Study: Door-to-door campaign linked hepatitis C patients to care

Effort overcame the many hurdles to specialized treatment for Philadelphia's medically underserved

PROVIDENCE, R.I. [Brown University] -- In Philadelphia, as in many cities, neighborhoods with high rates of hepatitis C virus (HCV) often also have limited access to screening and treatment. A new study in the Journal of General Internal Medicine shows that when expert advocates made a focused effort in a medically underserved area, they were able to help vulnerable patients leap each of the many hurdles that often keep people out of care.

"This study demonstrates the importance of community-based testing for HCV in identifying previously undiagnosed individuals and re-engaging those aware of their diagnosis but not currently in care," Trooskin said. "We learned that a comprehensive approach to nonclinical testing is critical and must integrate immediate access to confirmatory testing as well as intensive patient navigation to effectively link patients to care. Although hepatitis C is now a curable disease, we identified new barriers to care such as the need for a referral to subspecialty care and challenges obtaining medication approval for patients, particularly those covered under Medicaid."

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PCORI Announces $50 million in Hepatitis C Research Funding

Hepatitis C virus (HCV) research recently received a significant boost with a commitment of up to $50 million in funding from the Patient-Centered Outcomes Research Institute (PCORI) for comparative clinical effectiveness research (CER) studies on the best ways to diagnose and treat HCV infection.  PCORI posted application materials earlier this month and announced a May 5, 2015 application deadline.

“HCV is a major health threat that can have devastating consequences for infected people and their families,” said PCORI Executive Director Joe Selby, MD, MPH, in a press release announcing the funding commitment. “Recently approved medications are immensely promising and offer vast improvements over previous therapies, but as yet there’s no ‘real-world’ evidence of their long-term effectiveness nor comparative evidence to help inform decisions about screening, diagnosis, and treatment of HCV.”

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Gilead agrees 41,000 euro hep-C drug price for 12 week treatment

(Reuters) - Drugmaker Gilead has agreed on a price for its hepatitis C drug Sovaldi of 41,000 euros ($46,625) for a 12-week treatment for Germany's statutory medical insurers, the GKV association of Germany's statutory medical insurers said.

GKV, who provides coverage for about nine out of 10 Germans, said the U.S. biotechnology company had agreed on a price of 43,562.52 euros, which is subject to a 5.88 percent discount for statutory insurers.

The drug had initially been offered in Germany for a list price of 60,000 euros, or about 56,500 euros including the discount.

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Idaho DOC requests $800K to treat inmates with Hepatitis C

Cost difference between treating the inmates and letting them die in the ICU is "a compelling argument" for taxpayers 

BOISE, Idaho — The Department of Corrections has requested $800,000 to purchase a cure for hepatitis C that would run $94,000 a patient in order to treat infected inmates.

Related Articles: Cost for Hepatitis C drugs for prisoners risingHepatitis C treatment costs $90,000 per R.I. inmate

The Idaho Statesman reports that the cost difference between treating the inmates and letting them die in the ICU is “a compelling argument” for taxpayers.

The treatment for one patient who died of liver failure brought on by the disease added to up to $200,000.

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Canada: $5M Hepatitis C strategy announced by P.E.I. government

P.E.I. is first province to offer newly-approved treatments with cure rates of 95% to 100% 

A new $5-million hepatitis C management strategy unique to P.E.I. was announced by the province's Health and Wellness Minister Thursday morning.

Health Canada recently approved new treatments that can cure the HCV Hepatitis C genotype 1, which is carried by 70 to 75 per cent of Islanders with the contagious liver disease.

It is also the most difficult genotype to treat.

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AbbVie Submits New Drug Application in Japan for its Investigational, All-Oral, Treatment for Chronic Hepatitis C

- Submission based on Phase 3 GIFT-I study in patients with genotype 1b chronic hepatitis C virus infection

- GIFT-I met its primary endpoint, achieving 95 percent sustained virologic response rate at 12 weeks post-treatment; two patients (0.9 percent) discontinued treatment due to adverse events

- AbbVie's treatment for Japanese hepatitis C patients consists of a 12-week, two direct-acting antiviral, fixed-dose combination of paritaprevir/ritonavir with ombitasvir, dosed once daily

NORTH CHICAGO, Ill., Feb. 11, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the company's investigational, all-oral, ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily. The submission is for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

The NDA is supported by the Phase 3 GIFT-I study, which met its primary endpoint, achieving a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post-treatment (SVR₁₂) in the sub-group of previously untreated, non-cirrhotic, adult genotype 1b (GT1b)-infected Japanese patients who were eligible for therapy with IFN and had a high viral load (≥ 100,000 IU/mL). Additionally, two patients without cirrhosis (0.9 percent) discontinued treatment due to adverse events. GIFT-I included a placebo-controlled arm and studied patients with and without compensated cirrhosis, who were new to therapy or treatment-experienced (with IFN and with or without RBV).

