Ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin in HCV genotype 1 infected patients who failed previous protease inhibitor therapy

Abstract

Aim of the study: Combination of ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin (3DDA±RBV) therapy is shown to be effective in HCV genotype 1 (GT1) infected patients. However, sparse data exist in patients who failed previous boceprevir or telaprevir based therapies. Real life efficacy and safety of this combination were evaluated in HCV GT1b infected patients (mostly cirrhotics) with compensated liver disease who failed previous boceprevir or telaprevir based therapies more than a year before.

Material and methods: Data of previous protease inhibitor failure patients, treated with 3DAA+RBV for 12 weeks (GT1b and/or non-cirrhotics) or 24 weeks (non-GT1b cirrhotics), were retrospectively collected.

Results: Population characteristics: boceprevir/telaprevir-failure: 82/45, GT1b: 117, cirrhotic: 111 (87.4%). SVR12/24 was observed in 103/105 patients (98.1%) of those who reached either time point. Four SAEs reported: one death due to myocardial infarction, another due to recurrent hepatocellular carcinoma after achieving SVR12, two hospitalizations (elevation of transaminases, pneumonia). Grade ≥ 3 AEs or laboratory abnormalities were reported in < 10% of patients; they were transient in all patients. No early discontinuation of drugs due to SAE has been reported.

Conclusions: One year after previous failure of boceprevir or telaprevir based therapy, 12 weeks of 3DAA+RBV combination in HCV GT1b infected patients is similarly effective and safe as in those with no previous HCV therapy, even in the presence of cirrhosis. These findings might be of particular interest in settings where alternative therapies for such patients are not available or not affordable.

Keywords: cirrhosis; direct acting antiviral drugs; hepatitis C virus; protease inhibitor.

Fig. 1

Disposition of patients and key HCV RNA results *One patient died due to myocardial infarction while on therapy; not included in modified ITT analysis. # One patient reached SVR12, but died due to recurrent hepatocellular carcinoma and deterioration of liver disease before EOT+24 weeks time point; not included in modified ITT SVR24 analysis. §50 patients had negative HCV RNA testing at both EOT+12 and EOT+24 time points; all other patients had HCV RNA testing only at one of these time points. EOT – end of treatment, HCV – hepatitis C virus, ITT – intent to treat, N – number of patients, RNA – ribonucleic acid, SVR – sustained virological response