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New and noteworthy
Holkira Pak (AbbVie 3D combination) approved by Health Canada
Holkira Pak cures Hep C in most liver transplant recipients
Birth cohort screening more effective than risk-based testing in U.S.
Holkira Pak (AbbVie 3D combination) approved by Health Canada
In December 2014, Health Canada approved the hepatitis C medication combination Holkira Pak (dasabuvir + ombitasvir/paritaprevir/ritonavir) for people over the age of 18 with genotype 1 hepatitis C virus. In clinical trials, the cure rate for this combination was 92% to 100%.
Holkira Pak is a combination of three direct-acting anti-virals (DAAs). DAAs attack the ability of a virus to make copies of itself.
• paritaprevir, a protease inhibitor, which is boosted with ritonavir
• ombitasvir, an NS5A inhibitor
• dasabuvir, a NS5B inhibitor
Paritaprevir/ritonavir and ombitasvir are co-formulated into one tablet. Dasabuvir is its own tablet. Some people take this combination with ribavirin.
The majority of people take Holkira Pak for 12 weeks. People with genotype 1a virus who have cirrhosis and who have been previously treated with peg-interferon and ribavirin but did not have any response to treatment (prior null responders) are recommended to take Holkira Pak and ribavirin for 24 weeks. (prnewswire.com, December 2014, in English)
Holkira Pak cures Hep C in most liver transplant recipients
97% of liver transplant recipients treated with Holkira Pak and ribavirin for 24 weeks were cured in a mid-stage trial, reported researchers at the American Association for the Study of Liver Diseases (AASLD) 2014 Meeting in Boston.
Hepatitis C recurs in people who have the virus after they have a liver transplant, so treatment is still necessary after the transplant.
The clinical trial included 34 participants. The majority of the participants were white, male and with an average age of 60. All participants had mild or moderate liver damage (fibrosis).
This treatment was generally well tolerated. The most common side effects were fatigue, headache, cough, anemia, diarrhea, insomnia, weakness and nausea.
According to the researchers, “This phase 2 study in liver transplant recipients with mild to moderate liver disease shows that antiviral therapy may offer clinical benefit before the acceleration of fibrosis to advanced liver disease and its associated complications in this patient population.” (HIVandhepatitis.com, December 2014, in English)
Birth cohort screening more effective than risk-based testing in U.S.
Age cohort screening for hepatitis C identified four times as many people as current screening protocols, reported researchers at the American Association for the Study of Liver Diseases (AASLD) 2014 Meeting in Boston.
Studies have shown that people born between 1945 and 1965 (also known as baby boomers) in the U.S. have a substantially higher hepatitis C prevalence than the U.S. general population.
Between 2012 and 2014, the Center for Disease Control and Prevention (CDC) conducted three large randomized trials comparing birth cohort screening for baby boomers and usual care. Participants in the study were born between 1945 and 1965 and did not have a record of being tested for hepatitis C.
In the first trial, a random sample of participants received repeated mailings inviting them to go the nearest lab for testing.
In the second trial, medical assistants or clinicians were alerted to offer hepatitis C testing to people in the targeted age group.
In the third trial, participants were offered hepatitis C testing by a recruiter in the waiting room.
Each trial had a comparison group that received the usual care.
The intervention in the first trial was eight times more likely to identify people with hepatitis C than the usual care. In the second trial, the intervention identified just over three times the number of people with hepatitis C as usual care. In the third trial, 31% of people in the birth cohort were tested compared to 4% of participants who received the usual care.
“Overall, HCV testing of persons born during 1945–1965 without prior ascertainment of HCV risk was 4 times more effective in identifying persons with previous or current HCV infection compared with usual care,” the researchers concluded. (HIVandhepatitis.com, December 2014, in English)