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Alan Franciscus

Editor-in-Chief

HCV Advocate



Tuesday, January 20, 2015

AASLD 2014: Ledipasvir and Sofosbuvir in African Americans —Alan Franciscus, Editor-in-Chief

This is the last of the AASLD 2014 conference coverage (I promise!), but there was one more study I thought was important to discuss.
 
The Safety and Efficacy of Ledipasvir and Sofosbuvir in African Americans:  A Retrospective Analysis of Phase 3 Data – L Jeffers et al.

The information from the Phase 3 studies of ledipasvir plus sofosbuvir, and of ledipasvir, sofosbuvir plus ribavirin, was compiled, and the information about the African American patients was extracted.  The treatment durations in these studies were 8, 12 or 24 weeks.  The patient characteristics of the African American were generally older, higher Body Mass Index, more likely to have IL28B non-CC (a variation that is less likely to respond to treatment) and lower ALT (liver enzyme levels).

The combined results from all of the phase 3 studies showed the overall cure rates among African Americans to be similar to the non-Blacks in the study groups.   The authors did note that “Although high SVR rates were observed, the limited number of black patients with cirrhosis precludes definitive conclusions in this subpopulation.”  In other words it would be hard to draw conclusions regarding effectiveness of the drugs when comparing African Americans and the other groups because there were so few African Americans in the study who had cirrhosis.
 
Comments: When interferon-based therapy was the standard of care to treat hepatitis C, African Americans had much lower cure rates compared to most other races.  Now that the standard of care is interferon-free therapies, African American cure rates are the same as the cure rates seen in other races.  Many old ‘facts’ die hard; so let’s put this one to rest and get the message out that that African Americans respond just as well to interferon-free therapies as other populations. 
 
This was a presentation that was posted to NATAP courtesy of Jules Levin.


http://hcvadvocate.org/news/newsLetter/2015/advocate0115_mid.html#2

After decades with hepatitis C, liver transplant gives man life back

Michael Trevino likely contracted hepatitis C during his military service in Vietnam. It was cured, but doctors told his wife, Ileana, just after his successful transplant that his old liver still had become cancerous.

The way J. Michael Trevino sees it, his life was saved twice.

Read more...

Monday, January 19, 2015

UK: Apology is wanted by patients who are contaminated by tainted blood

IT WAS a transfusion that was supposed to help Sally Vickers deal with a blood condition, but she says it has given her a death sentence.

Those are the stern words from the 53-year-old who was pumped full of contaminated blood more than 30 years ago.

As a result she contracted hepatitis C – a condition that affects the liver – and has resulted in her giving up work, feeling tired and knowing it could one day kill her because the condition she was born with stops her getting treatment for the virus.

Read more...

Are Anesthesiologists Finally Recognizing the Importance of Infection Control?

New York—When it comes to the delivery of anesthesia care, infection control matters—and infectious disease professionals think it is high time their counterparts in anesthesiology recognize that.

They should be pleased then that the issue was the topic of discussion during a session entitled “Infection Control Issues Impacting Anesthesia Practice: What’s the Evidence?” held here at the New York State Society of Anesthesiologists’ (NYSSA) 68th Annual PostGraduate Assembly (PGA) in Anesthesiology. The speakers emphasized the importance of infection control practices in the delivery of anesthesia by citing numerous examples. For instance, they noted that during anesthesia care Loftus RW et al (Anesth Analg. 2014 Jun 16. [Epub ahead of print]; PMID: 24937346) found a within- and between-case Enterococcus faecalis transmission rate of 11% to 23%; furthermore, several hepatitis B and C and other infectious outbreaks in health care settings over the past 15 years have been attributed to mishandling of medications, fluids, syringes, needles and cannulae by anesthesia professionals. However, the speakers also emphasized that some published infection control recommendations, including a provision of US Pharmacopeia (USP) Chapter <797>, for example, present unique challenges to anesthesia professionals.

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Canada: Vancouver man denied access to lifesaving new Hepatitis C drugs

A resident of Vancouver’s Downtown Eastside is speaking out about the cost of treatments for Hepatitis C. Brody Williams says the only effective options left cost close to $100,000.

Brody Williams has battled the disease for years, undergoing numerous treatments. He’s one of 200,000 Canadians struggling with the virus.

But Williams isn’t getting the drugs. They come with a price tag of $75,000 – $100,000 for a course, and neither the federal Ministry of Indian Affairs, nor B.C.’s medical system will pay because he’s had four different drug treatment protocols already.

Read more...

Canada: Cape Breton medical officer calls for more hepatitis C screening

About 5,000 Nova Scotians have contracted the infection. In 2013, Cape Breton recorded the second-highest rate of hepatitis C in the province — or about 24 per cent of all hepatitis C cases. 

SYDNEY — Cape Breton’s medical officer of health is encouraging the screening of patients for hepatitis C as a result of staggering rates of the disease.

Dr. Monika Dutt recently offered the advice to close to 60 doctors taking part in a family medicine gathering in Sydney.

“We have rates that are about double what we’re seeing in the rest of the province,” Dutt said in an interview with The Chronicle Herald on Sunday. “It’s something that been increasing over quite a few years now.”

Read more...

