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Drugs in Development / Clinical Trials—Updated October 13, 2014
Thursday, November 20, 2014
The Economic Committee for Health Products (CEPS) has fixed the price of a box of Sovaldi at 13,667 euros before tax, a reduction of 5,000 euros on the original price and "the lowest price in Europe", the Health Ministry said on Thursday.
Twelve weeks of treatment will now cost 41,000 euros ($51,373) before tax, against 56,000 euros previously.
Revolutionary new treatments have hit the market in just the last few months. But they’re so expensive health insurers are balking at the price.
Part four of our series “At the Crossroads: The Rise of Hepatitis C and the Fight to Stop it” looks at the high cost of these new treatments and who’s paying for them.
Listen to the podcast and read the transcript here....
Findings from this vanguard study will inform the design parameters of a larger, more rigorous evaluation in an R01 application, if results are promising. The PREP-C web-based assessment and intervention package is designed to be scalable and can be disseminated through the live PrepC.org web site. The proposed study is innovative in that it seeks to develop the first web-based intervention for health care providers to use to increase HCV treatment initiation in HIV/HCV-co-infected persons. The study can have a major public health impact by providing needed structured resources for health care providers to increase rates of HCV treatment initiation in HIV/HCV-co-infected persons, thereby reducing mortality due to end-stage liver disease.
—Cheryl Reitz, MA, & CD Mazoff, PhD
Other numbers that have been derived from the collected surveys are:
69% of injection drug users in Canada have hepatitis C (2005-2008).
28% of Canada’s 15,000 prison inmates have hepatitis C [adjusted for 2014].
5% of gay and MSM have hepatitis C (2005-2008).
5% of street-involved youth have hepatitis C (2005-2006).
3% of 850,000 First Nations people have hepatitis C [adjusted for 2014].
3% of Canada’s immigrant population is HCV positive [adjusted for 2014].3
Canada has no “National Strategy” for dealing with hepatitis C, and the Federal and Provincial governments often (as in the United States) have different agendas and do not work together well.
1. Factor 8: The Arkansas Prison Blood Scandal, a film by Kelly Duda, Review by C.D. Mazoff: HCV Advocate, March 2007, p.7. http://hcvadvocate.org/news/newsLetter
2. Hepatitis C in Canada:2005-2010 Surveillance Report. Public HealthAgency of Canada; 2011.
3.The epidemiology of hepatitis C in Canada (CATIE 2013) http://www.catie.ca/en/fact-sheets/epidemiology
4. Liver Disease in Canada: A Crisis in the Making: An Assessment of Liver Disease in Canada Published by the Canadian Liver Foundation in March, 2013. http://www.liver.ca/files/PDF/Liver_Disease_Report
5. Deal With It: Untold Stories of Hepatitis C in Canada. Bang Albino Films, 2014
6.Liver Cancer on the Rise: Canadian Cancer Society 2013 http://www.cancer.ca/en/about-us/for-media/media-releases /national/2013/liver-cancer-on-the-rise-cancer-statistics/?region=bc
Cheryl Reitz is on the Board of Directors of HepCBC and HepCBC’s representative on the Executive of Action Hepatitis Canada; C.D. Mazoff, the Managing Editor & Webmaster of the HCV Advocate, is a former Executive Director of HepCBC where he currently sits on the Board.
Tuesday, November 18, 2014
Manufactured by Gilead, Sofosbuvir was licenced for use late last year. And in April this year, NHS England took the unusual step of setting up a special access scheme so patients with less than a year to live were able to be treated without waiting for the National Insitute for Health and Care Excellence (Nice) to evaluate whether it should become routinely available on the NHS.
But it is expensive – £35,000 for a 12 week course. So now NHS England is balking at the potential cost. In fact so much so, this programme has learned that they have asked Nice to delay implementation.
- See more at: http://blogs.channel4.com/victoria-macdonald-on-health-and-social-care/nhs-asks-nice-delay-groundbreaking-hepatitis-drug/2625#sthash.Kiw2q4xS.dpuf
European Commission Grants Marketing Authorization for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir), the First Single Tablet Regimen to Treat the Majority of Chronic Hepatitis C Patients With Genotype 1 and 4
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 18, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Harvoni® (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults. Harvoni combines the NS5A inhibitor ledipasvir (LDV) with the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved by the European Commission under the tradename Sovaldi® in January 2014.
Harvoni is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and is recommended in treatment-naïve and treatment-experienced cirrhotic and non-cirrhotic genotype 1 and 4 patients with a treatment duration of 12 or 24 weeks depending on prior treatment history and cirrhosis status. Eight weeks of treatment with Harvoni may be considered in non-cirrhotic treatment-naïve genotype 1 patients. In genotype 1 and 4 patients with decompensated cirrhosis, and genotype 3 patients with cirrhosis and/or prior treatment failure, Harvoni should be used in combination with ribavirin for 24 weeks. Harvoni is also indicated for patients with HCV who have HIV co-infection.
