Hepatitis C

WHO issues first guidance for hepatitis C treatment

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The World Health Organisation (WHO) has issued its first guidance for the treatment of hepatitis C, a chronic infection that affects an estimated 130 million to 150 million people and results in 350 000 to 500 000 deaths a year.

The publication of the “WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection” coincides with the availability of more effective and safer oral hepatitis medicines, along with the promise of even more new medicines in the next few years.

“The WHO recommendations are based on a thorough review of the best and latest scientific evidence,” says Dr Stefan Wiktor, who leads WHO’s Global Hepatitis Programme. “The new guidance aims to help countries to improve treatment and care for hepatitis and thereby reduce deaths from liver cancer and cirrhosis.”

WHO will be working with countries to introduce the guidelines as part of their national treatment programmes. WHO support will include assistance to make the new treatments available and consideration of all possible avenues to make them affordable for all. WHO will also assess the quality of hepatitis laboratory tests and generic forms of hepatitis medicines.

“Hepatitis C treatment is currently unaffordable to most patients in need. The challenge now is to ensure that everyone who needs these drugs can access them,” says Dr Peter Beyer, Senior Advisor for the Essential Medicines and Health Products Department at WHO. “Experience has shown that a multi-pronged strategy is required to improve access to treatment, including creating demand for treatment. The development of WHO guidelines is a key step in this process.”

The new guidelines make nine key recommendations. These include approaches to increase the number of people screened for hepatitis C infection, advice as to how to mitigate liver damage for those who are infected and how to select and provide appropriate treatments for chronic hepatitis C infection.

WHO recommends a screening test for those considered at high risk of infection, followed by another test for those who screen positive, to establish whether they have chronic hepatitis C infection.

Since alcohol use can accelerate liver damage caused by hepatitis C, WHO now advises that people with chronic hepatitis C infection receive an alcohol assessment. The Organization also recommends providing counselling to reduce alcohol intake for people with moderate or high alcohol use. In addition, the guidelines provide advice on the selection of the most appropriate test to assess the degree of liver damage in those with chronic hepatitis C infection.

The guidelines provide recommendations on existing treatments based on interferon injections as well as the new regimens that use only oral medicines. WHO will update recommendations on drug treatments periodically as additional antiviral medicines are registered on the market and new evidence emerges.

The 2014 recommendations also summarize for policy makers and health care workers interventions that should be put in place to prevent transmission of hepatitis C, including measures to assure the safety of medical procedures and injections in health care settings and among persons who inject drugs. Rates of new hepatitis C infections remain unacceptably high in many countries because of the reuse of injection equipment and lack of screening of blood transfusions.

“Many people remain unaware – sometimes for decades – that they are infected with hepatitis C,” says Dr Andrew Ball, Senior Advisor for Policy, Strategy and Equity for WHO’s HIV/AIDS Department where the Global Hepatitis Programme is housed. “Today’s launch highlights the need for more awareness and education on hepatitis for the general public. Greater awareness on the risks associated with hepatitis C should lead to a demand for services and expansion of laboratory capacity and clinical services so that more people can be tested, treated and cured.”

There are five main hepatitis viruses, referred to as types A, B, C, D and E. Hepatitis B and C have the greatest public health impact because they cause chronic infection which can progress to cirrhosis and liver cancer. Hepatitis A and E, spread though unsafe water and contaminated food, have the potential to cause outbreaks in certain populations.

Hepatitis C virus is most commonly transmitted through exposure to contaminated blood. Those at risk include people undergoing invasive medical procedures and therapeutic injections where there is poor infection control. Also at risk are those exposed to contaminated injecting and skin piercing equipment, including through injecting drug use, tattooing and body piercing.

The WHO Guidelines for the screening, care and treatment of persons with hepatitis C infection were launched on the eve of the opening of the 2014 International Liver Congress, attended by around 10 000 delegates in London.

Source: PharmaBiz

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FDA approves first genotyping test for patients with hepatitis C virus

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The U.S. Food and Drug Administration today approved a test that identifies the genotypeof hepatitis C virus (HCV) that apatientis carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient’s blood plasma or serum, will aid health care professionals in determining the appropriate approach to treatment.   Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.
“Tests such as this one can help physicians gain an understanding of a patient’s HCV status,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Along with other clinical factors, the particular type of HCV is an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment.”
According to the Centers for Disease Control and Prevention, HCV is the most common chronic blood-borne infection in the United States and the leading cause of liver transplants. About 3.2 million people in the United States have a chronic HCV infection and approximately 15,000 people die from the effects of the virus each year. Seventy-five to 85 percent of people infected with HCV are not able to fight off the virus on their own and develop a chronic HCV infection that requires treatment. Untreated chronic HCV infections may lead to liver cancer, severe liver damage and liver failure.
HCV is transmitted through blood and other bodily fluids. Injection drug users who share needles are at the highest risk for HCV infection. Health care workers stuck by needles that have been used on HCV-infected patients and children born to HCV-infected mothers are also at risk.
hep c
The Abbott RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV. It is not approved for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products or tissue donors. It has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with AIDS.
The FDA based its approval of the Abbott RealTime HCV Genotype II, in part, on the assessment of the test’s accuracy in differentiating specific HCV viral genotypes compared to a validated genesequencing method.  The FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy.
The Abbott RealTime HCV Genotype II test is manufactured by Abbott Molecular Inc.,
in Des Plaines, Ill.

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