Assessing the Safety of Direct-Acting Antiviral Agents for Hepatitis C

Abstract

Key Points Question Are patients with hepatitis C who receive direct-acting antivirals at increased risk for adverse events compared with those who do not receive these agents? Findings In this cohort study of 33 808 patients in 3 health systems, direct-acting antiviral exposure was associated with lower odds of experiencing the following adverse events: death, multiple organ failure, hepatic decompensation, acute-on-chronic liver event, and arrhythmia. Meaning Concerns about safety risks based on analyses of the US Food and Drug Administration’s Adverse Events Reporting System did not appear to be confirmed, suggesting that dispensed direct-acting antivirals may be safe for patients with hepatitis C.

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

“…Several well-designed, robust clinical trials have demonstrated the safety (147) and high curative efficacy of glecaprevir/pibrentasvir (148)(149)(150)(151)(152)(153)(154)(155)(156)(157)(158) and sofosbuvir/ velpatasvir (159)(160)(161)(162)(163)(164) among treatment-naive persons without cirrhosis regardless of HCV genotype. These findings have been confirmed in real-world cohort studies for both glecaprevir/pibrentasvir (165)(166)(167) and sofosbuvir/velpatasvir.…”

Pre-transplant Sarcopenic Obesity Worsens the Survival After Liver Transplantation: A Meta-Analysis and a Systematic Review

“…Despite the rising prevalence of SO among LT patients, especially in the subgroup of NASH ( 11 ), the optimal management of obese and overweight LT candidates remained undetermined. Increased body mass index is commonly observed after LT ( 30 ), and it appears that much of this weight gain is an increase in fat mass ( 31 ).…”

“…More than 32% of the US population is considered to be obese, based on the body mass index (BMI) cut-off of 30 kg/m 2 ( 9 , 10 ). It is common knowledge that obesity increases the risk of perioperative complications ( 11 ) but how it affects the outcomes of LT in the long-term remains unclear. Studies have demonstrated that sarcopenia is an independent predictor of mortality, sepsis, and a more extended hospital stay after living donor LT ( 12 – 14 ).…”

Current international guidelines for the management of patients with chronic viral hepatitis C

“…Несколько хорошо спланированных и надежных клинических испытаний продемонстрировали безопасность [16] и высокую лечебную эффективность схемы глекапревир/пибрентасвир и комбинации софосбувир/велпатасвир среди наивных лиц без цирроза, независимо от генотипа ВГС [17][18][19][20][21]. Эти данные были подтверждены в реальных когортных исследованиях как для схемы глекапревир/пибрентасвир, так и для комбинации софосбувир/велпатасвир [22][23][24].…”