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Alan Franciscus

Editor-in-Chief

HCV Advocate



Wednesday, March 18, 2015

Federal judge lets NY prison hepatitis policy claim proceed

A lawsuit that says New York state officials, including former Gov. George Pataki, supported a policy to trim medical costs that led to the denial of hepatitis treatment for some inmates can proceed to trial, a judge has ruled.

In the decision entered in the public record Monday, U.S. District Judge Raymond J. Dearie in Brooklyn ruled that a former prisoner identified only as "K. Doe" had adequately asserted his $250 million claim that Pataki and other government officials created and implemented a policy to withhold from state prisoners their positive hepatitis status and deny treatment as a cost-saving measure.

Melissa Grace, a spokeswoman for the state attorney general's office, which is representing the defendants, including Pataki, said the office had no comment.

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Fight on against Hepatitis C in Wisconsin and Minnesota

Superior, WI (NNCNOW.com) -- It's often referred to as a silent killer so Northland health care professionals have come together to learn more about Chronic Hepatitis C.

According to the Wisconsin Department of Health Services an estimated 74,000 people in Wisconsin are infected with Hepatitis C.

On Tuesday in Duluth and Superior, health care professionals learned how to identify patients at risk of Hepatitis C, and how to make appropriate referrals for diagnosis and treatment.

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Charity attacks Gilead over hepatitis C drug restrictions

(Reuters) - Charity Medecins Sans Frontieres has accused U.S. drugmaker Gilead Sciences Inc GILD.O of restricting access to its breakthrough hepatitis C drug Sovaldi in developing countries as it tries to protect profit margin in wealthier nations.

MSF, also known as Doctors Without Borders, said Gilead's restrictions aimed to stop discounted supplies of Sovaldi being diverted to patients from rich countries, but that the effort had resulted in "multiple restrictions and demands" on people receiving treatment in poor countries.

It said Gilead was excluding people without national identity documents, a move that hurts migrants, refugees and marginalized patients.

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The Five: Diabetes —Alan Franciscus, Editor-in-Chief

If you notice, I did not title this article HCV and diabetes.  That is because new studies have not found a direct link between hepatitis C and diabetes—that is type 2 Diabetes mellitus.  However, it is still being studied, and it keeps coming up so the complete story may not be over.   Regardless, it is an important health issue facing people living with hepatitis C especially those who are considered part of the ‘Baby Boomer’ generation.  This month’s Five is about diabetes and how it relates to people with hepatitis C and why it is important to be tested for it, how to treat it and how it may improve the chances of being approved for HCV treatment. 

Diabetes affects approximately 40 million Americans. 

1. At-Risk Populations:  People who are more likely to develop diabetes include people 45 years old or older, being overweight or obese, having a parent, brother or sister with diabetes, having a genetic disposition to developing diabetes.  Certain races and ethnicities such as African Americans, Hispanics, Alaskan Natives, American Indians, Asian Americans, Native Hawaiians or Pacific Islanders are more prone to having diabetes.

2. Symptoms:  The most common symptoms of diabetes include increased thirst and hunger or appetite, dry mouth, frequent urination (peeing), fatigue (feeling tired), unexplained weight loss—even when eating more food.  In extreme cases, people may experience loss of consciousness.

3. Complications:  Over time, left untreated or uncontrolled diabetes can lead to very serious complications including mental confusion, blurred vision, sores or wounds that are slow to heal or don’t heal, sexual problems, heart and kidney disease, blindness, peripheral neuropathy, amputation, and death.

4. Treatment:  Diabetes can be treated and controlled with diet, exercise, and medications.  It is important to be monitored regularly.

5. HCV Treatment:  Many insurance companies and state Medicaid programs are restricting HCV treatment to those with severe fibrosis and cirrhosis.   There are other conditions that may increase the chances of being approved for HCV treatment—Type 2 Diabetes mellitus is one of the conditions that may increase the likelihood of being approved for treatment.  (See: AASLD-ISDA Recommendations for Testing, Managing, and Treating Hepatitis C 2014: When and in Whom to Initiate Treatment).  Talk to your medical provider to find out if you should be tested for diabetes.  If you have diabetes—check with you medical provider about HCV treatment.

