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Alan Franciscus

Editor-in-Chief

HCV Advocate



Thursday, February 5, 2015

Africa: Cultural practices may be driving hepatitis C infection rates in West Africa

Reports that suggest high rates of serologic false positives and low levels of viremia have contributed to uncertainty regarding the burden of active hepatitis C infection.

 A lack of knowledge surrounding the transmission and progression of hepatitis C virus infection in West African countries may be contributing to the spread of the disease, results of a study published in Clinical Infectious Diseases indicate.

"This is a small study conducted at a blood bank in a teaching hospital in Ghana," explained Jennifer Layden, MD, PhD, of Loyola University in Chicago, Ill., in a press release. “The goal is to further understand whom is affected by hepatitis C and to identify specific next steps in intervention and prevention.”

More than 180 million people have hepatitis C. In developed countries, hepatitis C infection is often transmitted through intravenous (IV) drug use, but this may not be the case in West Africa, noted the investigators.


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PHOTON-2 Study Addresses Combination Hepatitis C Pill For HIV+ Patients

MedicalResearch.com Interview with:
Prof Jean-Michel Molina
Maladies Infectieuses et Tropicales, Hôpital
Saint-Louis, Paris France

Medical Research: What is the background for this study? What are the main findings?

Prof. Molina: Treatment of co-infected patients is complicated by drug drug interactions with HIV drugs, and the news DAAs are not very potent on HCV G2 and 3 infections.

Medical Research: What should clinicians and patients take away from your report?

Prof. Molina: The simple combination of sofosbuvir plus ribavirin (available as a generic drug) provides potent response rates above 80% for co-infected patients with all genotypes, with limited drug drug interactions with HIV drugs.

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$1,000 Hepatitis C drug in spotlight at healthcare hearing

A $1,000-drug used to treat Hepatitis C was a hot-button topic at a California Senate committee hearing Wednesday.

"We are really concerned about the high cost of specialty drugs, which have just continued to increase year after year and are going to end up taking 50 percent of the budget of all of the pharmaceutical costs," Pharmacy and Adult and Family Medicine Executive Director at Kaiser Permanente Dr. Sameer Awsare said.

But drug prices were just one part of the bigger problem of rising healthcare costs. Speakers said that physician fees and hospital facility fees are also a major factor. The growing bill means that consumers, including people with employer-sponsored insurance, are being asked to shoulder more costs out of pocket. In fact, the Health Care Costs Institute released a new report this week finding that people with insurance through work paid 15 percent of their medical expenses out of pocket in 2013, up 6.9 percent year-over-year.

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Canada: Endoscope didn't cause hepatitis C outbreak at Kitchener clinic

Investigators from Region of Waterloo Public Health are still trying to figure out why five patients who had colonoscopies at a Kitchener clinic on Christmas Eve in 2013 were infected with hepatitis C. 
"We know that the endoscope that was used that day was not the cause. All of the clients had different endoscopes. So that wasn't what links those five patients together," said Dr. Liana Nolan, the medical officer of health for Waterloo Region, in a interview with Colin Butler on The Morning Edition Wednesday.

"This is strong evidence of patient to patient transmission of hepatitis C due to a lapse in infection prevention and control practices at the clinic," the report said. 

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Photo gallery: Hepatitis C more curable than ever

New and costly drugs have revolutionized the treatment of hepatitis C. Kansas City Care Clinic (formerly the Kansas City Free Clinic) has been successfully treating patients, many of whom are uninsured. The clinic has also helped patients find financial assistance for the extremely costly medications.

Read the personal stories and see the photos here

Read more here: http://www.kansascity.com/news/local/article9314771.html#storylink=cpy

Predictors of Treatment Response —Alan Franciscus, Editor-in-Chief

In the past, there were many factors that predicted successful treatment outcome.  Today, that list is much longer and is somewhat dependent on the particular HCV inhibitor used to treat hepatitis C. 
This article is about the negative predictors of treatment response—genotype, subtype, cirrhosis, prior treatment response and viral load.
 
Genotype: 
The most dramatic current negative predictor of treatment response is genotype 3.  The current standard of care for treating HCV genotype 3, a combination of sofosbuvir (Sovaldi) plus ribavirin for 24 weeks, has an overall cure rate of 93%. Among those in the group who had never been treated (treatment naïve), the cure rate was 93% for those without cirrhosis compared to 92% for those with cirrhosis. Among treatment experienced patients in this test group, the cure rate was 85% for those without cirrhosis compared to only 60% for those with cirrhosis.   Future treatments are needed for people with genotype 3 that have higher cure rates with shorter treatment durations, and which work in cirrhotic patients who have not responded to prior treat­ment.   


Subtype: 
Subtype has long been known to affect treatment outcome.  In regards to genotype 1, subtype 1a is generally harder to treat.  If we look at VIEKIRA PAK to treat HCV genotype 1a without cirrhosis, adding ribavirin is indicated.  There is no recommendation to add ribavirin to VIEKIRA PAK for treatment of genotype 1b without cirrhosis.  


Cirrhosis: 
People with cirrhosis have always been harder to cure than those without it, although now it is not as difficult as in the past. The recommended treatment duration for genotype 1a patients with cirrhosis is 24 weeks with VIEKIRA PAK plus ribavirin.  There is a note that 12 weeks can be considered for some patients based on prior treatment history. 


Treatment-Experienced:  
Patients without cirrhosis can be treated with HARVONI for 12 weeks. Treatment experienced (but not cured) patients with cirrhosis can be harder to cure, so 24 weeks treatment with HAR­VONI is recommended.   


HCV RNA or Viral Load:
In the Full Prescribing Information for HARVONI for genotype 1, there is a footnote about the recommended treatment duration saying that “HARVONI for 8 weeks can be considered in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL.”  This consideration is based on the ION-3 study of 123 patients with baseline viral loads under 6 million IU/mL who were treated for eight weeks.  The cure rates were 97% (119 of 123 patients).   This is only true with HARVONI.  The viral load thresholds need to be studied in all of the newer therapies.

 
Even now, matching a person’s characteristics to the specifics of the HCV drugs can help cure most people.  The future of hepatitis C treatment holds the promise that, when matched with all of a patient’s characteristics, new medicines or combinations of medications will be able to treat and cure everyone with HCV. 


http://hcvadvocate.org/news/newsLetter/2015/advocate0215.html#4

Wednesday, February 4, 2015

Pricing wars heat up over hepatitis C drugs

Announcing its first dividend, annual revenue that doubled the prior year's performance and a $15 billion buyback plan wasn't enough to buoy Gilead Sciences' shares when it dropped a bomb during its fourth-quarter earnings conference call: Discounts on the company's hepatitis C drugs this year will be 46 percent, way more than investors and analysts expected.

"That really escalated quickly," Brian Skorney, an analyst with Robert W. Baird, wrote in a note to clients Wednesday. The discount "is meaningfully worse than expectations" in the 25 to 30 percent range, and as a result, Skorney lowered his estimate for Gilead's hepatitis C revenue by 20 percent to $12.9 billion.

Gilead said part of its adjustment reflects a shift toward more patients who are covered by Medicaid and the Veterans Administration receiving the drugs at rebates of more than 50 percent.

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