MINOT, N.D. — Victims of the third largest hepatitis C outbreak in U.S. history who contracted the disease at a Minot nursing home are asking a federal court to certify their lawsuit as a class-action case.
The state Health Department has said there have been 51 cases of hepatitis C linked to the outbreak in Minot. At least 47 of the reported cases have been identified in former or current residents.
An investigation by Health Department concluded the outbreak may have been associated with phlebotomy or podiatry and nail care services provided at the ManorCare facility.
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Saturday, January 17, 2015
Gilead to appeal India patent ruling on hepatitis C drug
(Reuters) - U.S.-based Gilead Sciences Inc will appeal the Indian patent office's rejection of its application for hepatitis C drug Sovaldi, a move that could allow local drugmakers to launch cheaper generic versions of the $1,000-a-pill medicine.
The rejection relates to the patent application covering the metabolites, or small molecules, of sofosbuvir, the chemical name of Sovaldi.
Indian drugmaker Natco Pharma and the Initiative for Medicines, Access & Knowledge (I-MAK) had opposed Gilead's application on the grounds that the drug is not inventive enough compared with a previous formulation.
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Vertical Transmission of HCV: The Next Big Treatment Frontier
Novel antiviral therapies with overwhelmingly positive sustained virologic response rates have dominated headlines in hepatitis C virus for the past few years, but many experts said eradication efforts may never completely succeed until the clinical community deals with vertical transmission of the disease.
There may be as many as 11 million children with HCV in the world, according to Kathleen B. Schwarz, MD, professor of pediatrics, director of the Pediatric Liver Center at Johns Hopkins and president of the Federation of International Societies of Pediatric Gastroenterology, Hepatology, and Nutrition.
Philip Rosenthal, MD, professor of pediatrics and surgery, director of pediatric clinical research, pediatric hepatology and liver transplant research and pediatric hepatology at the University of California, San Francisco, pushed that number higher, suggesting that as many as 7,500 new cases occur from vertical transmission each year in the United States. “Spontaneous clearance of the virus can be seen in up to 40% of infants infected by vertical transmission, but only in 6% to 12% of older children with HCV,” he told HCV Next. “A small subset of children — between 20% and 25% — can have more aggressive disease with evidence of cirrhosis or hepatocellular carcinoma.”
Read complete article here...
There may be as many as 11 million children with HCV in the world, according to Kathleen B. Schwarz, MD, professor of pediatrics, director of the Pediatric Liver Center at Johns Hopkins and president of the Federation of International Societies of Pediatric Gastroenterology, Hepatology, and Nutrition.
Philip Rosenthal, MD, professor of pediatrics and surgery, director of pediatric clinical research, pediatric hepatology and liver transplant research and pediatric hepatology at the University of California, San Francisco, pushed that number higher, suggesting that as many as 7,500 new cases occur from vertical transmission each year in the United States. “Spontaneous clearance of the virus can be seen in up to 40% of infants infected by vertical transmission, but only in 6% to 12% of older children with HCV,” he told HCV Next. “A small subset of children — between 20% and 25% — can have more aggressive disease with evidence of cirrhosis or hepatocellular carcinoma.”
Read complete article here...
Aetna backs Gilead's hepatitis C treatment, gets discount
(Reuters) - Aetna Inc, the third-largest U.S. health insurer, said it negotiated a discount with Gilead Sciences Inc for its hepatitis C treatment and will offer it as the preferred choice to nearly 11 million commercial customers.
Aetna, which posted an updated coverage policy on its website on Friday, said it believes the price it received for Gilead's Sovaldi, and a newer combination treatment called Harvoni, is "competitive with other recently announced agreements for this class of therapy." It would not detail the size of the discount.
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Aetna, which posted an updated coverage policy on its website on Friday, said it believes the price it received for Gilead's Sovaldi, and a newer combination treatment called Harvoni, is "competitive with other recently announced agreements for this class of therapy." It would not detail the size of the discount.
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Friday, January 16, 2015
At The Crossroads: The Road Ahead For Hep C
Our months-long series about hepatitis C, "At the Crossroads: The Rise of Hepatitis C and the Fight to Stop It," has officially come to an end. We had a great public forum ("Hepatitis C: Cost, Cure, and Challenge") last night at Brown University, some key takeaways from which I'll share, below.
The stories continue
But first: the series may be over, but the stories of patients living with this chronic disease, the stories of people in the depths of addiction, putting themselves at risk of catching hepatitis C any time they share a needle or drug paraphernalia, the stories of doctors and nurses and public health workers and researchers on the front lines and in the trenches, fighting this disease, all those stories continue. And I'll keep you posted.
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The stories continue
But first: the series may be over, but the stories of patients living with this chronic disease, the stories of people in the depths of addiction, putting themselves at risk of catching hepatitis C any time they share a needle or drug paraphernalia, the stories of doctors and nurses and public health workers and researchers on the front lines and in the trenches, fighting this disease, all those stories continue. And I'll keep you posted.
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UK: Janssen will cover cost of unsuccessful hepatitis C treatment
NHS England will only have to pay for Olysio if patient clears virus
The innovative 'pay if you clear' scheme marks a new way of dealing with the struggle for market access in the UK for pharma companies, with Janssen offsetting the cost of the drug if a patient remains infected after 12 weeks of treatment.
Olysio (simeprevir) is one of several new oral drugs that mark a major step forward in hepatitis C treatment, alongside Gilead Science's Sovaldi (sofosbuvir) and AbbVie's regimen combining Viekirax (ombitasvir/paritaprevir/ritonavir) and Exviera (dasabuvir).
Both Olysio and Sovaldi were this week recommended for NHS reimbursement in draft guidance published by the National Institute for Health and Care Excellence (NICE).
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More UK patients will now be eligible for two costly hepatitis C treatments
Sofosbuvir has received the green light from NICE but will not be available to patients until August 2015, while simeprevir will only be accessible through a patient access scheme.
Expensive treatments for hepatitis C will now be available to more patients in the UK, according to final draft guidance from the National Institute for Health and Care Excellence (NICE) published on 16 January 2015.
NICE has extended its original draft recommendations for simeprevir and sofosbuvir to cover more people with hepatitis C. However, patients will have to wait until August 2015 for sofosbuvir, and simeprevir will be available only under a groundbreaking ‘pay if you clear’ deal agreed with the manufacturer.
NICE has issued final draft guidance[1] recommending simeprevir (Olysio, Janssen), in combination with peginterferon alfa and ribavirin, as an option for treating two forms of hepatitis – genotype 1 and genotype 4 (4% of diagnoses). The previous draft guidance did not recommend simeprevir for treating genotype 4.
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