Effectiveness of 8 weeks of ledipasvir/sofosbuvir for hepatitis C in HCV-HIV-coinfected patients.

BACKGROUND: Data is limited on the use of 8 weeks of therapy with Ledipasvir/Sofosbuvir (LDV/SOF) for special populations such as HCV/HIV-coinfected patients. The primary objective of this analysis was to compare SVR12 rates among HCV-monoinfected and HCV/HIV-coinfected patients in a real-world clinical setting. Additionally, we compared SVR12 rates among patients receiving 8 versus 12 weeks of therapy.

METHODS: This was a single-center, retrospective study of HCV-infected patients prescribed LDV/SOF at ambulatory clinics associated with the University of Maryland Medical Center (UMMC) from May 2015 to May 2016. Data were obtained from UMMC electronic medical record and outpatient pharmacy claims database. Comparisons between groups were made using Chi-squared or Fisher's exact test for categorical variables and Student's t-test or Wilcoxon rank-sum for continuous variables. All analyses were per-protocol; patients missing SVR12 data (25.2%) could not be evaluated for our stated objectives.

RESULTS: A total of 274 patients were included. Median age was 58 years; 62.8% were male; 82.5% were black. SVR12 data was available for 65 HCV/HIV-coinfected patients, of which 62 (95.4%) achieved SVR12. There was no difference in SVR12 rate between HCV/HIV-coinfected patients and HCV-monoinfected patients (86/90; 95.6%) (p = 0.959). Additionally, there was no difference in SVR12 attainment between HIV/HCV-coinfected patients who received 8 versus 12 weeks of therapy (p = 0.101).

CONCLUSIONS: Eight weeks of LDV/SOF was effective for treatment-naïve, non-cirrhotic, HCV-genotype 1 patients in this real-world setting, regardless of HIV status. Increased uptake of the 8-week regimen can decrease costs for patients and payers without compromising outcomes.