"The FixHepC Buyers Club has successfully helped patients with a doctor's prescription to arrange personal importation and testing of a course of the drugs for a fraction of the US cost - between $US930 ($A1292) and $US1980 ($A2795). The cure rates from these generic medications have reportedly been excellent with results posted on the fixhepc.com website."
A group of campaigning patients and doctors has launched a Dallas Buyers' Club-style operation to help Australia's estimated 233,000 hepatitis C sufferers get new life-saving drugs without paying astronomical bills.
The move comes after the Kirby Institute for infection and immunity in society published a report showing the number of Australians with hep-C related severe liver disease has more than doubled in 10 years.
The FixHepC Buyers Club has been set up to import new wonder drugs such as Harvoni and Sovaldi from China, instead of waiting for Gilead Sciences, the American pharmaceutical giant which owns the patents, to negotiate a price with the Pharmaceutical Benefits Scheme.
Read more: http://www.smh.com.au/national/health/hepatitis-c-drug-buyers-club-aims-to-set-up-new-source-of-support-20150924-gjts1t.html#ixzz3mnntLHL7
Friday, September 25, 2015
One senator's push to fund hepatitis C treatment for veterans
Many veterans who fought to protect and defend our country are still fighting to get the support they need from the federal government. Fortunately, help may be on the way for veterans living with hepatitis C, one of the greatest threats facing former servicemen and women.
Recently, the Senate Appropriations Committee followed the lead of Sen. Mark Kirk (R-Ill.) and approved a budget for the Department of Veterans Affairs (VA) that included an additional $200 million to fund critical hepatitis C treatments for a total of more than $1.5 billion for hepatitis C over the next two years. The measure is now on its way to the full Senate for a final vote. This means that Kirk's pathway to securing these needed treatments for the veterans community may come in contact with federal budget cap debates and be blocked as the next federal fiscal year approaches. It will make a big difference if veterans of all generations contact their members of Congress to insist that veterans' healthcare priorities must be left untouched during spending debates. Veterans have sacrificed enough — especially those living with hepatitis C — than to have to stand by while Congress fights about the numbers.
While hepatitis C has reached epidemic levels nationwide, the veterans community has a hepatitis C infection rate that is nearly double the national average. For veterans, this deadly, blood-borne disease is a leading cause of liver failure, catastrophic liver damage and liver cancer. It impacts veterans disproportionately due to a variety of factors, including battlefield blood exposure, emergency transfusions and mandatory vaccinations in the era before hepatitis C testing became common.
Read more...
Recently, the Senate Appropriations Committee followed the lead of Sen. Mark Kirk (R-Ill.) and approved a budget for the Department of Veterans Affairs (VA) that included an additional $200 million to fund critical hepatitis C treatments for a total of more than $1.5 billion for hepatitis C over the next two years. The measure is now on its way to the full Senate for a final vote. This means that Kirk's pathway to securing these needed treatments for the veterans community may come in contact with federal budget cap debates and be blocked as the next federal fiscal year approaches. It will make a big difference if veterans of all generations contact their members of Congress to insist that veterans' healthcare priorities must be left untouched during spending debates. Veterans have sacrificed enough — especially those living with hepatitis C — than to have to stand by while Congress fights about the numbers.
While hepatitis C has reached epidemic levels nationwide, the veterans community has a hepatitis C infection rate that is nearly double the national average. For veterans, this deadly, blood-borne disease is a leading cause of liver failure, catastrophic liver damage and liver cancer. It impacts veterans disproportionately due to a variety of factors, including battlefield blood exposure, emergency transfusions and mandatory vaccinations in the era before hepatitis C testing became common.
Read more...
Monday, September 21, 2015
Gilead Drug Combo Could Be Indicated for All Forms of Hepatitis C
Study shows drug may eliminate need for HCV genotype testing altogether
A new Gilead Sciences drug combination that targets six genotypes of the hepatitis C virus (HCV) has achieved promising results in four international phase III clinical studies.
Gilead has announced results from ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. The studies evaluated a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) with velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of genotype 1 to 6 chronic HCV infection.
In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1 to 6 HCV infection received 12 weeks of SOF/VEL. Among these patients, 21%% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was a sustained virological response at week 12 post-treatment (SVR12)
Read more.....
A new Gilead Sciences drug combination that targets six genotypes of the hepatitis C virus (HCV) has achieved promising results in four international phase III clinical studies.
Gilead has announced results from ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4. The studies evaluated a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF) with velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of genotype 1 to 6 chronic HCV infection.
In the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 1,035 patients with genotype 1 to 6 HCV infection received 12 weeks of SOF/VEL. Among these patients, 21%% had compensated cirrhosis and 28% had failed prior treatments. The ASTRAL-4 study randomized 267 patients with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL. The primary endpoint for all studies was a sustained virological response at week 12 post-treatment (SVR12)
Read more.....
U.S. Food and Drug Administration Grants Fast Track Designation to Can-Fite's CF102 in the Treatment of Liver Cancer
PETACH TIKVA, Israel, Sept. 17, 2015 /PRNewswire/ -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, today announced the U.S. Food and Drug Administration (FDA) has granted the Company's drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA's Orphan Drug designation.
Can-Fite is currently conducting a Phase II study for this indication in the U.S., Europe and Israel. The randomized, double blind, placebo controlled study is expected to complete enrollment by the end of the first half of 2016 in 78 patients with Child-Pugh Class B cirrhosis who failed the only FDA approved drug on the market, Nexavar® (sorafenib). Patients are treated twice daily with 25 mg of oral CF102, which has been found to be the most efficacious dose in Can-Fite's earlier Phase I/II study resulting in the longest overall survival time, with excellent safety results.
