Real-world observational experience with direct-acting antivirals for hepatitis C: baseline resistance, efficacy, and need for long-term surveillance

Abstract

The aim of this study was to obtain real-world, US, observational data on the effect of baseline resistance-associated substitutions (RASs) on achieving sustained virologic response (SVR) in hepatitis C (HCV) patients treated with direct-acting antiviral (DAA) regimens; the need for long-term follow-up in post-SVR patients. It is uncertain if the presence of RASs limits efficacy to DAAs. Once SVR is achieved, society guidelines recommend long-term surveillance for hepatocellular carcinoma in certain patients. Real-world data are limited on these topics. Adult patients treated with DAAs at community hepatitis clinics between January 2015 and April 2017 were included in this study. Baseline resistance testing was performed before treatment. Per guidelines, post-SVR long-term monitoring was required in patients with F3 to F4 fibrosis before treatment or with elevated ALT levels (>19 U/L females; >30 U/L males). A total of 875 chronic, mostly GT1a (60%) HCV patients were treated with an approved DAA regimen. Average baseline AST and ALT were 75 and 67 U/L, respectively, and 47% had F3 to F4 fibrosis at baseline. SVR was achieved in 863 (98.6%) patients despite a high presence of baseline RASs (61%). Long-term monitoring was required post-SVR in 539 patients (62%). In a real-life, US cohort of HCV-infected patients, nearly all patients achieved SVR with available DAA regimens regardless of baseline RASs. Approximately two-thirds of these patients required long-term follow-up, despite viral eradication.

Out-of-Hospital Treatment of Hepatitis C Increases Retention in Care among People Who Inject Drugs and Homeless Persons: An Observational Study

“…In our study, although the rate of DAAs therapy completion was lower among patients treated in hospital, when we consider the entire subset of subjects who completed treatment, we observed similarly high virological success rates regardless from treatment setting with no statistically significant differences. The 93.9% of SVR 12 in our overall treated population confirmed the efficacy of regimens with DAAs as reported in the real-world published studies [ 28 ]. Small sample size and its retrospective nature are limitations of the study.…”

Metabolic Evaluation in Patients With Hepatitis C Treated With Direct Antiviral Agents

“…In our study, the distribution of the degree of fibrosis among the patients evaluated before starting treatment was F0-F1 15.4%, F2 15.4%, F3 23.1%, and F4 46.2%, compared to a Brazilian study Castelo et al (54), involving 313 monitored in the public health system, where 42.8% of patients who underwent TE had cirrhosis. In ratification of our findings, in the study conducted by Loo et al (55) of the 411 patients evaluated at the beginning of treatment, 47.6% had basal fibrosis from F3 to F4. Current European and United States guidelines recommend only longterm follow-up in patients with the presence of advanced fibrosis in the pre-treatment and maintenance of elevated enzymes after treatment.…”

“…In large centers, patients treated with DAA regimens can achieve SVR rates that approach 99%, being comparable to the results demonstrated in controlled clinical trials. However, according to Loo et al (55), approximately two thirds of patients continue to need long-term follow-up due to advanced liver disease, despite viral eradication. These findings indicate the possibility of additional underlying chronic liver disease, for example, NAFLD or alcoholic liver disease, which can lead to further fibrosis progression and an increased risk of hepatocellular carcinoma.…”

Hepatocellular carcinoma risk in hepatitis C stage‐3 fibrosis after sustained virological response with direct‐acting antivirals

“…Hepatitis C virus (HCV) is an independent risk factor for the development of liver fibrosis and the most common cause of hepatocellular carcinoma (HCC) in developed countries 1 . New treatment regimens based on direct‐acting antivirals (DAA) achieve high rates of sustained virological response (SVR) irrespective of genotype, stage of liver disease and experience of therapy, with the response remaining durable in 99% of patients 2,3 …”