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Combination Oral, Hepatitis C Antiviral Therapy for 6 or 12 Weeks:
Results of the SYNERGY Trial
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Reported by Jules Levin
CROI 2014 March 3-6 Boston, MA
Anita Kohli, Zayani Sims, Miriam Marti, Amy Nelson, Anu Osinusi, Dimitra Bon, Eva Hermann, Colleen Kotb, Rachel Silk, Gebeyehu Teferi, William T. Symonds, Phil S Pang, John McHutchison, G. Mani Subramanian, Michael A. Polis, Henry Masur, Shyam Kottilil
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Department of Health and Human Services
Bethesda, MD
CROI webcast:
http://www.croiwebcasts.org/console/player/22172?mediaType=slideVideo&
"In summary 39 of 40 patients who are part of this historically very difficult to treat population achived SVR 12 after being treated for 6 weeks with combination DAA therapy
All patients on Arm A achieved SVR 24, and 12/12 on Arm B have achieved SVR24"
"We looked at early viral kinetics to evaluate if addition of a third DAA would be able to enhance viral clearance and could aid in developing a model that can predicting combinations which may efficacious in shorter period of time
As you can see (green line)
Fitted HCV RNA was significantly lower at early time points in patients treated with sofosbuvir, ledipasvir and GS-9451 compared to the two other regimens (p<0.05) HCV RNA at days 7, 14 and 21
· Eleven Grade 3 lab abnormalities in nine patients
· Baseline gradeable elevated creatinine
· No Grade 4 events
· ALT/AST elevation in patient eating multiple grapefruit and taking lurasidone
· Glucose abnormalities in patient with IDDM
· Transient anemia in patient with history of anemia- no intervention required
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