Genotype 2: Prevalence, Cure and Viral Diaspora —Alan Franciscus, Editor-in-Chief

In the past genotype 2 and 3 information has been lumped together.  More recent information has emerged that there are clear differences between these 2 genotypes with respect to prevalence, disease progression and treatment cure rates. Interestingly, there is also substantial data about how genotype 2 migrated from Africa to other parts of the world via the slave trade in the 16th,17th, and 18th centuries. 

Prevalence
There are 7 HCV genotypes identified numbered 1 through 7.  The most common genotypes worldwide include:
  • Genotype 1 (46.2%)
  • Genotype 3 (30.1%)
  • Genotype 2 (9.1%)
  • Genotype 4 (8.3%)
  • Genotype 6 (5.4%)
  • Genotype 5 (.8%)
So far, there has only been 1 person identified with genotype 7.  Thirteen to 15% of people with hepatitis C in the United States are infected with genotype 2.   

As noted above, 9.1% of the population worldwide has gentoype 1.  This translates to about 16.5 million people infected with HCV genotype 2 globally.  Areas that have a prevalence of 10% or greater include:
  • Central Latin America— 19.3%
  • East Asia—15.3%
  • High-income Asia Pacific—24.5%
  • High-income North America—12.0%
  • Southeast Asia—18.2%
  • Western Europe—10.8%
  • West Sub-Saharan Africa—23.0%
Subtype
The most common genotype 2 subtypes include 2a, 2b, 2c, but there have been 15 other subtypes identified. 

Origins
Technology is amazing!  Science can analyze the genetic make-up of hepatitis C virus to estimate the origin, date it and track the viral migration.  Previous studies were able to deduce that genotype 2 originated in West Africa at least 500 years ago. 

In the current study “Phytogeography and molecular epidemiology of hepatitis C virus genotype 2 in Africa,” by P.V. Markov et al., the authors wanted to understand where genotype 2 originated.  The study group looked at all the known subtypes of genotype 2, then concentrated on the geographical area of Guinea-Gambia, which had been theorized as the origin of genotype 2.  Using a process called the molecular clock the authors confirmed that Guinea-Gambia was indeed the source of genotype 2.  Genotype 2 then spread from West Africa to Central Africa. 

Blood-to-blood contact transmits hepatitis C.  This being the case, it is likely that the spread of hepatitis C through Africa occurred over hundreds of years.  So what made hepatitis C increase in such large numbers and spread throughout all of West Africa and Central Africa faster?  It is most likely that hepatitis C was spread throughout Africa by European campaigns to treat endemic diseases in Africa with injectable medications.  Trypanosomiasis (sleeping sickness), syphilis, yaws, malaria, and leprosy were (and some still are) rampant in Africa.  Treating these and other diseases was well-intentioned but, unfortunately, the needles were reused or not properly cleaned.  Millions of unsafe injections were given in Africa before the advent of disposal needles, which contributed to the spread of hepatitis C in Africa.

With regard to how genotype 2 was spread beyond Africa that question has also been answered based on the same genetic technology.  The introduction of genotype 2 into America—particularly in Central and South America—was the result of the transatlantic slave trade from West Africa.  This is called viral migration. 

This is the same way that yellow fever (in the same viral family as the hepatitis C virus—flavivirus family) and other diseases common in Africa were introduced into the Americas by the same transatlantic slave trade.  Similarly, European diseases such as smallpox, measles, tuberculosis, and influenza were introduced into the Americas by the Europeans.

Genotype 2 is also common in Europe not only because of the slave trade, but also due to immigration. France is believed to have contributed to the migration of genotype 2 from their West African colonies to other colonies in Morocco, Quebec, and Vietnam (French Indochina).  It appears that genotype 2i in France was introduced by West African conscripts trained and stationed in southern France during World War I—but this needs to be confirmed by larger studies. 

Genotype 2 did not only migrate from Africa to the Americas and Europe, it also migrated from South America to Asia.  This occurred by way of the slave trade from Java, Indonesia to Surinam (South America) and then back to Indonesia in the 20th century.  

Disease Progression
Genotype 2 does not increase the risk for HCV disease progression.  This is in stark contrast to genotype 3, which has been found to increase the risk for steatosis (fatty liver) and HCV disease progression, including higher rates of fibrosis and steatosis. 

Treatment
The American Association for the Study of Liver Diseases (AASLD) and the Infectious Disease Society of American (IDSA) recommend that genotype 2 should be treated with the combination of Sovaldi (sofosbuvir a pill taken once-a-day) plus ribavirin (a pill taken twice dai­ly—dosage based on a person’s body weight). The duration of treatment with Sovaldi is 12 weeks. 
The cure rates are:
  • Treatment naïve:  97% (no cirrhosis 97%; cirrhosis 100%)
  • Treatment experienced:  (no cirrhosis 91%; cirrhosis 88%)
AASLD/IDSA also recommend that previous non-responders to therapy can include peginterferon in the 12 weeks of therapy.  Patients who were previous non-responders with cirrhosis may benefit by extending treatment duration to 16 weeks.

There is such a high cure rate for genotype 2 that there is very little research looking at new therapies to treat HCV genotype 2.  However, due to the high cost of current treatments, newer inexpensive therapies would be a welcome addition to the treatment landscape of genotype 2, especially in resource-poor countries.

http://hcvadvocate.org/news/newsLetter/2015/advocate0115_mid.html#1