Real-world Effectiveness of Ledipasvir/Sofosbuvir (LDV/SOF) for 8 weeks in Patients Coinfected with HCV and HIV-1

• Published in: Open forum infectious diseases 2017-10, Vol.4 (suppl_1), p.S658-S658
• Main Authors: Ruane, Peter, Buggisch, Peter, Moreno, ANA, Isakov, Vasily, Backus, Lisa, Ain, Dani, Gonzalez-Garcia, Juan, Naik, Sarjita, Mehta, Swarup, Lee, Jina, Llewellyn, Joe, Mertens, Michael, Natha, Macky, Osinusi, Anu, Slim, Jihad, Zhdanov, Konstantin, Berenguer, Juan, Zeuzem, Stefan
• Format: Article
• Language: English
• Subjects: Abstracts
• ISSN: 2328-8957; 2328-8957
• DOI: 10.1093/ofid/ofx163.1752

Abstract Background Real world cohorts (RWC) have demonstrated excellent efficacy of LDV/SOF for 8 weeks in HCV monoinfected patients. Real world effectiveness data of LDV/SOF for 8 weeks in HIV/HCV coinfection is emerging from several multiple single-center and multicenter prospective and retrospective cohorts. The aim of this study was to describe the effectiveness of the single tablet regimen of LDV/SOF for 8 weeks in HCV genotype (GT) 1 patients with HIV/HCV coinfection in RWC. Methods In this descriptive analysis, data from two prospective studies, one investigator sponsored and 1 registrational trial, one prospective RWC, three retrospective RWC of LDV/SOF for 8 weeks in HIV/HCV co-infected patients were compared. RWC were selected based on willingness to participate and had at least 15 HIV/HCV co-infected patients. The prospective trials include data from Ain et al (investigator sponsored) and Isakov et al (registrational trial). The RWC include the Deutsches Hepatitis C-Register, Madrid Coinfection Registry (Madrid-CoRe),Veterans Affairs HCV Registry, and Slim et al, representing diverse patient populations from Europe and US. Baseline characteristics and efficacy were analyzed. Results The majority of the 294 patients included in this descriptive analysis were GT 1, treatment naïve (TN), noncirrhotic (NC), and had a HCV viral load < 6 million. The prospective cohorts enrolled 79 patients with the following baseline characteristics: mean age (43 years), male (66%), white (89%), and GT 1a (41%). The RWC studies assessed enrolled 215 patients with the following overall baseline characteristics: mean age (54 years) male (84%), white (82%), and GT 1a (75%) in those that reported demographics. The overall SVR12 from six diverse real world and post-marketing cohorts was 94% (277/294). The individual study results are presented in Table 1. Conclusion This analysis of diverse cohorts from the EU and US yielded high SVR rates similar to SVR rates seen in multiple RW monoinfected cohorts and supports the use of 8 weeks of LDV/SOF in TN, NC GT 1 HIV/HCV coinfected patients with a baseline HCV viral load < 6 million. Disclosures P. Ruane, Gilead: Investigator, Scientific Advisor and Shareholder, Consulting fee and Research support; Merck: Speaker’s Bureau, Speaker honorarium; Boehringer: Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research support and Speaker honorarium; Janssen: Investigator, Scientific Advisor and Speaker’s Bureau,