Editorial | Needle exchanges

The alarming epidemic of HIV in Southern Indiana tied to intravenous drug abuse underscores the wisdom of Kentucky lawmakers who included an option for sterile needle exchanges in the comprehensive heroin bill they passed this session.

In Indiana, the surge of HIV cases among 80 people linked to tiny Scott County — population 24,000 — has attracted national headlines and caused Gov. Mike Pence, who has opposed needle exchanges, to reverse course.

Kentucky’s heroin bill was signed into law Wednesday by Gov. Steve Beshear and could result in many saved lives if communities take advantage of the option to offer needle exchanges through local health departments.

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Australia: World first trials for hepatitis C wonder drug in Sydney's maximum security jails

Two of NSW's maximum security jails are the location for a world-first trial of a new wonder drug that could stop the spread of the blood-borne disease hepatitis C through the prison populations.

Prisoners at the Lithgow and Goulburn jails are being recruited to take part in the treatment program, which it is hoped will eventually rid the institutions of the disease and potentially save the lives of thousands suffering chronic infections.

About a third of all prisoners in NSW jails are infected with chronic hepatitis C, which spreads rapidly through prisons by blood-to-blood contact including sharing of needles, syringes and other drug paraphernalia, tattoo equipment and from fights.

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UK: Amends must be made to the victims of the contaminated blood scandal now

AFTER decades of campaigning, the decision to hold a public inquiry into what has been dubbed the biggest treatment disaster in the history of the NHS was welcomed by the victims who were infected with HIV and hepatitis C through contaminated blood.

Last week it was a very different story as the publication of the final report was met with anger and accusations of a "whitewash".

The chair of the inquiry Lord Penrose, apportioned no blame for the tragedy and did not conclude that the infection of nearly 3,000 people in Scotland with HIV and hepatitis C from blood transfusions and products used to treat bleeding disorders could have been prevented.

But what the final report of the inquiry - which runs to five volumes - does document is a series of shocking revelations about the events which led to the disaster. The scale of the suffering is also laid bare with the harrowing stories detailed in the report - such as a mother who unwittingly infected her young son with HIV believing she was giving him the best treatment for haemophilia.

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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.

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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-naïve 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

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.

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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).

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