The Bottom Line:  Diabetes is a serious disease that has many consequences.  The United States Preventive Services Task Force (USPSTF) now recommends testing adults for diabetes who have high blood pressure (greater than 135/80 mm Hg).  The USPSTF is currently in the process of updating their guidelines to include screening adults:
“Having factors that increase the chances of developing high blood sugar or diabetes, such as being 45 or older, being overweight or obese, or having a close relative with diabetes.”
The updated guidelines should be released in the coming months.


http://hcvadvocate.org/news/newsLetter/2015/advocate0315_mid.html#3

India, Pharmacy to the Developing World, Must Honor IP Rights

The United States and India are locked in a vitriolic debate over intellectual property rights in the pharmaceutical sector. The tension between pharmaceutical patents and access to affordable medicines took center stage during President Obama’s three-day visit to India in January. For several years the United States has been increasing the pressure on India to adopt intellectual property protections similar to those of the U.S. and the European Union, without avail. According to the 2015 U.S. Chamber of Commerce’s Intellectual Property Index, India ranks 29th among 30 nations in their protection for intellectual property rights. The report scores nations in several IP dimensions, out of a maximum of 30 points. India scored 7.23 points, only Thailand was ranked lower, while the U.S., the highest-ranked country, scored 28.53 points.[1]

Claiming to be the “Pharmacy to the Developing World”, India argues that their lax intellectual property rights regime is critical to their ability to provide low-cost, quality generic drugs. They are wrong on two counts. First, India needs to honor IP rights, because without effective intellectual property rights, new pharmaceuticals will not be developed and the “Pharmacy to the Developing World” won’t have anything to provide to the developing world, or to anyone. Second, given the quality crisis in the Indian pharmaceutical industry, they shouldn’t be the pharmacy to anyone.

In early January 2015, the Indian government rejected Gilead Sciences Inc’s patent application for its Hepatitis C drug Sovaldi. This comes on the heels of numerous other attacks on pharmaceutical patents. As of mid-2014, India had “denied, revoked or otherwise attacked” the patents of 15 of the approximate 45 patented medicines on the Indian market.[2] The result is a regime of protectionism that coddles Indian industry at the cost of U.S. jobs. The pharmaceutical industry is but one of many industries experiencing such treatment. While the United States has welcomed Indian firms, India has shunned innovative U.S. firms. As described in his Pre-Hearing Statement to the U.S. International Trade Commission, Rod Hunter notes that Indian pharmaceutical firms have enjoyed unfettered access to the sizeable U.S. market.

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Sustained virological response represents a long-term cure for people with hepatitis C treated with sofosbuvir

Almost all patients with hepatitis C virus (HCV) alone or HIV and HCV co-infection who achieved sustained virological response (SVR) to treatment with sofosbuvir (Sovaldi) plus ribavirin or sofosbuvir/ledipasvir (Harvoni) still had undetectable HCV RNA up to two years later, confirming that SVR represents a cure, according to a poster presented at the recent Conference on Retroviruses and Opportunistic Infections (CROI 2015) in Seattle, USA.

The advent of interferon-free therapy using combinations of direct-acting antiviral drugs has brought about a revolution in hepatitis C treatment. Sustained virological response, or continued undetectable HCV RNA at 12 or 24 weeks post-treatment, is considered a cure, but rare cases of apparent late relapse have been observed after this point. (More often, HCV recurrence is due to reinfection.) 

While some studies have detected residual bits of HCV in the blood or the liver after successful treatment, this does not appear to indicate ongoing active disease. Interferon-based therapy has been shown to have a late relapse rate below 5% – usually occurring within two years after treatment – but this is not yet well defined for interferon-free therapy because it is so new.

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Hepatitis C and the Baby Boomer Generation

As the Centers for Disease Control and Prevention release new guidelines regarding testing baby boomers - St. Luke' s Magic Valley is putting a new initiative in place.

"Three quarters of all patients with Hep. C in fact are baby boomers. Unfortunately more than three quarters of them are unknown to us," explained Dr. Brian Berk, Gastroenterologist, St. Luke’s Magic Valley.

Hepatitis C is a contagious liver disease that ranges in severity. It's spread primarily through contact with the blood of an infected person.

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