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New and Noteworthy
A new federal government study estimates that 138,600 Canadians have hepatitis C, but experts say the figures significantly play down the scale of the problem in Canada. The results are from the Canadian Health Measures Survey, which tested the blood of participants to look for the Hep B and C viruses. The study did not include Aboriginal people living on reserves, prisoners, members of the Armed Forces or people living in some remote regions.
“To get a good idea of the scale of the hepatitis B and C problems, the survey would need strong representation from certain population groups that typically don’t agree to take part in this kind of a study”, says Dr. Mel Krajden, a hepatitis C expert with the B.C. Centre for Disease Control.
Those groups include people who inject drugs, the homeless, Aboriginal people, prisoners and immigrants from parts of the world where hepatitis B and C infections are more common than they are in Canada.
While Dr. Krajden called the new data “a step in the right direction,” he believes the estimates in this new report are artificially low. (theglobeandmail.com, November 2013, in English)
The 2013 annual American Association for the Study of the Liver (AASLD) meeting ended with a debrief that summarized the vast amounts of Hep C clinical trial data that have been reported recently. Highlights of the debrief include:
Simeprevir (Olysio in U.S. and Galexos in Canada) or sofosbuvir in combination with peg-interferon and ribavirin are likely to become the new standard of care for hepatitis C in genotype 1 in the U.S. Cure rates are 80-90% and side effects are minimal with these combinations. All-oral, interferon-free regimens are also on the horizon.
Mid-stage trials of different sofosbuvir interferon-free combinations showed promising results for “difficult to treat” groups:
- people with genotype 1 with advanced liver damage (sofosbuvir, ledipasvir and GS 9669 or ribavirin),
- people with genotype 1 who did not respond to triple therapy with boceprevir or telaprevir (sofosbuvir and ledipasvir with and without ribavirin)
- people with genotype 3, an emerging harder to treat genotype (sofosbuvir and ribavirin for 24 weeks)
Researchers also presented promising data demonstrating cure rates in the 90%-100% percent range for all-oral combinations being developed by drug manufacturers. (HIVandhepatitis.com, November 2013, in English)
People who get Hep C again after being treated and getting a sustained virological response (SVR) or cure may be having a relapse of the initial infection rather becoming reinfected, reported researchers in the Journal of Infectious Diseases.
The researchers compared the Hep C genetic material, including the genotype or strain of the first Hep C virus infection with the second Hep C virus infection in three participants who got Hep C again after clearing the virus. The three participants tested positive for Hep C at 8 months, 75 months and 78 months post-SVR or cure. They found very high levels of similarity between the two viruses in each case, leading the researcher’s to suspect that the second infection may have been a relapse of the initial infection.
The researchers also found evidence that for these participants the liver may be acting as a reservoir for the Hep C virus. “Further studies are needed to elucidate how HCV RNA can be maintained at such low levels of virus for prolonged periods after SVR is achieved,” stated the researchers. (Healio.com, November 2013, in English)
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended compassionate access to daclatasvir in combination with sofosbuvir. The recommendation is for people who have genotype 1 who are at high risk of liver failure (decompensation) or who will die within 12 months if left untreated. The committee also recognized that this combination of medications may be beneficial for people with other genotypes.
The European Medicines Agency evaluates and approves new medicines for use in the European Union. Compassionate access programs give patients with a life-threatening, long-lasting or seriously disabling disease access to treatments that are still under development when no other treatments exist.
The CHMP has granted market authorisation to sofosbuvir (Sovaldi).
For more information on some of the clinical trials data of daclatasvir in combination with sofosbuvir, see TreatmentUpdate 198 Using daclatasvir and sofosbuvir when prior therapy fails (August 2013, in English and French)