Background Telaprevir is a new drug for the treatment of chronic hepatitis C virus (HCV).

Purpose To compare the safety of telaprevir treatment between HCV mono-infected patients and HIV co-infected patients.

Materials and methods Retrospective observational study of 1 year and 6 months (January 2012–June 2013) conducted in our Health Department. Patients were included with HCV genotype 1 who had completed 12 weeks of treatment with telaprevir.

Demographic characteristics were collected and related to treatment, adverse drug reactions (ADRs) reported, transfusion requirements or supportive treatment, ribavirin dose reductions and treatment suspensions.

The ADRs recorded were classified according to Division of AIDS (DAIDS.v.1.0)

Results We included 88 patients, 40.9% co-infected with HIV.

The groups were similar in demographic characteristics, patient type and genotype, however the rate of cirrhosis was higher in the co-infected group (97.2% vs. 53.8% p < 0.005).

Toxicity including all grades: no differences between the groups for anaemia, neutropenia, lymphopenia, thrombocytopenia, hyperuricaemia and renal toxicity. The incidence of hyperbilirubinaemia was higher in the co-infected group (50% vs. 26.9% p = 0.02).

There was a higher incidence of hyperbilirubinaemia G3-G4 in the co-infected group (27.8% vs. 3.8% p = 0.002). In contrast, the incidence of neutropenia G3-G4 was higher in mono-infected group (25% vs 8.3%, p = 0.04).

The dose of ribavirin was modified more in the co-infected group than in the mono-infected group (65.8% vs. 30.6% p = 0.001), and exogenous erythropoietin used more often (38.5% vs. 13.9% p = 0.01). No differences were observed in the transfusion rate (21.2% vs. 11.1%, p = 0.173). Colony stimulating factors were used only in one patient in the mono-infected group.

Conclusions Similar toxicity profiles were observed between the two groups, although with a higher incidence of hyperbilirubinaemia in the co-infected group, which could be related to the use of the antiretroviral atazanavir.

No conflict of interest.