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Alan Franciscus
HCV Advocate
HBV Advocate

Drugs in Development / Clinical Trials—Updated October 13, 2014

Monday, October 20, 2014

Pill Injectors at Higher Risk for Hepatitis C than Heroin Injectors

This month the American Journal of Public Health published an article with surprising new findings: People who inject prescription opioid analgesics (pain pills) are 5 times more likely to be hepatitis C infected than people who inject other drugs like heroin or cocaine.

The study also reports that people who share injection equipment, such as cookers, cottons and water are 4 times more likely to be infected with hepatitis C than people who do not share injection equipment. Last week I spoke with Jon Zibbell, researcher with the Division of Viral Hepatitis at the Centers for Disease Control and lead author on the report, to ask about the science behind these extraordinary findings.


Hepatitis C Around the World: Hepatitis C in Egypt, by Alan Franciscus

—Alan Franciscus, Editor-in-Chief  

Egypt has the highest prevalence of chronic HCV of any country worldwide—estimated at a rate of up to 8.5% in 2008, but declining to 7.3% in 2013. The decline in the rate of chronic HCV was because of two factors—deaths related to HCV or people with HCV who died of other causes, and because of the number of people successfully treated with HCV medications.

The number of people in Egypt who have actually been diagnosed totals only 15% of the HCV-infected population. Annually, there are 125,000 newly diagnosed chronic HCV cases.
HCV genotype 4 is the most common strain in Egypt followed by HCV genotype 1 (90% and 10% respectively).

Blood-to-blood contact transmits hepatitis C.  In Egypt the most common transmission routes include:
  • Sharing needles and works for injection drug use (medical, traditional practices and recreational use),
  • Receiving a blood transfusion or an organ transplant,
  • Dental practices,
  • Circumcision,
  • Medical care from local informal health providers and centers.
Some of the transmission is the result of a mass campaign in the 1960's though the 1980's to control schistosomiasis infection—a parasitic disease transferred by snails to humans wading in water while working in rice fields. At that time, schistosomiasis was treated with injections of the drug "tartar emetic" using unsterilized and re-used syringes.

Today, as in the past, the majority of infections are the result of transmission from unsafe medical practices. Culturally, Egyptians have many needless injections and blood transfusions using unsafe blood, needles and tools. This includes:
  • Unsterilized medical and dental instruments,
  • Gloves used on multiple patients,
  • Blood spills not cleaned up,
  • One-use vials used on more than one patient,
  • Used syringes
Blood Safety Training
Egypt has a national plan in place to train medical staff and the population (urban and rural) about blood safety. Egypt is a poor country that has many cultural practices that will need to be addressed before blood safety practices can change.

In 2013, there were 153,000 deaths recorded—33,000 related to HCV; 120,000 deaths for all-cause mortality. HCV can be a contributing factor for non-HCV related deaths so the actual number of deaths related to HCV might be higher.

The Ministry of Health treats 50,000 patients a year; Health Insurance Organization treats 10,000; 5,000 patients paid cash for treatment.
Note: The HCV protease inhibitors—boceprevir and telaprevir—only have antiviral activity against HCV genotype 1.

The Ministry of Health has a national treatment program that provides free treatment for most patients.  By 2013, the total number of patients with HCV treated reached 350,000.  Until recently pegylated interferon plus ribavirin was the standard of care.  The cure rate in the Egyptian population with HCV genotype 4 was 54-59%. 

Now there is Sovaldi (plus pegylated interferon and ribavirin) which has a cure rate for HCV genotype 4 of 96% (more than 9 out of 10 people).  There are even more drugs that are being studied to treat hepatitis C genotype 4 that may be able to cure everyone, but these drugs are expensive. 
The drug company that makes Sovaldi, Gilead, has made a deal with the Egyptian government that will make the course of treatment much cheaper for Egyptians.  Twelve weeks of Sovaldi will cost $300 per Egyptian patient compared to $84,000 per US patient.  

Treating millions of Egyptians and educating/ training 85 million people about prevention measures seems like an incredibly uphill battle for any country, especially a country that has a large urban and rural poor population that is recovering from a revolution.  But Egypt has one of the oldest civilizations in the world and has survived thousands of years, so conquering HCV may just be a matter of a united national will.


Senate Lawmaker Eyes Hearing on the Cost of Hepatitis C Treatments

Responding to the ongoing controversy over the prices for new hepatitis C treatments, U.S. Sen. Bernard Sanders (I-Vt.) will probably hold a hearing – possibly before the year ends – to examine how the cost is affecting the U.S. Department of Veterans Affairs, according to his spokesman. Sanders is chairman of the Senate Committee on Veterans’ Affairs.

His interest in a hearing comes as the expense of these medicines helps fuel a national debate over the rising cost of prescription drugs. New hepatitis C treatments, in particular, have caused a ruckus, because they promise cure rates exceeding 90%, which is prompting a sudden surge in prescribing – and subsequent concerns over the effect on insurance budgets.


HCV nucleotide analogue polymerase inhibitor associated with cardiac dysfunction

Fourteen of 34 patients with hepatitis C virus infection who were treated with the novel nucleotide analogue polymerase inhibitor BMS-986094 had some evidence of cardiac dysfunction, according to a new report.

BMS-986094 (Bristol-Myers Squibb) was developed as a treatment for HCV, but clinical development was discontinued in 2012.

“Treatment for chronic HCV infection is evolving from interferon-based therapy to direct-acting antiviral agents, yet some safety concerns have arisen involving cardiac toxicity,” Tariq Ahmad, MD, MPH, and colleagues wrote.

