[Safety and efficacy of telaprevir in patients with HIV and hepatitis C virus coinfection].

Related to the use of telaprevir in patients with HIV and genotype 1 hepatitis C virus, there is available data from a phase IIb clinical trial in patients not previously treated for HCV, study 110; and preliminary data from a real practice study in patients with previous failure to a HCV treatment, study ARNSHC26 (TelapreVIH). Additionally, there are two ongoing phase III studies in coinfected patients, C3008 and 115, both in naive and previously treated patients. In the 110 study, rates of sustained viral response (SVR) in patients receiving the triple combination of pegylated interferon + ribavirin + telaprevir was 74%. This SVR rate is similar to those reported in treatment-naïve patients with genotype 1 HCV monoinfection who received pegylated interferon + ribavirin + telaprevir. Similarly, the adverse effects in this trial did not differ from those found in patients with genotype 1 HCV monoinfection. Telaprevir has been approved for use in patients with HCV genotype 1 monoinfection by the European Commission through a centralized procedure. Telaprevir label includes data on coinfected patients, covering efficacy, security, and practical management with different antirretroviral drugs. The Spanish Agency for Medications and Health Care Products has established recommendations that regulate and allow the use of telaprevir in patients with HIV/HCV genotype 1 coinfection. The most important restrictions on the use of telaprevir established by the Agency are as follows: a) patients with stage F3-F4 liver fibrosis on liver biopsy or liver stiffness ≥ 9.5kPa can be treated; b) in the absence of advanced fibrosis, telaprevir can be used to treat severe extrahepatic manifestations of HCV infection; c) patients with cirrhosis must have Child-Pugh stage A.