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Alan Franciscus
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated January 12, 2015

Saturday, January 31, 2015

Delhi HC sets aside order on Gilead’s Sovaldi patent

New Delhi: In a setback to generic drug makers, the Delhi high court on Friday set aside an order of the Deputy Controller of Patents and Designs rejecting a patent to US drug maker Gilead Pharmasset Llc for the hepatitis C drug Sovaldi.

The medicine costs $1,000 a pill and cures hepatitis C in 90% of cases when given for a 12-week course. India’s patent office had questioned the therapeutic efficacy under which the patent was claimed by Gilead and rejected its application using the controversial Section 3(d) of the Patents Act, which prevents evergreening of patents and provides that no new form of an existing substance shall be patented unless the new form is much more effective than the old one.

The Indian patent office, while rejecting the patent application, had maintained that minor changes in the molecule did not improve its efficacy. With the patent set aside, domestic generic drug manufacturers could make the same drug for as low as $1 a pill. “It was expected that the appeal would succeed because the process of reasoning in the controller’s order was really shoddy, without commenting on the merits of the conclusion,” said Shamnad Basheer, former professor at National University of Juridical Sciences, Kolkata, and founder of intellectual property blog SpicyIP.

Read more at: http://www.livemint.com/Politics/1l6EyoCRGd45A6oT0qpsBO/Delhi-high-court-sets-aside-order-on-Gileads-Sovaldi-patent.html?utm_source=copy

Friday, January 30, 2015

"At the Crossroads: The Rise of Hepatitis C and the Fight to Stop It"

Hepatitis C infects an estimated five million Americans, though most of them don’t know it. But deaths from hepatitis C are on the rise in baby boomers.

And throughout New England, new infections are creeping up among a younger generation.

Less than a year ago, their only options for treatment were complicated regimens of injections that didn’t always lead to a cure. But brand new drugs could change everything. That is, if the cost doesn’t break us.


AbbVie Announces Top-line Results from Phase 3 Study of All-Oral Treatment for Hepatitis C in Japan

Jan 30, 2015

- 95 percent SVR12 rate achieved in Japanese patients new to therapy with genotype 1b chronic hepatitis C virus infection without cirrhosis and with a high viral load
- Regulatory filing in Japan planned for the first quarter of 2015

NORTH CHICAGO, Ill., Jan. 30, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) released top-line Phase 3 results for its investigational, all-oral, ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan. The primary endpoint of the GIFT-I study was achieved, demonstrating 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 GT1b Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load.

"AbbVie is committed to advancing HCV care with the goal of evaluating our treatment in a broad range of patients around the world," said Scott Brun, M.D., vice president, pharmaceutical development, AbbVie. "The GIFT-I results are encouraging and support moving forward with our Japan development program, with a local regulatory submission anticipated in the first quarter of 2015."

In Japan, up to two million people are currently living with hepatitis C.1 Genotype 1b is the most common sub-genotype, affecting nearly half of the people infected with HCV.2

In the GIFT-I study, the primary efficacy population comprised a sub-group of treatment-naive GT1b chronic HCV infected patient population. This sub-group consisted of treatment-naive patients without cirrhosis who were eligible for therapy with IFN with or without RBV, had a high viral load (> 100,000 IU/mL) and received at least one dose of the double-blind active study drug. The primary endpoint was assessed at 12 weeks post treatment (SVR12).

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). Two patients without cirrhosis (0.9 percent) discontinued treatment due to adverse events.
Within the primary efficacy patient population, there were no on-treatment virologic failures and 2.8 percent of patients (n=3/109) experienced relapse.

AbbVie will disclose detailed GIFT-I study results at future scientific congresses and in publications.

About 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-naive) 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.

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 1b chronic hepatitis C virus (HCV) infection in Japan, AbbVie's investigational two direct-acting antiviral treatment consists of the fixed-dosed 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 will focus on our investigational, two direct-acting antiviral treatment and is designed with the goal of achieving high sustained virologic response 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.

About AbbVieAbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs more than 26,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking StatementsSome statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Kohnodai Hospital. National Center for Global Health and Medicine [cited 20 February 2013]. Available from: http://www.ncgm.go.jp/center/forpatient_hcv.html
2 Hajarizadeh B et al. Nat Rev Gastroenterol Hepatol 2013; 10: 553-562. http://www.nature.com/nrgastro/journal/v10/n9/fig_tab/nrgastro.2013.107_F1.html. Accessed December 2014


For further information: Media: Judy Low, +65 9880 2604, judy.low@abbvie.com; Jackie Finley, +1 (847) 937-3998, jaquelin.finley@abbvie.com; Investor Relations: Liz Shea, +1 (847) 935-2211, liz.shea@abbvie.com

Local Hepatitis C cases hit all-time high

A dangerous viral infection saw a dramatic spike in cases in Ross County during 2014, according to year-end numbers from the Ross County Health District.

Hepatitis C cases in the county jumped from 153 in 2013 to 234 last year – an increase of 53 percent and an all-time high locally.

“This is easily the highest number of cases ever reported to us,” said Kathy Wakefield, director of Public Health Nursing at the Ross County Health District. “It’s very concerning, especially considering how big of an increase it was in just one year.”


Hot on the trail of the hepatitis-liver cancer connection

Using whole genomic sequencing, scientists from RIKEN in Japan have for the first time demonstrated the profound effect that chronic hepatitis infection and inflammation can have on the genetic mutations found in tumors of the liver, potentially paving the way to a better understanding of the mechanisms through which these chronic infections can lead to cancer. Primary liver cancer is the third leading cause of cancer death worldwide, and recent studies have shown that particularly in Asia, infection with either hepatitis B or C is often associated with such cancers.

For the study, which was published in Nature Communications, the group performed whole genomic sequencing on 30 individual tumors classified as liver cancer displaying a biliary phenotype. This type of cancer originates in the liver, but is different from hepatocellular carcinoma, the dominant form of primary liver cancer, and is generally more aggressive, with poorer prognosis. They compared the data with 60 of the more-common hepatocellular carcinoma tumors. To study gene expression, they then examined RNA sequencing data from 25 of the biliary-phenotype cancers and 44 hepatocellular cancers.


Thursday, January 29, 2015

Expensive Hepatitis C Cure ─ Georgia Decides Who Gets It, Who Doesn't

There’s a new drug on the market that’s up to 99 percent effective at curing hepatitis C, an often deadly liver virus. The drug is known as “V-pak.”

Some Georgians will get it.

But thousands of HIV-positive Georgians, who also have hepatitis C, won't.

The reason? Cost.

Read more and listen to the podcast here....

Harvard Pilgrim negotiates discount on pricey hepatitis drug

Harvard Pilgrim Health Care has become the first regional health insurer to negotiate a discount on a costly new hepatitis C drug regimen that cures more than 90 percent of people with the virus but inflicts steep financial losses on payers.

Under a one-year contract with Gilead Sciences Inc., maker of the two-drug Harvoni treatment for the liver-ravaging disease, Wellesley-based Harvard Pilgrim expects to save about $10 million on reimbursements to doctors who treat hepatitis C patients. The insurer didn’t disclose how much it will pay for the drug after a rebate from Gilead.

Harvard Pilgrim followed the lead of national pharmacy benefit managers such as CVS/Caremark and Express Scripts, which buy prescription drugs in bulk. Taking advantage of a rival hepatitis C drug combination from AbbVie Inc., those companies recently bargained with both drug makers to secure rebates.

Read more....