Welcome to HCV Advocate’s hepatitis blog. The intent of this blog is to keep our website audience up-to-date on information about hepatitis and to answer some of our web site and training audience questions. People are encouraged to submit questions and post comments.

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Alan Franciscus

Editor-in-Chief

HCV Advocate



Thursday, January 22, 2015

Longmont Woman Cured Of Hepatitis C, Credits New Drugs

DENVER (CBS4)- A woman from Longmont has been cured of Hepatitis C during her participation in a clinical trial testing an expensive new drug.

Kim Bossley is thanking the drug Sovaldi for changing her life.

It was 2005 when Bossley learned she had Hep C. Both Kim and her mother were infected during Kim’s birth through a blood transfusion. Kim’s mother died when the disease destroyed her liver.

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Wednesday, January 21, 2015

Hepatitis C Outbreak ~ Lutheran Social Services ~ State of the Union Reaction

Wednesday, January 21 – A Hepatitis C outbreak in Minot has hit a number of elderly residents of a nursing home. Here to discuss Hep C and the problem of public outbreaks is Tracy Miller, state epidemiologist with the Department of Health. ~~~ We share an excerpt from this week’s Prairie Pulse television show as host John Harris visits with Jessica Thomasson, the new CEO for Lutheran Social Services of North Dakota.

Listen to the Podcast here...

Merck Will No Longer Sell its Victrelis Hepatitis C Drug in the U.S.

Rival hepatitis C drugs from Merck and Vertex Pharmaceuticals VRTX +0.21% made a big splash when they debuted in 2011, marking an advance in treatment of the liver disease and a lucrative new market segment. But now the Class of 2011 has almost sunk to the bottom, made obsolete by a newer wave of drugs, a sign of how rapidly the hepatitis C market is changing.

Merck this week notified the FDA that it will stop selling its Victrelis medicine in the U.S. by the end of this year, although the drug will remain available in other countries. The move comes three months after Vertex Pharmaceuticals discontinued U.S. sales of its own Incivek hepatitis C drug.

Both drugs are known as protease inhibitors and when they became available in 2011, they were quickly incorporated into treatment. Victrelis and Incivek each boosted cure rates and shortened treatment durations for many patients when added to the prior standard treatment.

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Snapshots —Alan Franciscus, Editor-in-Chief

Abstract: Low Risk of Liver Decompensation among Human Immunodeficiency Virus/Hepatitis C Virus-Coinfected Patients with Mild Fibrosis in the Short-Term.
  Authors: J Macias et al.  Hepatology. 2014 Dec 24. doi: 10.1002/hep.27674. [Epub ahead of print]

Results and Conclusions: The authors of this study wanted to find out which HIV/HCV patients can safely wait, or wait in the short term for treatment.  This study was conducted during the time that pegylated interferon was part of the treatment regime.  A total of 1729 patients were evaluated (683 patients by liver biopsy; 1046 by liver stiffness measurement) and followed over time. The authors concluded that patients who did not have advanced fibrosis were at “very low risk” of decompensated cirrhosis, at least in the short term.  In this population, a careful watchful waiting is appropriate—in the author’s opinion.

Editorial Comments: I find this study interesting and valuable.  But I think it is a dangerous game to play.  This is a population of patients who typically have faster disease progression—faster than people who are monoinfected.  It may be safe if people are followed very carefully.  But wouldn’t it be easier and safer to treat now and not take the chance of putting people at undue risk?

Abstract: Hepatitis C Virus (HCV) Antibody Dynamics Following Acute HCV Infection and Reinfection among HIV-Infected Men Who Have Sex with Men.
  Authors:  J. Vanhommerig et al. Clin Infect Dis. 2014 Dec 15;59(12):1678-85. doi: 10.1093/cid/ciu695. Epub 2014 Sep 3.

