«The discovery
of sofosbuvir was a team effort, and I am honored and humbled to be receiving this recognition,» Sofia said.
In subsequent tests using an immunodeficient mouse model infected by Zika, intravenous injections
of sofosbuvir significantly reduced viral loads in blood serum compared to a placebo group.
Since then, Gilead has run three additional studies
of sofosbuvir paired with a different drug, ledipasvir.
In a more advanced trial, 12 weeks
of sofosbuvir plus ribavirin yielded the same results as 24 weeks of interferon plus ribavirin: 67 percent of patients had no evidence of the virus in their blood (although side effects such as fever and depression were fewer among patients who did not receive interferon).
Another paper in the same edition of the NEJM reports two additional studies
of sofosbuvir - containing therapy, one evaluating a 12 week regimen of peginterferon, ribavirin and sofosbuvir in patients with genotypes 1, 4, 5 and 6 who have never been treated before; the other reporting results of a trial comparing 24 weeks of peginterferon and ribavin with 12 weeks
of sofosbuvir and ribavirin in treatment naïve patients with genotypes 2 and 3.
«The results of the ION studies demonstrated highly satisfactory cure rates with a fixed dose combination
of sofosbuvir / ledipasvir among patients with genotype 1 HCV infection without the use of either injectable interferon, which causes miserable flu - like symptoms, or ribavirin, an antiviral pill associated with a variety of troublesome side effects, including anemia and rash,» Professor Peck - Radosavljevic continued.
Results presented today at The International Liver Congress ™ 2015 demonstrate that hepatitis C (HCV)- infected genotype - 3 (GT - 3) patients, with and without cirrhosis, receiving 24 weeks
of sofosbuvir (SOF) in combination with ribavirin (RBV) and peginterferon (PEG) achieved the highest sustained virologic response rates at 12 weeks (SVR12), observed in a Phase 3 study, to date.
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.
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).
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.
The most common restrictions fall into three categories: 1) The level
of fibrosis (i.e., scarring
of the liver); 2) substance use and abstinence from alcohol / drug use together with toxicology screening; and 3) provider limitations, which limit the physicians allowed to prescribe
sofosbuvir.
«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 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.
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.
In September 2017, the government
of Malaysia issued a «government - use» license on
sofosbuvir patents to allow 400,000 people living with hepatitis C in Malaysia to access generic HCV regimens in public hospitals.
«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.
The drug
sofosbuvir works by interfering with the ability
of the hepatitis C virus to replicate.
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.
«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.
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.
«Ledipasvir plus
sofosbuvir: Hint
of added benefit in further patient group.»
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.
«The cohort study has found that the
sofosbuvir / daclatasvir combination is associated with a high rate
of SVR4 in difficult - to - treat patients infected by genotype - 1 hepatitis C.
Six months prior, the U.S. Food & Drug Administration (FDA) approved
sofosbuvir, an oral medication shown to cure most cases
of hepatitis C infection, with fewer side effects than the current treatment options.
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.
A study presented today that evaluated an investigational dosage
of once - daily ledipasvir 45 mg /
sofosbuvir 200 mg (LDV / SOF) in children aged six to 11 years infected with the Hepatitis C virus (HCV), found that 99 %
of children (n = 89/90) had undetectable levels
of HCV - RNA 12 weeks after treatment.
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.
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.
Moreover, fetuses
of Zika - infected pregnant mice did not show detectable Zika virus amplification in the
sofosbuvir - treated group.
The drug works by inhibiting replication
of the hepatitis C virus; researchers noted that both hepatitis C and Zika belong to the same viral family and bore strong structural similarities that could make
sofosbuvir effective against the latter.
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.
The higher cure rate and lessened side - effects
of treating patients with an all - oral combination
of ledipasvir and
sofosbuvir (LDV / SOF) results in greatly reduced absenteeism and improved workplace productivity that can translate into enormous benefit, according to the new economic model used by researchers at Inova Fairfax Medical Campus, VA..
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.
Today, with just 12 weeks
of treatment with drug combinations that use Sofia's drug,
sofosbuvir (Sovaldi ®) as the backbone
of Harvoni ®, almost all those treated are cured.
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.
The drugs — Olysio (simeprevir) and Solvadi (
sofosbuvir)-- cure up to 80 %
of cases.
Examples
of DAAs, which come in pill form, are Olysio (simeprevir); Sovaldi (
sofosbuvir), which is used in combination with Olysio; Daklinza (daclatasvir); and Harvoni (a combination
of ledipasvir and
sofosbuvir).