0 percent for sofosbuvir plus RBV versus peg-IFN plus RBV; predefined criterion for non-inferiority was a lower bound of a two sided 95 percent CI of -15 percent).
All common adverse events (≥10 percent in any group) occurred more frequently in subjects receiving peg-IFN and RBV as compared to sofosbuvir and RBV. The most common adverse events in the sofosbuvir plus RBV arm occurring in ≥10 percent of the patients were fatigue, headache, nausea, insomnia and dizziness.
In the NEUTRINO study, patients with genotype 1, 4, 5 or 6 HCV infection were treated with a 12-week course of sofosbuvir, RBV and peg-IFN. This study met its primary efficacy endpoint of superiority compared to a predefined historic control SVR rate of 60 percent with 90 percent (295/327) of patients achieving SVR12 after completing therapy (P<0.001).
In the NEUTRINO study the most common adverse events that occurred in ≥20 percent of patients were fatigue, headache, nausea, insomnia and anemia.
“These data support the favorable clinical profile of sofosbuvir as the backbone of a potent, safe and well-tolerated treatment regimen that is effective across a broad range of HCV patient genotypes,” said
In FISSION, treatment-naïve HCV genotype 2 and 3 patients were randomized (1:1) to receive either 12 weeks of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day) (n=256) or 24 weeks of peg-IFN (180 μg/week) plus RBV (800 mg/day) (n=243). Overall, 20 percent of patients had compensated cirrhosis (advanced liver disease) and 72 percent had genotype 3 infection. The SVR12 rates in patients receiving sofosbuvir plus RBV were 97 percent for genotype 2 patients and 56 percent for genotype 3 patients. The SVR12 rates in patients receiving peg-IFN plus RBV in this study were 78 percent for genotype 2 patients and 63 percent for genotype 3 patients. Among patients with cirrhosis at baseline who received sofosbuvir/RBV, 47 percent achieved SVR12; 38 percent of cirrhotics who received peg-IFN plus RBV achieved SVR12.
With the exception of one patient who was non-compliant, all patients in the sofosbuvir/RBV arm became HCV negative on treatment and relapse accounted for the virologic failures.
Three patients (1 percent) receiving sofosbuvir discontinued treatment due to adverse events compared to 26 patients (11 percent) receiving peg-IFN/RBV.
In NEUTRINO, 327 treatment-naïve HCV genotype 1, 4, 5 and 6 patients were treated for 12 weeks with sofosbuvir 400 mg once daily in combination with RBV (1,000 or 1,200 mg/day) and peg-IFN (180 μg/week). Seventeen percent of patients had compensated cirrhosis and 89 percent were infected with genotype 1. Among genotype 1 patients, 89 percent achieved SVR12. Of the 35 patients with genotypes 4, 5 or 6, 97 percent achieved SVR12. Among patients with cirrhosis at baseline, 80 percent achieved SVR12. All patients in this study became HCV RNA negative on treatment and relapse accounted for all virologic failures.
Five patients (2 percent) receiving sofosbuvir in combination with peg-IFN and RBV discontinued treatment due to adverse events.
FISSION, NEUTRINO, POSITRON and FUSION are the pivotal Phase 3 studies designed to support an initial regulatory filing for sofosbuvir as part of all-oral therapy with RBV for genotype 2 and 3 treatment-naïve, treatment-experienced and interferon-intolerant HCV patients, and for sofosbuvir in combination with RBV and peg-IFN for genotype 1, 4, 5 and 6 treatment-naïve patients. Topline results from the POSITRON study were announced in November 2012, and topline results from the last Phase 3 study, FUSION, are anticipated later this quarter. Full results from all four studies will be presented at a future scientific conference.
Additional information about these and other ongoing clinical studies can be found at www.clinicaltrials.gov. Sofosbuvir is an investigational product and its safety and efficacy have not yet been established.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that the proportion of patients in the FISSION and NEUTRINO trials will not maintain SVR with longer follow up as favorable as the SVR12 rates reported in this press release. In addition, there is the possibility of unfavorable results from additional clinical trials involving sofosbuvir, including the FUSION trial. Further, we may not release topline results from the FUSION study or file for regulatory approval of sofosbuvir in the timelines currently contemplated. As a result, sofosbuvir may never be successfully commercialized. Further, Gilead may make a strategic decision to discontinue development of the compound if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended
Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)
Investment Commentary, press release from Gilead Sciences below.
