This is the last of the AASLD 2014 conference coverage (I promise!), but there was one more study I thought was important to discuss.
The Safety and Efficacy of Ledipasvir and Sofosbuvir in African Americans: A Retrospective Analysis of Phase 3 Data – L Jeffers et al.
The information from the Phase 3 studies of ledipasvir plus sofosbuvir, and of ledipasvir, sofosbuvir plus ribavirin, was compiled, and the information about the African American patients was extracted. The treatment durations in these studies were 8, 12 or 24 weeks. The patient characteristics of the African American were generally older, higher Body Mass Index, more likely to have IL28B non-CC (a variation that is less likely to respond to treatment) and lower ALT (liver enzyme levels).
The information from the Phase 3 studies of ledipasvir plus sofosbuvir, and of ledipasvir, sofosbuvir plus ribavirin, was compiled, and the information about the African American patients was extracted. The treatment durations in these studies were 8, 12 or 24 weeks. The patient characteristics of the African American were generally older, higher Body Mass Index, more likely to have IL28B non-CC (a variation that is less likely to respond to treatment) and lower ALT (liver enzyme levels).
The combined results from all of the phase 3 studies showed the overall cure rates among African Americans to be similar to the non-Blacks in the study groups. The authors did note that “Although high SVR rates were observed, the limited number of black patients with cirrhosis precludes definitive conclusions in this subpopulation.” In other words it would be hard to draw conclusions regarding effectiveness of the drugs when comparing African Americans and the other groups because there were so few African Americans in the study who had cirrhosis.
Comments: When interferon-based therapy was the standard of care to treat hepatitis C, African Americans had much lower cure rates compared to most other races. Now that the standard of care is interferon-free therapies, African American cure rates are the same as the cure rates seen in other races. Many old ‘facts’ die hard; so let’s put this one to rest and get the message out that that African Americans respond just as well to interferon-free therapies as other populations.
This was a presentation that was posted to NATAP courtesy of Jules Levin.
http://hcvadvocate.org/news/newsLetter/2015/advocate0115_mid.html#2
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