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HCV Therapy for African-Americans
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Overall, African-Americans achieve 53-66% 4?3 rate SVR rate in the naive boceprevir & telaprevir studies. Treatment-Experienced AAs achieved similar SVR rates in the studies. Like whites AAs that achieved early responses, RGT[response-guided therapy], achieved 80-90% SVR rates. These AA SVR rates of 53-66% are double to triple the SVR rates from previous standard of care in naives, but of course with full adherence SVR rates increase for whites & blacks. If one was to place these terms in the Search Engine at the very top of the NATAP front page: African-Ameticans telaprevir, african-americans-boceprevir - they would receive many links including these few I am giving to you. The next wave of new oral HCV drugs is expected in about 1.5 to 2 years because there are 4 ongoing phase 3 studies which include a few new classes of HCV drugs and 2 additional protease inhibitors: a nucleotide GS-7977, an NS5A BMS-790052, a cyclophillin inhibitor alisporivir and the 2 proteases TMC435 & BI-201335. Our ability to combine these classes of drugs in one regimen are dependent on conducting drug interaction studies to see if we can combine them & how to do this in terms of do we need to adjust dosing. It is not expected that there will be an interaction between GS-7977 and protease inhibitors or with perhaps the other classes so that is hopeful. But we will soon know. The ultimate goal is interferon-free therapy and also ribavirin-free therapy, and studies show that at least for many patients we will be able to provide this but we need more studies to clearly understand for whom we can & perhaps cannot eliminate interferon & perhaps ribavirin. Personally & the feeling of many experts in the field is we will be able to eliminate interferon & ribavirin from therapy for most & perhaps all patients, but studies will examine this. One recent small study in whites who were prior null responders found a 100% cure rate with 2 oral drugs [BMS790052, a NS5A inhibitor, & BMS790032, a protease + peg/rbv]. Additional ongoing studies are now looking at the combination of 2 oral drugs, a protease plus the nucleotide mentioned above, with or without ribavirin in addition in treatment-naive patients & null responders, without interferon, so soon we will know results of these stuies. Over the course of the next 2 years we will learn a lot from ongoing studies that will help to answer all these questions. The ultimate goal is to be able to cure 100% of all patients & I think we can & will get there. Of course a person has to take medications & be adherent for them to work. The NATAP website is an excellent resource for this type of information, all the HCV studies and results are available on the site, plus lots of additional information on HCV and HIV as well. You can use the NATAP Search Engine at the very top of the front page to find any of the 30,000+ documents & reports on the website, by just inserting a key word or a few key words in the Search Engine space and all your results will pop up. Jules Levin, NATAP
· Telaprevir SVR & African-Americans, Latinos & Advanced Fibrosis
www.natap.org/2011/HIV/050411_01.htm
62% of African Americans/Blacks achieved SVR with telaprevir compared to 25% of African Americans/Blacks who were treated with pegylated-interferon and
· Telaprevir+pEg/RBV Based Combination Therapy in People with ...
www.natap.org/2010/AASLD/AASLD_04.htm
Nov 3, 2010 - ---62% of African Americans/Blacks in the ADVANCE study achieved a viral cure with telaprevir- ---Low discontinuation rates of all drugs due
· Boceprevir & Telaprevir SVR Rates Reported at FDA Hearing
www.natap.org/2011/HCV/050311_01.htm
Telaprevir study Demographics in ADVANCE naives: 7-11% Black/African-Americans; median age 49; (19-69); median BMI 26 kg/m2 (17-47); GT 1a: 58%
Telaprevir SVR rates in white & AAs, those with an early response (eRVR) 88% achieved SVR.
In this link is a simplified full review of all the boceprevir data in whites & blacks that has been on the website for a year::
Simplified Explanation of the Phase 3 Studies of HCV Protease Boceprevir...
www.natap.org/2011/HCV/032111_01.htm
Boceprevir is a HCV protease inhibitor for patients with genotype 1, the more ... HCV genotype 1 and included African Americans and people with advanced liver
Boceprevir
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