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HIV/HCV Coinfected and HCV Monoinfected Patients Have Similar Early Hepatitis C Viral Kinetics with the Potent HCV Nucleotide Polymerase Inhibitor Sofosbuvir (SOF)
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Reported by Jules Levin
ICAAC, 12 September 2012, San Francisco, CA
Maribel Rodriguez-Torres1, Milagros Gonzales1,
Jorge Rodriguez1, Stephen Rossi2, Gong Shen2,
Anita Mathias2, Bill Symonds2
1Fundacion de Investigacion de Diego, San Juan, PR
2Gilead Sciences, Inc., Foster City, CA
Program Abstract
Background: HIV/HCV co-infected pts have more rapid progression of liver disease and a poor response to current HCV therapies. SOF is a potent, pan-genotypic, once-daily (QD) nucleotide in late-stage development in HCV mono-infected pts. Methods: A Phase 1b study was conducted in HCV treatment-naive pts with HIV/HCV co-infection to evaluate HCV antiviral activity, safety, and drug interactions with HIV antiretrovirals (ARVs) with SOF 400 mg QD for 7 days. Patient characteristics and viral kinetics were compared with results from two prior HCV mono-infection cohorts in HCV genotype (GT) 1 and GT 2/3 patients. Results: Nineteen patients were enrolled on a stable ARV regimen, undetectable HIV RNA, and CD4 >350 cells/mm3. Median change in HCV RNA was similar to monoinfected pts, with >1.5 log10 reductions at 24 hours and a maximal HCV RNA decline from baseline > 4 log10. Virologic response was similar in the coinfected and monoinfected cohorts independent of HIV status, HCV genotype and baseline HCV viral load. SOF was well tolerated with no new safety events were observed during the dosing or safety follow-up period. No effect was observed on HIV viral load, CD4 count, or CD4%. Conclusions: Comparable HCV early viral kinetics was observed in HIV/HCV and HCV infected patients and support further study of SOF in HIV/HCV co-infected pts.
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