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CATIE - www.catie.ca

Canadian HCV guidelines updated for 2015

March 12, 2015 - Hepatitis C virus (HCV) infects the liver and, if left untreated, eventually causes serious injury to this vital organ, leading to complications, liver failure and, in some cases, liver cancer. In the past year, combinations of new and powerful oral medications to treat HCV have been licensed in Canada. To help doctors, nurses and other healthcare professionals make decisions related to the care and treatment of HCV, leading liver and infectious disease physician-researchers in Canada have collaborated to update existing guidelines— An update on the management of chronic hepatitis C: 2015 Consensus guidelines from the Canadian Association for the Study of the Liver .

The update is rich in useful information about several aspects of HCV in Canada and is written in a style that is clear and easily understood by its target audience—doctors and other healthcare professionals who care for people with hepatitis C.

It is also timely because although new cases of HCV are declining, complications due to this infection are increasing because of an aging population whose liver injury is growing worse. In 2013, the costs of care (excluding anti-HCV drugs) for people with HCV were estimated at about $161 million. By 2032 these costs are expected to be at least $258 million.

To reduce the burden of future costs the team recommends that the offer of an HCV test be expanded across Canada. People who test positive can receive further assessment of their health as well as treatment. Increasing opportunities for HCV testing is important because research suggests that most people who have this virus are not aware that they are infected.

Assessing cure

The team of researchers states that the “primary objective of anti-HCV therapy is complete eradication [cure] of the virus.” The technical term for this used in HCV medicine is a “sustained virological response” (SVR). Traditionally, doctors defined SVR as 24 consecutive weeks of undetectable HCV RNA (viral load) after the cessation of a course of therapy. However, the researchers noted that emerging data from clinical trials of powerful new anti-HCV drugs suggest that a period of 12 weeks of undetectable HCV viral load after a course of treatment is “sufficient” to assess whether or not patients have been cured. The short form for this period is SVR 12. The researchers add that once SVR 12 is achieved it should be “considered a long-term cure of the virus because relapses are rare.” However, reinfection is possible so care must be taken to avoid future exposure to HCV.

The old regimen

For much of the past decade, treatment for HCV consisted of a long-acting form of interferon-alpha, called peginterferon, injected once weekly, and the broad-spectrum antiviral drug ribavirin taken orally twice daily. Peginterferon works by activating genes that help the immune system fight HCV. The duration of this treatment varied between 24 and 48 weeks. However, the rate of treatment success in clinics was sometimes less than 50%. Furthermore, peginterferon often caused side effects that were at best unpleasant—ranging from symptoms mimicking the flu to symptoms that affected mood, including irritability, difficulty falling asleep, anxiety and depression. What's more, ribavirin can temporarily reduce the amount of red blood cells, leading to extreme tiredness or lack of energy.

The new regimens

In the past year, powerful all-oral therapies have become licensed, particularly for genotype 1, which is the most common strain of HCV in Canada. Such therapies have been shown to be highly effective in clinical trials and well tolerated. Therefore, the researchers recommend the use of interferon-free combinations for HCV treatment, including the following:

  • Harvoni – a fixed-dose combination of sofosbuvir and ledipasvir
  • Holkira Pak – a combination of several drugs
  • simeprevir (Galexos) + sofosbuvir (Sovaldi)

Although the researchers made these recommendations, they note that not all Canadians will have access to these drugs in every region. That is because for many people infections such as HCV result in serious illness and are expensive to treat. Many provinces and territories have formularies—lists of drugs that they are willing to subsidize for people with catastrophic illnesses such as hepatitis C, cancer and HIV. However, it takes time for new drugs to be listed as the provinces and territories negotiate with pharmaceutical companies about the cost of new medicines.

Other strains

The researchers also reviewed clinical trial data and made recommendations for doctors who are caring for patients with less common genotypes of HCV. In some cases they suggest it may be possible to use interferon-free regimens.

Summary

The update to the Canadian guidelines is timely, useful and contains many recommendations that, if implemented, should result in improved care and treatment of HCV infection in Canada.

Resources

2015 Consensus guidelines from the Canadian Association for the Study of the Liver

CATIE's Hepatitis C information

Harvoni – CATIE fact sheet

Holkira Pak – CATIE fact sheet

Holkira Pak in clinical trials – TreatmentUpdate

—Sean R. Hosein

REFERENCE:

Myers RP, Shah H, Burak KW, et al. An update on the management of chronic hepatitis C: 2015 Consensus guidelines from the Canadian Association for the Study of the Liver. Canadian Journal of Gastroenterology & Hepatology . 2015 Jan-Feb;29(1):19-34.

From Canadian AIDS Treatment Information Exchange (CATIE). For more information visit CATIE's Information Network at http://www.catie.ca

Source: CATIE: CANADIAN AIDS TREATMENT INFORMATION EXCHANGE


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