New and Noteworthy
Application to Health Canada submitted for approval of AbbVie anti-hep C drug combination
AbbVie has filed a new drug submission to Health Canada for approval of a combination of drugs for adults with genotype 1 hepatitis C virus.
The treatment consists of:
- ombitasvir and ABT-450 boosted with ritonavir as a fixed dose, once daily
- dasabuvir, twice daily
- with or without ribavirin
The submission includes data from six late stage trials. (pharmaceuticalbusinessreview.com, May 2014, in English)
For more information about this combination, check out TreatmentUpdate 202.
Application to FDA for fixed dose combination of simeprevir (Galexos) and sofosbuvir (Sovaldi)
Janssen has submitted a supplemental drug application to the U.S. Federal Drug Administration (FDA) for the drug combination of simeprevir (Galexos) and sofosbuvir (Sovaldi) for adults with genotype 1 hepatitis C virus. For the mid-stage clinical trials on which the application was based, simeprevir (Galexos) and sofosbuvir (Sovaldi) were combined and tested as a single pill taken once daily with or without ribavirin for 12 or 24 weeks.
In ongoing late stage trials this fixed dose combination will be tested:
- For 8 or 12 weeks for people without cirrhosis who have never been treated or who are treatment experienced
- For 12 weeks for people with cirrhosis who have never been treated or who are treatment experienced
In the U.S. and Canada, both of these drugs are approved separately for use with peg-interferon and/or ribavirin, but they have not been officially approved for use together. However, some doctors may choose to prescribe these medications together off label. (Healio.com, May 2014, in English)
Methadone program participant’s willingness to take Hep C treatment linked to Hep C education
A study of participants in a New York City methadone program showed that having previously attended an education session about hepatitis C or expressing a willingness to go to a future session predicted willingness to receive Hep C treatment, reported researchers in the Journal of Addiction Medicine.
Participants who scored higher on Hep C related knowledge questions were also more likely to be willing to receive Hep C treatment. The study included 320 people, with almost half reporting that they had hepatitis C. The majority (78%) of participants were willing to be treated.
Based on these findings, the researchers conclude that methadone and other opiate substitution programs that have the infrastructure to support patient’s basic medical and educational needs could be appropriate settings for treating people with hepatitis C. (thebody.com, May 2014, in English)