Adverse effects of direct acting antiviral-based regimens in chronic hepatitis C patients: a Brazilian experience

Abstract

Background Direct-acting antivirals (DAA) are currently used for the treatment of chronic hepatitis C (HCV). However, few studies describe the adverse effects (AE) associated with DAA therapy in "real-word" cohorts. Aim To evaluate AE in Brazilian chronic HCV patients after DAA-therapy. Setting A reference center for hepatitis treatment in Rio de Janeiro, Brazil. Methods An observational "real-world" study was conducted with 102 chronic HCV patients undergoing DAA therapy for 12 or 24 weeks. The self-reported AE were correlated with cirrhosis status, genotype, age, current therapeutic schemes and comorbidities. Serious AE were also investigated. Main outcome measure Frequency of AE during DAA therapy. Results Overall, mean ± SD age was 60.9 ± 9.4 years, 67% were females, HCV-genotype 1 was the most prevalent (81%) and 74% were cirrhotic. Moreover, all patients reached sustained virological response. About 90% of patients reported at least one AE associated with current treatment, with a mean of 2.7 symptoms per patient. The most frequently reported AE were fatigue (43%), headache (42%), neuropsychiatric symptoms (30%) and nausea (26%). Furthermore, hemoglobin < 12 mg/dL was the most frequent (38%) laboratory abnormality observed. Neuropsychiatric symptoms were the only AE significantly different in treatment-experienced group when compared to naïve patients (41.7 vs. 12.5, P = 0.002). The higher frequency of AE did not correlate with the presence of previous treatment, cirrhosis, genotype, age, current therapeutic schemes with DAA or comorbidities. Conclusion DAA-based therapeutic regimens demonstrated safety in a Brazilian "real-world" cohort of chronic hepatitis C patients.

Renal safety after one year of sofosbuvir‐based therapy for chronic hepatitis C: A Brazilian “real‐life” study

“…Besides, a previous study from our group described that one patient had SOF therapy discontinued due to hepatorenal syndrome. 17 Concerning the laboratory evaluation before and after treatment, we observed an improvement in hepatic parameters in both groups, as demonstrated by reduction in serum levels of ALT, AST, GGT and ALP, besides an increase in serum levels of albumin (Appendix S1).…”

“…The analysis of clinical data from patient's records showed that three patients (3.2%) from the GFR <45 mL/min/1.73 m 2 group had SOF daily doses adjusted due to an increase in Cr serum levels, and one patient (1.1%) had the treatment period reduced from 24 to 12 weeks for the same reason. Besides, a previous study from our group described that one patient had SOF therapy discontinued due to hepatorenal syndrome …”

Predictors of adverse drug reactions associated with ribavirin in direct‐acting antiviral therapies for chronic hepatitis C

“…[9][10][11] However, few studies have been conducted in Brazil evaluating the safety of direct-acting antivirals. 12,13 Thus this study aimed to identify factors associated with the development of adverse drug reactions (ADRs) to new direct-acting antiviral agents for hepatitis C treatment associated or not to ribavirin at three centers in the Brazilian public health system.…”

Sustained Virologic Response Rate in Chronic Hepatitis C Patients Through Direct-Acting Antivirals Therapy

“…The present study was motivated by the limited availability of Brazilian research documenting and recording real-life data regarding the success rates of DAAs (12)(13)(14) . Here we evaluated the epidemiological profile of patients with chronic hepatitis C and the rate of SVR of all individuals treated in accordance to the Clinical Protocol and Therapeutic Guidelines of 2015 that attended the Reference Center for the treatment of chronic hepatitis C of the Federal University of Rio Grande, termed Center for the Application and Monitoring of Injectable Medicines (CAMMI).…”