Ledipasvir/Sofosbuvir Is Safe and Effective for the Treatment of Patients With Genotype 1 Chronic HCV Infection in Both HCV Mono-and HCV/HIV Co-Infected Patients
Year: 2015
Type: article
Abstract: Background. The current AASLD/IDSA Hepatitis C Guidance states that HIV/HCV-coinfected persons should be treated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications. We compared the safety and efficacy of the single tablet regimen of ledipasvir/sofosbuvir (LDV/SOF) in HCV genotype (GT) 1 patients co-infected with HIV-1 in the Phase III ION-4 study with HCV mono-infected GT 1 patients in the Phase III ION 1-3 studies. Methods. In the ION-4 study, 327 GT 1 HCV/HIV co-infected patients (126 treatment-naive, non-cirrhotic, 134 treatment-experienced, non-cirrhotic, 20 treatment-naive, cirrhotic, 47 treatment-experienced cirrhotic) received LDV/SOF 90/400 mg daily for 12 weeks. In the ION 1-3 studies, 538 GT 1 HCV mono-infected patients (395 treatment-naive, non-cirrhotic, 87 treatment-experienced, non-cirrhotic, 34 treatment-naive, cirrhotic, 22 treatment-experienced cirrhotic) received LDV/SOF 90/400 mg daily for 12 weeks. This pooled analysis will assess safety and sustained virologic response at week 12 (SVR12). Results. Overall, 865 patients were treated with 12 weeks of LDV/SOF in the Phase III ION program. In ION 1-3, the majority of patients were male (329, 61%), nonblack (449, 83%), and treatment-naive (430, 80%). 56 (10%) patients had cirrhosis. In ION-4, the majority of patients were male (276, 82%), nonblack (220, 66%), and treatment-experienced (185, 55%). 67 (20%) patients had cirrhosis. SVR12 and relapse data are reported in the table. Treatment was well tolerated in both mono-infected and co-infected patients. Most common adverse events (>10% reported in any arm) were fatigue, headache, diarrhea, and nausea. Only two patients discontinued treatment due to an adverse event. Conclusion. In this pooled analysis, the once daily, single tablet regimen of LDV/SOF for 12 weeks provided high rates of SVR regardless of presence of HIV infection and is a safe, well-tolerated option for patients with both HCV mono-infection and HIV/HCV co-infection. Disclosures. S. Naggie, AbbVie: Consultant and Investigator, Consulting fee and Research grant. Achillion: Consultant and Investigator, Consulting fee and Research grant. BMS: Investigator, Research grant. Gilead Sciences: Consultant and Investigator, Consulting fee and Research grant. Vertex: Investigator, Research grant. Janssen: Investigator, Research grant. Merck: Consultant and Investigator, Consulting fee and Research grant. IAS-USA: Educational Activities for this company generates revenue for Duke, Revenue generated for Duke. IDSA: Consultant, Consulting fee; C. Cooper, Gilead Sciences: Consultant, Investigator and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium. AbbVie: Consultant, Investigator and Speaker's Bureau, Consulting fee, Research support and Speaker honorarium. Merck: Consultant and Investigator, Consulting fee and Research support. BMS: Consultant, Consulting fee. Roche: Investigator, Research support; P. Kwo, AbbVie: Investigator and Scientific Advisor, Consulting fee and Research grant. BMS: Investigator and Scientific Advisor, Consulting fee and Research grant. Gilead Sciences: Investigator and Scientific Advisor, Consulting fee and Research grant. Janssen: Investigator and Scientific Advisor, Consulting fee and Research grant. Merck: Investigator and Scientific Advisor, Consulting fee and Research grant; K. Kowdley, Evidera: Consultant, Investigator and Scientific Advisor, Consulting fee and Research grant. Gilead Sciences: Consultant, Investigator and Scientific Advisor, Consulting fee and Research grant. Immuron: Investigator, Research support Intercept: Investigator, Research support. Tobira: Investigator, Research grant AbbVie: Consultant and Scientific Advisor, Consulting fee. Achillion: Consultant and Scientific Advisor, Consulting fee. BMS: Consultant and Scientific Advisor, Consulting fee. Merck: Consultant and Scientific Advisor, Consulting fee. Novartis: Consultant and Scientific Advisor, Consulting fee. Trio Health: Consultant and Scientific Advisor, Consulting fee. Up-To-Date: Collaborator, Licensing agreement or royalty Annals of Hepatology: Editorial Board, None; S. Naik, Gilead Sciences: Employee, Salary; M. Natha, Gilead Sciences: Employee, Salary; L. Stamm, Gilead Sciences: Employee, Salary; P. S. Pang, Gilead Sciences, Inc: Employee, Salary
Source: Open Forum Infectious Diseases
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,053
OpenAlex ID: W2318705609