Most states violate federal Medicaid law because they deny coverage
for sofosbuvir, a new and highly effective treatment to cure hepatitis C, according to Lynn E. Taylor, M.D., director of The Miriam Hospital's HIV / Viral Hepatitis Coinfection Program.
Taylor's research team, which included the Harvard Law School Center for Health Law and Policy Innovation, Treatment Action Group, Kirby Institute of Australia, and Brown University, found that most Medicaid coverage restrictions
for sofosbuvir violate federal Medicaid law, which requires states to cover drugs consistent with their U.S. Food and Drug Administration (FDA) labels.
Meanwhile, the Initiative for Medicines, Access & Knowledge, a non-profit group in New York, has filed a lawsuit with India's patent office seeking to prevent Gilead from receiving a patent
for sofosbuvir.
It has confirmed that 24 weeks is the optimal duration
for a sofosbuvir and ribavirin combination in GT - 3 patients, whilst also finding that sofosbuvir and ribavirin with peginterferon for 12 weeks resulted in the highest SVR12 rates observed to date in a Phase 3 study,» said Professor Tom Hemming Karlsen, Scientific Committee Member, European Association for the Study of the Liver (EASL).
Not exact matches
Thanks to a number of new Hepatitis C drugs (
Sofosbuvir Ledipasvir, Ladispavir) the disease is curable
for many patients.
This study highlights that
sofosbuvir with ribavirin and peginterferon should be considered
for interferon - eligible GT - 3 patients, particularly
for those with cirrhosis and / or prior treatment failure,» said Graham Foster, Professor of Hepatology, Queen Marys University of London, UK.
The current standard of care
for HCV genotype 3 is the nucleotide polymerase inhibitor
sofosbuvir with weight - based RBV
for 24 weeks.
Sofosbuvir can cost up to $ 55,000
for a course of treatment.
Sofosbuvir, made by Gilead Sciences in Foster City, California, debuted last December at $ 1,000 a pill — $ 84,000
for a 12 - week course.
In March, Gilead announced a deal with Egypt to provide
sofosbuvir at $ 900
for a 12 - week course.
«In distinct contrast to the situation in the U.S., Australia's Pharmaceutical Benefits Advisory Committee (PBAC) recently recommended two highly effective
sofosbuvir - based regimens
for Pharmaceutical Benefits Scheme (PBS) listing, without drug use or disease stage - related restrictions,» said co-author and professor Greg Dore of the Kirby Institute.
Taylor's team of researchers examined Medicaid policies
for hepatitis C virus treatment using
sofosbuvir, more commonly known as Solvadi, and found that most should change policy to improve access to the treatment.
«
Sofosbuvir is an extremely promising treatment
for this population.
«Given the absence to date of alternative therapies
for patients with genotype 2 or 3 who have failed interferon therapy or
for whom it is not an option, treatment with the new
sofosbuvir regimen offers a vast improvement,» Dr. Jacobson says.
301 chronically infected adults were treated with the ravidasvir /
sofosbuvir combination
for 12 weeks
for patients without cirrhosis of the liver, and
for 24 weeks
for those with compensated cirrhosis.
Results from three Phase III clinical trials (ION - 1, ION - 2 and ION - 3) evaluating the investigational once - daily fixed - dose combination of the nucleotide analogue polymerase inhibitor
sofosbuvir (SOF) 400 mg and the NS5A inhibitor ledipasvir (LDV) 90 mg, with and without ribavirin (RBV),
for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection have been presented at the International Liver CongressTM 2014.
Study results show the response rate
for all treated patients with
sofosbuvir was 78 percent compared to 0 percent in participants treated with placebo agents.
«The new
sofosbuvir therapy offers a much - needed alternative to standard therapy with interferon, which can cause significant side effects
for hepatitis C patients,» says the study's lead investigator, Dr. Ira Jacobson, chief of the Division of Gastroenterology and Hepatology and Vincent Astor Distinguished Professor of Medicine at Weill Cornell Medical College.
The recent release of drugs such as
sofosbuvir has marked the first successful and nontoxic treatments
for hepatitis C — treatments which came directly from the work of Bartenschlager, Rice, and Sofia.
This is one of the first real - life studies looking into
sofosbuvir / daclatasvir combinations and has demonstrated that this is a good therapeutic option
for these patients.
«
Sofosbuvir / daclatasvir combination effective treatment
for difficult - to - treat hep C patients.»
During
sofosbuvir's development, they had studied other drugs that inhibited different viral proteins and that might eliminate the need
for continued use of interferon and ribavirin.
In Egypt, which has the world's highest rate of hepatitis C,
sofosbuvir costs $ 300
for a 28 - day supply.
For this study, the team will test
Sofosbuvir, a new drug, and Ribavirin, which is used in the treatment with interferon.
Notably pricey members of the influential list include
sofosbuvir for HCV and the antileukemia drug Gleevec.
For example,
sofosbuvir's manufacturer, Gilead Sciences Inc. of Foster City, California, sells the drug to Egypt at a discount and allows generic manufacturers in India to produce and sell in 91 poorer countries.
Using
sofosbuvir - ledipasvir, which is sold as Harvoni, and is one several new drugs
for hepatitis C, researchers compared the costs of treating patients at all stages of fibrosis, zero through four, with the cost of waiting until stages three or four, which is when some patients are usually treated.
As part of a compassionate use program, 104 post-liver transplant patients with recurring HCV who had exhausted all treatment options and had poor clinical prognoses, received
sofosbuvir (SOF) and ribavirin (RBV) with pegylated interferon (PEG) included at the physicians» discretion
for up to 48 weeks.
Sofia will receive the 2016 Lasker - DeBakey Award on Sept. 23 along with Charles Rice, Ph.D., of Rockefeller University and Ralf Bartenschlager, Ph.D., of Heidelberg University, who were recognized
for their work in developing systems essential to hepatitis C research, which Sofia used in developing the drug,
sofosbuvir.
Sofosbuvir for Hepatitis C Genotype 2 or 3 in Patients without Treatment Options; David R. Nelson, MD, University of Florida.
The ledipasvir /
sofosbuvir combination, Harvoni ®, is now FDA - approved
for numerous types of HCV infection, including the most common form in the US and Europe.