Today’s marketing authorization is based on the clinical development program that included more than 2,000 patients with HCV infection, and follows an accelerated assessment by the European Medicines Agency, a designation that is granted to new medicines of major public health interest. It allows for the marketing of Harvoni in all 28 countries of the European Union (EU).
“Genotype 1 patients living with hepatitis C in Europe and the physicians who treat them have been waiting for a treatment advance like this for decades,” said Graham Foster, MD, Professor of Hepatology, Queen Mary University of London. “With Harvoni, we have the potential to transform the way we treat people living with the most prevalent form of hepatitis C in Europe. We can now expect very high SVR rates, and for many patients, we can eliminate the need for interferon injections and ribavirin and offer a cure in a once-daily tablet.”
The marketing authorization is supported primarily by data from three Phase 3 studies, ION-1, ION-2 and ION-3. These studies evaluated eight, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.
These studies included non-cirrhotic treatment-naïve patients (ION-3), cirrhotic and non-cirrhotic treatment-naïve patients (ION-1) and cirrhotic and non-cirrhotic patients who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor (ION-2).
The primary endpoint for each study was sustained virologic response (HCV undetectable) 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV. In these studies, ribavirin was not shown to increase response rates. Trial participants in the ribavirin-free arms (n=1,080) achieved SVR12 rates of 94 to 99 percent.
The approval was also supported by preliminary data from the SOLAR-1 trial, which evaluated difficult to treat patients with decompensated cirrhosis and patients who have undergone liver transplantation, and from the ERADICATE trial, which evaluated genotype 1 HCV patients co-infected with HIV. The primary endpoint in these studies was SVR12. At the time of submission, only preliminary results were available. In the SOLAR-1 trial, participants with decompensated cirrhosis receiving a 12-week treatment regimen of Harvoni plus ribavirin had an SVR4 rate of 90 percent (n=45/50). In post-liver transplant patients without decompensated liver disease, SVR4 rates were greater than 95 percent (n=109). In an interim analysis of the ERADICATE trial, 40 of the 50 patients had reached 12 weeks post treatment and had SVR12 rates of 98 percent (n=39/40).
The ELECTRON-2 trial, a Phase 2 open-label study, provided preliminary data on genotype 3 infected HCV patients demonstrating 100 percent (n=26/26) SVR12 when Harvoni was used in combination with ribavirin for 12 weeks.
In these clinical studies, fatigue and headache were more common in patients treated with Harvoni compared to placebo.
Harvoni was approved by the U.S. Food and Drug Administration and Health Canada in October 2014 and in New Zealand in November 2014. Regulatory submissions for Harvoni are pending in Japan and Switzerland. Sovaldi as a single agent is approved for use in the European Union and in the United States, Canada, Australia, New Zealand, Egypt, Switzerland and Turkey.
Important Safety Information
The summary of product characteristics of co-prescribed medicinal products should be consulted before starting therapy with Harvoni.
- Harvoni should not be administered concomitantly with other medicinal products containing sofosbuvir.
- In clinical studies, fatigue and headache were more common in patients treated with Harvoni compared to placebo.
- Contraindications include hypersensitivity to the active substances or to any of the excipients. Co-administration with rosuvastatin or St. John’s wort (Hypericum perforatum) is contraindicated. Co-administration with certain P-glycoprotein (P-gp) inducers (e.g. rifampicin, carbamazepine and phenytoin) is not recommended. Monitoring of digoxin and dabigatran is recommended when used with Harvoni. Caution and frequent renal monitoring is recommended for co-administration with certain HIV antiretroviral regimens.
- Safety has not been established in patients with severe renal impairment. For patients on statins dose reduction should be considered and careful monitoring for statin adverse events (myopathy and rhabdomyolysis) should be undertaken. A Summary of Product Characteristics is available at www.ema.europa.eu.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.
- See more at: http://gilead.com/news/press-releases/2014/11/european-commission-grants-marketing-authorization-for-gileads-harvoni-ledipasvirsofosbuvir-the-first-single-tablet-regimen-to-treat-the-majority-of-chronic-hepatitis-c-patients-with-genotype-1-and-4#sthash.YcamaUon.dpuf
Their findings, note the researchers, may contribute to more effective development of hepatitis C drugs in the future and to more personalized treatment for patients.
In this new study, Mount Sinai researchers examined HCV response to an experimental treatment that targets and blocks the supply of a microRNA (miR-122) that the virus needs for infection of human cells. Contrary to expectations, they found that depleting the supply of miR-122 could trigger drug resistance with the emergence of HCV strains able to infect cells with negligible levels of the microRNA. This information could be used for more effective dosing of drugs targeting this gene, as well as for pre-treatment analysis to determine which patients may respond best to this class of drugs.