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Sofosbuvir for Hepatitis C: Simpler, Shorter, Safer?
Olysio (simeprevir) - Resistant Variant (Q80K)
Simeprevir and Sofosbuvir-The Next Wave of Hepatitis C Treatment
Prescribing and patient information, FDA articles, videos and important updates
Simeprevir Approved In The United States
OLYSIO™ (simeprevir) Receives FDA Approval for Combination Treatment of Chronic Hepatitis C
Johnson & Johnson's protease inhibitor OLYSIO (Simeprevir) is approved for the treatment of HCV genotype 1, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non‑pegylated) with ribavirin.
Simeprevir was approved in Japan this past September , and in Canada on November 20th.
*Updated November 26:
HCV Drug Olysio (simeprevir) - The New Kid On The Block
OLYSIO (Simeprevir) Cost? - Janssen has priced Olysio at a wholesale acquisition price of $22,120 per bottle of 28 capsules (150 mg capsules), which is an approximately one-month supply. That's roughly $66,360 for a three-month course.
Lessons Learned - An important lesson we learned from these drugs may serve as a reminder for future DDAs, that is, once telaprevir and boceprevir were used in larger groups of patients, or in "real-life" settings - outside clinical trials, new response rates and adverse effects began to emerge.
Simeprevir drug–drug interactions - Simeprevir has a list of medications that can cause drug–drug interactions Other medications can interfere with the way DDAs are metabolized. The drug–drug interactions can either increase drug concentrations which may cause toxicity and lead to side effects, or decrease drug concentrations leading to a loss of efficacy.
Off Label Use - Simeprevir and Sofosbuvir? - Paul Sax, Editor-in-Chief at NEJM Journal Watch wrote an article this past summer on the possibility of combining simeprevir and sofosbuvir with or without ribavirin, to create an off label interferon-free regimen....
Important Safety Information
Olysio-simeprevir/Dosing & Uses, Drug Interactions, Adverse Effects
On November 22nd the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), supported Sovaldi® (sofosbuvir) for the Treatment of Chronic Hepatitis C
The CHMP opinion supports the approval of Sovaldi for the treatment of HCV in combination with other agents. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union (EU).
FDA Updates - Sofosbuvir
In October the Antiviral Drugs Advisory Committee recommend the approval of Gilead's Sofosbuvir, a nucleotide analog NS5B polymerase inhibitor in combination with just ribavirin for treating adult HCV genotypes 2/3 and in combination with pegylated interferon/ribavirin for genotype 1 and 4 treatment-naive patients.
The FDA does not have to follow the advice of its panels, but most often does. The U.S. health regulators are scheduled to decide whether to approve sofosbuvir by December 8th 2013
For detailed information please download the FDA review package for sofosbuvir and simeprevir.
FDA Updates For Sofosbuvir
FDA Updates For Simeprevir
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How Soon Should I Get Tested After Exposure ?
After the exposure (especially if the blood exposure involved another person known to have the hepatitis C virus), it is recommended that testing for the hepatitis C antibody be performed at 4 to 6 months after the exposure OR that testing for the hepatitis C virus itself (a test often called an HCV PCR or hepatitis C viral load test) be performed 4 to 6 weeks after the potential exposure. These tests are done to determine whether or not hepatitis C infection has occurred as a result of the exposure.;
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- New HCV Drugs
- Keeping current on the potential arrival of new improved hepatitis C drugs. As once a hepatitis C patient myself (I successfully treated the virus with standard HCV therapy in 2000) I understand the difficult decisions and overwhelming fear that ensues after being diagnosed with this serious and life-changing disease. This blog serves as a starting point for information on the rapidly evolving number of new agents in development to treat hepatitis C. Tina