Presentation Abstract

Session: 238-Common Pathogens: Still a Problem in HIV-I
Wednesday, Sep 12, 2012, 9:15 AM -11:45 AM
Presentation Title: H-1921a - HIV/HCV Coinfected and HCV Monoinfected Patients Have Similar Early HCV Viral Kinetics with the Potent HCV Nucleotide Polymerase Inhibitor Sofosbuvir (SOF)
Location: Room 102
Presentation Number: H-1921a
Pres. Time: Wednesday, Sep 12, 2012, 10:45 AM -11:00 AM
Category: H3
Keywords: hcv; coinfection; antiviral
Author(s): M. Rodriguez-Torres, MD - Principle Investigator 1, M. Gonzales, MD - Investigator 1, J. Rodriguez, PhD - Investigator 1, S. Rossi, PharmD - Sr Director, Clinical Research2, G. Shen, PhD - Manager, Biostatistics 2, A. Mathias, PhD - Director, Clinical Pharmacology 2, B. Symonds, PharmD - Vice President, Clinical Research 2;
1Fundacion de Investigacion de Diego, San Juan, PR, 2Gilead Sci., Foster City, CA.
Financial Disclosures:  M. Rodriguez-Torres,
Gilead Sciences Role(s): Investigator, Research Contractor, Research Relationship, Scientific Advisor (Review Panel or Advisory Committee).
M. Gonzales,
Gilead Sciences Role(s): Investigator, Research Contractor.
J. Rodriguez,
Gilead Sciences Role(s): Investigator, Research Contractor.
S. Rossi,
Gilead Sciences Role(s): Employee, Shareholder (excluding diversitied mutual funds).
G. Shen,
Gilead Sciences Role(s): Employee, Shareholder (excluding diversitied mutual funds).
A. Mathias,
Gilead Sciences Role(s): Employee, Shareholder (excluding diversitied mutual funds).
B. Symonds,
Gilead Sciences Role(s): Employee, Shareholder (excluding diversitied mutual funds).
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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