Published online May 6, 2017. doi: 10.4292/wjgpt.v8.i2.137
Peer-review started: November 5, 2016
First decision: December 13, 2016
Revised: January 14, 2017
Accepted: February 8, 2017
Article in press: February 9, 2017
Published online: May 6, 2017
Processing time: 180 Days and 11.8 Hours
To investigated the real-world effectiveness and safety of various regimens of interferon-free treatments in patients infected with hepatitis C virus (HCV).
We performed an observational study to analyze different antiviral treatments administered to 462 HCV-infected patients, of which 56.7% had liver cirrhosis. HCV RNA after 4 wk of treatment and at 12 wk after treatment sustained virologic response (SVR) as well as serious adverse events (SAEs) was analyzed first for the whole cohort and then separately in patients who met or did not meet the inclusion criteria of a clinical trial (CT-met and CT-unmet, respectively).
The most frequently prescribed treatment was simeprevir/sofosbuvir (36.4%), followed by sofosbuvir/ledipasvir (24.9%) and ombitasvir/paritaprevir/ritonavir (r)/dasabuvir (19.9%). Ribavirin (RBV) was administered in 198 patients (42.9%). SVRs occurred in 437/462 patients (94.6%). The SVRs ranged between 93.3% and 100% for genotypes 1-4. SVRs were achieved in 96.2% patients in the CT-met group vs 91.9% patients in the CT-unmet group (P = 0.049). Undetectable HCV RNA at week 4 occurred in 72.9% of the patients. In the univariate analysis, the factors associated with SVRs were lower liver stiffness, absence of cirrhosis, higher platelet count, higher albumin levels, no RBV dose reduction, undetectable HCV RNA at week 4 and CT-met group. In the multivariate analysis, only albumin was an independent predictor of treatment failure (P = 0.04). Eleven patients (2.4%) developed SAEs; 5.2% and 0.7% of the patients in the CT-unmet and CT-met groups, respectively (P = 0.003).
A high proportion of patients with HCV infection achieved SVRs. For patients who did not meet the CT criteria, treatment regimens must be optimized.
Core tip: Our study analyzes the hepatitis C virus (HCV) most common genotypes treatment and all the possible combinations with direct-acting antiviral agents which are nowadays available in our country. We have found sustained virological response rates up to 90%, even in genotypes 1 and 3. The current study analyzes HCV RNA after 4 wk of treatment and 12 and 24 wk after the end of the treatment, as well as the adverse events. We analyze, separately, the patients who meet or do not meet the inclusion criteria of a clinical trial, finding that in this last group the response is lower.