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Alan Franciscus
Editor-in-Chief
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated March 17, 2015

Friday, March 27, 2015

India: Strides Arcolab Launches Generic Version of Hepatitis C Drug

New Delhi: Strides Arcolab on announced launch of the generic version of Hepatitis C drug 'Sofosbuvir' under the brand name 'Virso'.

The product will be available to Indian patients shortly, the Bangalore-based company said in a statement.

"In September 2014, Strides entered into a licensing agreement with Gilead Sciences Inc to bring Hepatitis C cure to 91 developing countries," Strides Arcolab said in a statement.

Read more...

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Sovaldi® (sofosbuvir) for the Treatment of Genotype 2 Chronic Hepatitis C

-- Sovaldi Part of First All-Oral Treatment Regimen for Genotype 2 Patients in Japan --
-- 96 Percent Cure Rates and Shortened, 12-Week Course of Therapy --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 26, 2015-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Sovaldi® (sofosbuvir), a once-daily nucleotide analog polymerase inhibitor, for the suppression of viremia in patients with genotype 2 chronic hepatitis C virus (HCV) infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection. Sovaldi is also the first product to be marketed by Gilead in Japan.

“Today’s approval represents an important step forward in the management of hepatitis C in Japan, enabling genotype 2 infected patients the opportunity of a cure in 12 weeks with an all-oral regimen that eliminates the need for interferon,” said Masao Omata, MD, Yamanashi Prefectural Hospital Organization.

Primarily due to HCV, Japan has one of the highest rates of liver cancer of any industrialized country. Of the more than one million people chronically infected with HCV, 20-30 percent have the genotype 2 strain of the virus. Currently approved therapies in Japan for genotype 2 HCV infection involve 24-48 weeks of injections with pegylated interferon, which may not be suitable for many patients.

Sovaldi’s approval is supported by data from a Phase 3 clinical trial conducted in Japan (Study GS-US-334-0118) among treatment-na├»ve and treatment-experienced genotype 2 patients. Approval was based on 96 percent (n=135/140) of genotype 2 HCV-infected patients who received 12 weeks of an all-oral regimen of Sovaldi plus RBV 600–1,000 mg/day achieving a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection. The approval is also supported by SVR12 results from four international Phase 3 studies (FISSION, FUSION, POSITRON and VALENCE), which included genotype 2 HCV patients.

“There is a need in Japan for new HCV treatment options that are more effective and better tolerated and we have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety of Sovaldi,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to making Sovaldi available in Japan as quickly as possible, while simultaneously continuing to work with the agency on its review of our second application for an all-oral sofosbuvir-based regimen for the treatment of genotype 1 HCV infection.”

Gilead filed a New Drug Application (NDA) in Japan for a single-tablet regimen of sofosbuvir and the NS5A inhibitor ledipasvir for the treatment of genotype 1 HCV infected patients on September 24, 2014. The ledipasvir/sofosbuvir single tablet regimen is an investigational product in Japan and its safety and efficacy have not yet been established.

- See more at: http://gilead.com/news/press-releases/2015/3/japans-ministry-of-health-labour-and-welfare-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-genotype-2-chronic-hepatitis-c#sthash.tfSV7EEB.dpuf

Wednesday, March 25, 2015

Kentucky to Allow Local Needle Exchanges

In a last-minute compromise, Kentucky lawmakers took a strong, collective step toward combating the heroin epidemic that kills hundreds each year and puts countless others in danger.  The Kentucky House of Representatives voted 100-0 in favor of Senate Bill 216, while the Senate voted 34-4 in favor.

The most debated part of the bill was approval of local needle exchanges, which would be funded through tax dollars. Opponents in the Senate, who voted after the House unanimously approved the bill, said needle exchanges would further enable heroin users and make the overall problem worse. Supporters said needle exchanges will keep used needles out of public areas, and lessen the risk of infection to those who do not use drugs. They also pointed to studies that claim needle exchanges curb the spread of diseases like Hepatitis C and AIDS.

SB 216 also calls for tougher punishment for convicted large-scale traffickers. They are dealers carrying at least 60 grams of heroin. They would have to serve at least half their sentences before any possibility of parole.



The end of hepatitis C?

2014 will do down as a pivotal year in the fight against hepatitis C virus (HCV), a blood-borne infection that is thought to infect around 2.5% of the world's population - some 170 million people.

The availability of new, more effective therapies for hepatitis C virus have raised the tantalising prospect of being able to eliminate the infection on a global basis,  although there are still significant obstacles to overcome.


Viral hepatitis - which generally means hepatitis B and C - “kills more people every year than HIV, malaria and tuberculosis combined, but has not had the same level of resources committed to it,” according to Charles Gore, who is chief executive of the Hepatitis C Trust in the UK and president of the World Hepatitis Alliance (WHA).

AIDS Specialist Advocates Sweeping Approach to Battle Against Hepatitis C

Could hepatitis C be the next communicable disease to come under a targeted attack in B.C.?

It will be if HIV/AIDS expert Dr. Julio Montaner has his way.

Montaner said Tuesday that even if the virus is eradicated among baby boomers, that won’t stop its continued spread.


USA-Lack of Insurance Bars Some from Hepatitis C Treatment

Survey data from 2001 to 2010 show that lack of insurance kept some people with hepatitis C virus from getting treatment.

Recently, more effective and well-tolerated drugs have been developed to treat hepatitis C, removing many of the discouraging side effects of older drugs. The infection is curable and transmission can be prevented, researchers write in the American Journal of Gastroenterology.

But for the more than three million people in the U.S. who have chronic liver disease from hepatitis C, there are still two important barriers to getting treatment, said lead author Dr. Ivo Ditah from the Mayo Clinic in Rochester, Minnesota.

UK-Prime Minister Apologizes for Tainted Blood Scandal That Infected Thousands in '70s, '80s

LONDON— British Prime Minister David Cameron on Wednesday apologized to thousands of patients who were infected from contaminated blood during the 1970s and 1980s.

Tainted government blood products and transfusions infected an estimated 2,500 people with the hepatitis C virus and HIV from 1970 to 1991. The scandal has been called the worst treatment disaster in the history of Britain's public health care system.


Cameron's apology came after a six-year official inquiry was completed. The probe said more should have been done to screen blood and donors in the early 1990s, and that the collection of blood from prisoners should have stopped earlier.