"We are pleased to announce the regulatory submission of our two direct-acting hepatitis C antiviral treatment in Japan, which follows on quickly from recent approvals of our three direct-acting antiviral treatment in the U.S., Canada and the European Union," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "This submission is based on a large Phase 3 study in multiple patient types and brings us closer to offering the possibility of cure for patients with chronic genotype 1b hepatitis C infection, the most common form of the disease in the country."

AbbVie studied a two direct-acting antiviral regimen without RBV in Japan due to patient and viral characteristics specific to the Japanese population, including high prevalence of GT1b. In Japan, approximately 1.5 to 2 million people are living with HCV.¹ Genotype 1 is the most common HCV genotype in Japan with 60 to 70 percent of patients infected and, of those, about 95 percent are infected with the GT1b sub-type.²

About the GIFT-I Study GIFT-I (M13-004) is a Phase 3, multi-center study designed to evaluate the efficacy and safety of 12 weeks of treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in adult Japanese patients (n=363) with chronic genotype 1b hepatitis C virus infection. Patients included those without cirrhosis and with compensated cirrhosis, who were new to therapy (treatment-naïve) or had failed previous treatment with interferon with or without ribavirin (treatment-experienced).

The study consists of two sub-studies. Sub-study one included patients without cirrhosis randomized to OBV/PTV/r or placebo. Sub-study two included patients with compensated cirrhosis, who received open-label treatment with OBV/PTV/r.

Within the primary efficacy patient population, there were no on-treatment virologic failures and 2.8 percent of patients (n=3/109) experienced relapse.

In patients without cirrhosis, the most commonly reported adverse events in the treatment arm were nasopharyngitis (16.7 percent OBV/PTV/r vs. 13.2 percent placebo), headache (8.8 percent OBV/PTV/r vs. 9.4 percent placebo), and oedema peripheral (5.1 percent OBV/PTV/r vs. 0 percent placebo).

Additional information about AbbVie's GIFT-I study can be found on www.clinicaltrials.gov.

About AbbVie's Investigational Two Direct-Acting Antiviral HCV TreatmentFor the treatment of genotype 1 chronic hepatitis C virus (HCV) infection in Japan, AbbVie's investigational two direct-acting antiviral treatment consists of the fixed-dose combination of paritaprevir/ritonavir (150/100 mg) with ombitasvir (25 mg), dosed once daily.

AbbVie's chronic HCV treatment combines two direct-acting antivirals, each with a distinct mechanism of action that targets and inhibits specific HCV proteins of the viral replication process.

About AbbVie's HCV Clinical Development Program in Japan AbbVie's HCV clinical development program in Japan focuses on its investigational, two direct-acting antiviral treatment and is designed with the goal of achieving high SVR rates in chronic HCV infected patients, including additional genotypes and patients with compensated cirrhosis.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

Ombitasvir/paritaprevir/ritonavir is an investigational product and its safety and efficacy have not been established in Japan.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbvie-submits-new-drug-application-in-japan-for-its-investigational-all-oral-treatment-for-chronic-hepatitis-c-300035051.html

SOURCE AbbVie

India: Cipla to name Gilead hepatitis C generic Hepcvir

Pharma major Cipla plans to name its hepatitis C drug with Gilead Sciences as Hepcvir, its chairman Yusuf K Hamied on Wednesday. Last year Gilead Sciences has licensed its hepatitis C drug Sovaldi (chemically known as sofosbuvir) to seven India-based drugmakers including Cipla which will sell the cheap generic versions of the drug in 91 developing nations. Hepcvir is the brand name and we are working on it. We will apply probably for regulatory approval in the next couple of months and hopefully by middle of the year we will be in market for India. We have the stocks of the raw materials, we are already started making the raw materials. We have to put the stability data of active pharmaceutical ingredients, stability data of the formulation, we have to do bioequivalence of the originator product, so these takes around six months and this is already in process," he said.

The Mumbai-based drug maker has signed a non-exclusive licensing agreement with Gilead for manufacturing and distribution of Sofosbuvir mono, Ledipasvir mono, the fixed-dose combination of Ledipasvir/Sofosbuvir with each other and the combination of Sofosbuvir or Ledipasvir with other active substances, for the treatment of hepatitis C.

All companies have been allowed to set their own prices for the generic drug and will pay Gilead a royalty on their sales.

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