Results and Conclusions: This study identified 63 HIV/HCV coinfected patients who had tested positive for HCV antibodies and HCV RNA (viral load).  The patients were followed for 4 years.  Five of the patients spontaneously cleared HCV and 31 of 43 patients were treated and cured.  In 36 (5 spontaneously cleared; 31 cured) the antibody titers (the measurements) declined.  In 8 of the 31 patients the HCV antibody titers disappeared. 

Eighteen of the patients were re-infected with a dif­ferent strain than the initial one and devel­oped a surge in both antibodies and HCV RNA.  The researchers believed that one patient was re-infected three separate times after the first successful treatment. 

Editorial Comments:  I couldn’t find the entire journal article to find out what type of counseling efforts were offered to the study participants.  This study, however, should remind us we need to educate people about prevention measures.  But what was interesting is that 8 people had undetectable antibody titers in this small study.  On a personal note, I did a demonstration of an HCV antibody test.  I was cured of hepatitis C more than 10 years ago.  The results showed very low reactive results.  I wonder if my antibody titers will become undetectable after time.  This study made me wonder how many ‘Baby Boomers’ became infected many years ago, naturally cleared the virus, and when tested recently had antibody titers too low to register.

http://hcvadvocate.org/news/newsLetter/2015/advocate0115_mid.html#3

Is the Promised Hepatitis C Drug War Finally Here?

Trial involving experimental medications shows six-week cure rate.

A small clinical trial has shown a combination of oral medicines can rid the body of the disease in as few as six weeks, which marks a big advancement in the treatment of hepatitis C.

The drugs included a combination of sofosbuvir and ledipasvir and one of two experimental drugs by Gilead Sciences, GS-9669 and GS-9451.

One obstacle to shorter treatments is cost. Harvoni (ledipasvir-sofosbuvir), the most recently approved rapid cure medication, costs around $95,000. The high price tag for this daily pill taken for 12 weeks poses challenges to public health insurers such as state Medicaid programs. Debates are raging surrounding who should have access to the medications and when.

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Tuesday, January 20, 2015

Georgia: STOP C: Presidential couple joins fight against Hepatitis C

Georgia’s President and the first lady have joined the country's new campaign to intensify the fight against Hepatitis C.

President Giorgi Margvelashvili and his pregnant partner Maka Chichua, posted a picture on the President’s official Facebook page that showed themselves posing with their hands outstretched, showing off words written on their palms that said: "STOP C”.

Georgia declared 2015 as the year of fighting against Hepatitis C.

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TAC, SECTION27 and MSF Applaud India’s Rejection of Patent on New Hepatitis C Medicine

JOHANNESBURG, Tuesday 20th January: The Treatment Action Campaign (TAC), Doctors Without Borders (MSF) and SECTION27 applaud India’s decision to reject a patent application on sofosbuvir, an important new treatment for Hepatitis C. Last Wednesday’s decision paves the way for increased access to more affordable sofosbuvir in India and other countries who choose to implement legal flexibilities available under international law to increase access to the drug. However, existing patents on sofosbuvir in South Africa could block access to the cheaper generic versions that will become available due to the ruling.  The government should therefore urgently finalise the national intellectual property policy to allow South Africa to better protect access to medicines.

Rejection of the patent in India will allow generic manufacturers that have not already signed restrictive licensing agreements with Gilead to produce sofosbuvir at much lower prices than currently available. Research conducted by Dr Andrew Hill at the University of Liverpool, for example, suggests that sofosbuvir can be profitably produced for as little as $102 (R1,182) per 12 week course.

However, patent protection in South Africa prevents open competition, and could block generic versions of sofosbuvir and other new HCV drugs from reaching the domestic market. The same sofosbuvir patent rejected in India was granted in South Africa, and will only expire in 2025. South Africa has also granted multiple ‘secondary’ patents on sofosbuvir, with the latest patent only expiring in 2034. If reforms proposed in South Africa’s draft intellectual property policy are implemented, the number of such secondary patents granted will be dramatically reduced.

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