Safety and Efficacy of Ledipasvir/Sofosbuvir on Hepatitis C Eradication in HCV/ HIV Co-infected Patients

Introduction: There are few published data on the experience of FDA-approved oral combination of ledipasvir/sofosbuvir in HIV/HCV co-infected patients. The aim of this study is to evaluate the safety and efficacy of ledipasvir/sofosbuvir on hepatitis C eradication in patients with HCV and HIV co-infection in an urban HIV clinic center in Orlando.Figure: Demographic Characteristics of the Patients at Baseline.Figure: Antiviral regimen.Methods: A retrospective study was performed in patients co-infected with HIV-1 and HCV who were treated with the fixed-dose combination of ledipasvir and sofosbuvir for 12 weeks from 2014 to 2016. All patients included were receiving antiretroviral therapy (ART) with HIV RNA values of 100 copies/mL or fewer regardless of baseline HCV RNA level. The primary end point was a sustained virologic response at 12 weeks after the end of therapy.Figure: Response during and after Therapy.Results: Of the 40 patients enrolled, 55% were black, 22.5 % had been previously treated for HCV, and 25 % had cirrhosis. The patients were on a wide range of ART. Overall, 39 patients (97.5 %) had a sustained virologic response at 12 weeks after the end of therapy, including rates of 97.1% in patients with HCV genotype 1a and 100% in those with HCV genotype 1b.One patient with HCV genotype 3a was included and achieved SVR12 successfully. Rates of SVR12 were similar regardless of previous treatment or the presence of compensated cirrhosis. Only 1 patient experienced relapse at week 12 following treatment and deep sequencing didn't reveal any resistance associated mutation in the NS5A or NS5B region. Interestingly, 7(17.5%) patients who were adherent to ART experienced HIV viral breakthrough which resolved after continuing the same ART regimen. Two (5%) patients experienced HIV-1 virologic rebound due to noncompliance with HIV therapy, which resolved after resuming the same ART regimen. No severe adverse events were observed and no patient discontinued treatment because of adverse events. The most common adverse events included headache (12.5 %), fatigue (10%), and diarrhea (2.5%). Conclusion: This retrospective study demonstrated the high rates of SVR12 of ledipasvir/sofosbuvir on HCV eradication in patients co-infected with HCV and HIV, regardless of HCV baseline levels, HCV treatment history or cirrhosis condition. The oral combination of ledipasvir/sofosbuvir represents a safe and well-tolerated HCV treatment option that does not require modification for many of the common HIV ART. HIV virologic rebound during the treatment emphasized the importance of closely monitoring HIV RNA level while treating HCV.