Safety and Efficacy of Sofosbuvir/Velpatasvir for the Treatment of Chronic Hepatitis C in Patients Aged 65 Years or Older: A Retrospective Analysis of Phase 3 Studies

Shiffman, Mitchell L.; Sulkowski, Mark S.; Foster, Graham; Byrne, Sean; Wolf, John; Grabowski, Chester; McNally, John; Brainard, Diana M.; Etzkorn, K. Peter; Sheikh, Aasim; Feld, Jordan J.

doi:10.1016/s0016-5085(17)33695-8

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“…Shiffman and colleagues reported outcomes of 123 patients aged 65 years or older enrolled in three phase 3 studies who received sofosbuvir/velpatasvir, a pan-genotypic DAA, for 12 weeks for the treatment of chronic HCV [ 29 ]. Fourteen of the patients were ≥ 75 years old.…”

Section: Evidence From Phase 2 and Phase 3 Clinical Trialsmentioning

confidence: 99%

Hepatitis C Virus in the Elderly in the Direct-Acting Antiviral Era: from Diagnosis to Cure

Abdul

Snyder

Chunduru

et al. 2020

Curr Treat Options Infect Dis

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Purpose of review Hepatitis C (HCV) is the most common cause of viral hepatitis in elderly individuals. This patient population previously experienced suboptimal outcomes with interferon-based regimens. Unfortunately, patients aged 65 years and older were underrepresented in phase 2 and 3 clinical trials with newer direct acting antiviral (DAA) therapies. Since the advent of second-generation DAA in 2013, numerous robust real-world experiences highlighting the efficacy and safety of DAA in the elderly have been published. This review article summarizes the cascade of care for hepatitis C from diagnosis to cure from an evidence-based perspective of the aging population. Recent finding In a large study from the Veterans Affairs Healthcare System, the overall sustained virologic response (SVR) of 15,884 patients treated with DAA regimens was 91.2%. These newer therapies remained highly effective in the subset of patients aged 65 years and older with SVR rates above 90%. A Spanish National Registry reported outcomes in patients ≥ 65 years old treated for HCV with oral DAA regimens over a 2-year period. The overall SVR was 94% in the study of 1252 subjects. Summary Current real-world data imply DAA treatment regimens remain highly effective and safe in elderly patients when compared to the general population.

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Section: Evidence From Phase 2 and Phase 3 Clinical Trialsmentioning

confidence: 99%