Fast Track, aimed at getting important new drugs that meet an unmet need to patients earlier, is expected to expedite the development of CF102. Drugs that receive Fast Track designation benefit from more frequent meetings and communications with the FDA to review the drug's development plan to support approval. It also allows the Company to submit parts of the New Drug Application (NDA) on a rolling basis for review as data becomes available. Since the Fast Track Program started, from March 1998 through June 30, 2015 a total of 318 Fast Track applications have been received by the FDA. The FDA has granted 202 of them, and denied 110, with 6 more pending.
"We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients."
According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015. Nexavar® annual sales, as reported by Bayer, were €773 million in 2014.
About CF102
CF102 is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in tumor cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells.
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company is preparing for a Phase III CF101 trial for rheumatoid arthritis and is preparing its protocol for its next advanced psoriasis clinical trial. Can-Fite's liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company's CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Friday, September 18, 2015
Researchers find HCV treatment uptake declined over time among HIV/HCV coinfection
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In the Swiss HIV Cohort Study, researchers found that hepatitis C virus infection treatment uptake over the last 13 years has been low and many patients co-infected with HIV and hepatitis C remained untreated since 2013.
“The Swiss HIV Cohort Study offers an ideal platform to study the natural course of HCV infection and long-term influence of HCV treatments in a nationwide representative population of HIV-infected patients,” the researchers wrote in the Journal of Hepatology. “We aimed to assess the changes in epidemiology, clinical course and therapy of HCV infection between 2001 and 2013 and to characterize the population who remains eligible for the new HCV treatment options by the end of 2013.”
Of 12,401 patients, 17% were positive for HCV RNA (n = 2,107) and 23.8% were seropositive for HCV. Thirty-percent of the HCV RNA-positive patients (n = 636) began therapy with an incidence of 5.8 per 100 person-years (95% CI, 5.3-6.2). Of the patients treated with pegylated interferon and ribavirin, 50% achieved sustained virologic response, which represented 15% of all participants with replicating HCV infection, according to the research. Also, of the 636 treated patients, 11% were treated twice and 2% were treated at least 3 times.
Hepatitis C Workshop Set
ALAMOSA — Hepatitis C is an infectious (contagious) liver disease that spreads through blood-to-blood contact with an infected person.
Andres Guerrero with the Colorado Department of Public Health and Environment and Chris Grano with Hep C Connection in Denver will present the workshop ”Hep C- What you need to Know” on Thursday, October 8, in Alamosa.
The workshop will be held at SLV Heath Education Center at 1919 Main St. in Alamosa. Two times for the same program are available — 3:30–5 p.m. and 7– 8:30 p.m.
Hep C testing will be available at no charge for people who use injection drugs, were born between 1945 and 1965, had sex partners who are Hep C positive, had tattoos in prison or jail and/or had blood products or tissue before 1992. Testing is available for those who qualify with the above criteria through the Colorado Department of Public Health and Environment from 1– 2:30 p.m. October 8th at the SLV Heath Education Center at 1919 Main St. in Alamosa. No appointment is needed for testing and spaces are limited.
Call the SLV AHEC at 589-4977 for further information or to register by October 6.
Read more....
Andres Guerrero with the Colorado Department of Public Health and Environment and Chris Grano with Hep C Connection in Denver will present the workshop ”Hep C- What you need to Know” on Thursday, October 8, in Alamosa.
The workshop will be held at SLV Heath Education Center at 1919 Main St. in Alamosa. Two times for the same program are available — 3:30–5 p.m. and 7– 8:30 p.m.
Hep C testing will be available at no charge for people who use injection drugs, were born between 1945 and 1965, had sex partners who are Hep C positive, had tattoos in prison or jail and/or had blood products or tissue before 1992. Testing is available for those who qualify with the above criteria through the Colorado Department of Public Health and Environment from 1– 2:30 p.m. October 8th at the SLV Heath Education Center at 1919 Main St. in Alamosa. No appointment is needed for testing and spaces are limited.
Call the SLV AHEC at 589-4977 for further information or to register by October 6.
Read more....
Thursday, September 17, 2015
Managing Hepatitis C: Advances in treatment & evaluation
Improvements to the efficacy and side effects of hepatitis C medications have simplified the disease management calculus, tipping the scales towards treatment.
The availability of effective oral medication has also raised the bar for clinicians: is there a way to make similar progress in the evaluation side? What would it take to stage the disease quickly, safely, and without discomfort for the patient?
The stiffness of the patient's liver tissue, categorized at a certain stiffness as "fibrosis," provides hepatologists important diagnostic information about the extent and stage of hepatitis C. Liver biopsy has long been the gold standard for obtaining this information. However, biopsies are time-consuming invasive procedures that routinely cause patients pain and, in some rare instances, lead to greater complications such as internal bleeding. These procedures take up clinical staff time, necessitate bed space, and incur instrument and room sterilization costs. Lastly, they are subject to not insignificant sampling limitations, as each biopsy takes only a small sample from a large organ.
Read more...
The availability of effective oral medication has also raised the bar for clinicians: is there a way to make similar progress in the evaluation side? What would it take to stage the disease quickly, safely, and without discomfort for the patient?
The stiffness of the patient's liver tissue, categorized at a certain stiffness as "fibrosis," provides hepatologists important diagnostic information about the extent and stage of hepatitis C. Liver biopsy has long been the gold standard for obtaining this information. However, biopsies are time-consuming invasive procedures that routinely cause patients pain and, in some rare instances, lead to greater complications such as internal bleeding. These procedures take up clinical staff time, necessitate bed space, and incur instrument and room sterilization costs. Lastly, they are subject to not insignificant sampling limitations, as each biopsy takes only a small sample from a large organ.
Read more...
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