Hep C Virus in Tears Inspires Research

CHENNAI: Hepatitis C can hide in the darndest places. And yet, it was the detection of virus in one of the most innocuous parts of the human body that led to scientists making a 3D model of HCV (Hepatitis C Virus). Researchers at a lab in Sankara Nethralaya detected quite a few cases where patients who had no manifestation of Hepatitis C in their blood streams, had tears filled with the virus. At the moment, screening for viruses like Hep B and C and HIV is only done when the eyes are removed for transplant. “As a standard protocol we run these tests and find that the incidence is two among every 100 pairs of eyes harvested. We do not use these eyes, but we don’t really test for these viruses unless someone is going for surgery,” said Dr Anand Parthasarathy, CMO at Dr Vasan’s Eye Hospitals.

The team at SN dug deeper. “The tear fluids are tested in labs for various ophthalmological procedures, which is how they found the virus there. There is a high possibility that it could spread to their bodies or in the case of them donating their eyes, pass on to the person receiving the transplant,” explained Dr Samuel J K Abraham, director of the Nichi-in Centre for Regenerative Medicine — a Japanese-Indian collaboration.

To find the answers to why this happened, researchers got to work and used a synthetic polymer scaffold, developed in Waseda University in Japan, to create the world’s second 3D lab culture of the Hep C Virus.

Read more....

Ebola Hysteria, by Alan Francicus

—Alan Franciscus, Editor-in-Chief  

There is a lot of fear right now about Ebola.  It has also turned into a political circus like every other issue in this country.  In the next “Mid-Month Edition” of the HCV Advocate, I will discuss what we know about the origin of the hepatitis C virus.  We have not yet discovered the reservoir of the Ebola virus, but scientists acknowledge that there is one because it emerges, does damage, burns itself out and goes back into the unknown reservoir.  The Ebola virus re-emerges at another time when people come into contact with the hidden reservoir.  In this country, the reality is there have been only two unfortunate cases.  The cases that occurred in this country were due to lapses in safety.  The protective suits the healthcare workers used had gaps through which the Ebola virus could come into contact with the skin.  These brave healthcare workers became infected with the Ebola virus.  They are receiving the best possible medical care and hopefully they will recover soon.  We have learned from these errors, and the government is setting measures in place to make sure that no one else will be unnecessarily exposed to this virus.

The good news today was that the people who came into contact with the first patient and the other healthcare workers were symptom free and taken out of quarantine.  That answers a lot of questions and should reassure us all. 

We know how the Ebola virus is transmitted.  We also know that the Ebola virus is not transmitted to people through the air. 

From the Centers for Disease Control and Prevention (CDC):
When an infection does occur in humans, the virus can be spread in several ways to others. Ebola is spread through direct contact (through broken skin or mucous membranes in, for example, the eyes, nose, or mouth) with:
  • Blood or body fluids (including but not limited to urine, saliva, sweat, feces, vomit, breast milk, and semen) of a person who is sick with Ebola
  • Objects (like needles and syringes) that have been contaminated with the virus
  • Infected animals
  • Ebola is not spread through the air or by water, or in general, by food.  However, in Africa, Ebola may be spread as a result of handling bushmeat (wild animals hunted for food) and contact with infected bats.  There is no evidence that mosquitos or other insects can transmit the Ebola virus. Only mammals (for example, humans, bats, monkeys, and apes) have shown the ability to become infected with and spread Ebola virus.
If we want to focus on real dangers, there are many other harms and deaths in the U.S. that we have some control over such as (no judgments – just the numbers):
  • The Flu kills from 3,000 to 49,000 a year:  Get the annual flu shot; wash your hands regularly for at least 20 seconds after you use the toilet or come into contact with germs;
  • Smoking cigarettes kills more than 400,000 deaths a year:   hink about quitting or cutting back
  • Automobile accidents kill more than 32,000 people a year:  Wear a safety belt, don’t drive under the influence; drive defensively
Read this:  Ebola:  The Natural and Human History of a Deadly Virus, by David Quammen
Skip this:  The Hot Zone, by Robert Preston is a very entertaining book.  Most experts have commented that it exaggerates the symptoms, uses too much blood, gore and gives a visual that is not a realistic picture of Ebola.  The author has even admitted that he wants to rewrite some portions of the book that describe some of the symptoms and death from Ebola. 

Sunday, October 19, 2014

180 Million People Have This Disease, Yet Few Are Aware of It

Infectious diseases are everywhere, and according to Smart Global Health they're blamed for 16% of global deaths each year. Breaking these deaths down based on data from the World Health Organization, these include close to 4 million respiratory infection deaths annually (e.g., pneumonia), malaria -- which can claim up to 3 million lives per year -- HIV and AIDS, which account for roughly 2.5 million deaths, and tuberculosis, which is the primary cause of death for about 1.7 million people annually.

Right now the disease everyone's paying attention to is Ebola, a virus that presents with flu-like systems but can have serious, and often fatal, consequences. But putting things into context Ebola hasn't become a huge global killer. Thus far the death toll has crossed 4,000. This is a saddening figure, but it pales in comparison to the annual death toll from HIV/AIDS or tuberculosis, for example.

180 million have this disease, but few know it!
There is, however, another deadly disease in existence that, based on data from the World Health Organization, affects an estimated 180 million people, or 3% of the world's population. Though it may not be as lethal as Ebola in terms of how quickly it kills it victims, this global disease can, in its chronic state, lead to liver damage, liver disease, liver cancer, or even death. Within just the U.S., it's a disease that claims 15,000 lives annually.