Real world effectiveness of 8 vs 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) in blacks with HCV: A comparative analysis of clinical trials with real world cohorts.

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BACKGROUND: Black patients have among the highest rates of chronic Hepatitis C Virus (HCV) infections compared to other racial groups in the United States (U. S. ). In the past, Blacks had lower cure rates with interferon‐based regimens for HCV treatment compared to Whites. In the Direct Acting Antiviral (DAA) era, recent published reports suggest Black patients achieve similar Sustained Virologic Response (SVR) rates with SOF‐based regimens in Real World Cohorts (RWC) as those observed in clinical trials including those who treated for 8 weeks. The aim of this analysis was to compare the efficacy of the single tablet regimen of ledipasvir/sofosbuvir (LDV/SOF) in HCV genotype 1 Black patients in clinical trials to that observed in RWC. METHODS: In this descriptive analysis, data from the Phase 3 ION trials evaluating LDV/SOF is compared to five RWC. RWC were selected based on availability of data, non‐overlapping data sets, and treatment of at least 50 patients. The RWC include ASCEND, Burman's Specialty Pharmacy/Temple University, and Department of Veterans Affairs (VA) (Baltimore, Cleveland, and National) and represent diverse patient populations from the U. S. including academic centers, urban primary care settings and the VA. Baseline characteristics and efficacy were analyzed. RESULTS: Of the 1079 patients treated in the ION 1, 2, and 3 trials, 308 were Black (16%) with the following baseline demographics: mean age (57 years), male (65%), GT 1a (70%), and treatment naïve (TN) (75%). Among Black patients that were treatment naïve, non‐cirrhotic, viral load < 6 million and were treated for 8 or 12 weeks of LDV/SOF, they had an overall SVR12 rate of 96% (26/27) and 98% (59/60), respectively. In the RWC, the proportion of Blacks in each cohort was as follows: ASCEND: 96% (576/600); Burman's Specialty Pharmacy/Temple University: 31% (104/338); Department of Veterans Affairs: Baltimore: 79% (539/687); Cleveland: 62% (206/331); and National: 41% (4871/11804). Baseline characteristics reported from the overall RWC cohort was as follows: mean age (60 years), male (82%), GT 1a (77%), and TN (89%). In the RWC, among Black patients treated with 8 or 12 weeks of LDV/SOF, the overall SVR12 was 93% (1449/1563) and 94% (1575/1668), respectively. CONCLUSIONS: This analysis of diverse cohorts from the U S comparing the effectiveness of both 8 and 12 weeks of LDV/SOF have demonstrated comparable SVR rates in Black patients in RWC These results support the use of 8 weeks of LDV/SOF in Black treatment naive, non‐cirrhotic GT 1 patients with a baseline HCV viral load < 6 million.



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