::: HCV News :::

A closely watched hepatitis C drug being developed by Vertex Pharmaceuticals Inc continues to promise improvement over current treatments, according to analysts who have viewed brief summaries of data from highly anticipated clinical trials.

The summaries, known as abstracts, of data to be presented in full next month at the American Association for the Study of Liver Diseases annual meeting also suggest some limitations and side effects from the drug, telaprevir, analysts said.

"The incremental information provided by Vertex and the (study's) investigators continues to suggest that telaprevir will deliver a sustained virological response (SVR) of 70 percent, or thereabouts, in real world efficacy," Geoff Porges, an analyst with Sanford Bernstein, wrote in a research note.

Other analysts also said the available data appears to add up to an SVR of at least 70 percent in the clinical trial known as PROVE-2. An SVR rate higher than 50 percent is considered to be positive and 75 percent would be viewed as a major success, analysts have said.

SVR is a measure of patients in whom the hepatitis C virus has reached undetectable levels and appears to have been cleared from the system.

The studies are also attempting to show that by adding telaprevir to standard therapy of pegylated interferon and ribavirin there would be a lower relapse rate and significantly shorter treatment duration than without the Vertex drug.

"These results continue to show the potential that telaprevir has to enhance the efficacy of the current standard of care and provide a higher cure rate for patients with hepatitis C virus," said Jason Kolbert, an analyst for Susquehanna Financial Group.

Kolbert did note a potentially worrisome higher patient dropout rate with the PROVE-2 trial than in the earlier PROVE-1 study - 12.5 percent versus 10.9 percent - and the persistence of a troublesome rash seen with many patients who receive the Vertex drug.

Porges said data in the abstracts appear to debunk Vertex assertions that telaprevir could be effectively used without ribavirin, and that ribavirin was the cause of the rash seen in earlier combination studies.

Based on available PROVE-2 data, Porges said, within 12 weeks 25 percent of patients in the telaprevir-plus-interferon group saw the virus rebound from previously low levels compared with 4 percent in the triple-therapy group.

"This means that pegylated interferon with telaprevir but without ribavirin is a non-starter as a regimen for further study," Porges said.

He added that from further analysis of the data, "it is now clear that telaprevir, not ribavirin, was the cause of the rash observed in combination treated patients in PROVE-1."

The limitations "do leave the window open for competitors to enter the market" but do not affect telaprevir's immediate market potential, Porges said.

Vertex shares were up 56 cents, or 1.5 percent, at $39.00 in early afternoon trade on Nasdaq.

Around 10 percent of the country's total population is infected with hepatitis B virus and 3 percent with hepatitis C virus, said the experts at a discussion yesterday.

They said 3.5 percent of the pregnant mothers in the country are affected with hepatitis B.

The discussion was organised by Liver Foundation of Bangladesh to mark the World Hepatitis Awareness Day at Birdem auditorium in the city.

Speaking as chief guest at the discussion, Health Adviser Maj Gen (Retd) Dr ASM Matiur Rahman stressed the need for creating mass awareness about hepatitis B and C to prevent the deadly diseases.

He said suffering from hepatitis B for a long time increases the risk of liver cirrhosis, liver cancer and liver failure.

The adviser said the government is going to include hepatitis B vaccine with national immunisation programme.

"As the treatment of liver diseases is very expensive, its prevention should be our main strategy," said Prof AK Azad Khan of Diabetic Association of Bangladesh (Dab).

He said if the liver diseases reach an advanced stage, only transplantation of liver could be the solution.

Dab is going to start liver transplantation soon at a reduced cost, he added.

Prof AQM Mohsen presented the keynote paper at the discussion chaired by Prof SN Samad Chowdhury.

The experts said it is possible to cure 30 to 60 percent of hepatitis B patients if treated properly.

But the treatment of hepatitis C in our country is not so optimistic and the vaccine of hepatitis C is yet to be invented, they added.

Using disposable syringe and needle can help prevent the spread of the diseases, said the experts, adding that nobody should use toothbrush and razors of others.

They said there is less possibility of transmitting the viruses from sexual intercourse and breast-feeding.

Around 600 million people in the world are infected with hepatitis B and C. Of them, 350-400 million people are infected with hepatitis B and 180 million infected with hepatitis C.

Maj Gen (Retd) Prof AR Khan, Brig Gen (Retd) Prof Abdul Malik, Emad Ul Ameen, Zeba Rasheed Chowdhury, Prof Mohammad Ali of Liver Foundation and Prof M Anisur Rahman also spoke on the occasion.

This was the first time that Bangladesh observed the day with the slogan 'Get Tested.'

European Liver Patient Association (ELPA) and World Health Organisation, Europe have been observing the day since 2004 through different programmes.

This year around 40 countries observed the World Hepatitis Awareness Day.

Most people don't know much about hepatitis C -- until they're diagnosed. Yet infection and mortality rates for hepatitis C are disturbingly higher than they are for HIV:

* 3.5 million people in the U.S. suffer from CHC (chronic hepatitis C); 700,000 are infected with HIV
* 400 million people are infected worldwide with CHC (that's 1 in every 15 people); 20 million have HIV
* 150,000 new cases of CHC are reported in the U.S.; compared to 40,000 for HIV
* 80 million people worldwide will die from CHC; compared to 20 million from HIV (that's four times as many deaths worldwide from CHC as from AIDS)
* Hepatitis C has been linked to increased mortality among persons with HIV


Hepatitis C can seriously damage the liver and affect its ability to function correctly. It is spread via the blood of an infected person, commonly through sharing needles. It can also be contracted through non-sterile tattoo or piercing equipment, pre-1991 blood transfusions (before blood was screened), unprotected sex and sharing razors or toothbrushes with a carrier.