Authors' objectives: 1. To evaluate the efficacy of each protease inhibitor (PI) with standard bitherapy versus standard bitherapy and to evaluate the relative efficacy of boceprevir vs. telaprevir in adult patients with untreated chronic hepatitis C virus (HCV) genotype 1 infection. 2. To evaluate the efficacy of each PI with standard bitherapy versus standard bitherapy and to evaluate the relative efficacy of boceprevir vs. telaprevir in adult patients with previously treated chronic HCV genotype 1 infection. 3. To evaluate the safety of each PI with standard bitherapy versus standard bitherapy and to evaluate the relative safety of boceprevir vs. telaprevir in untreated and previously treated adult patients with chronic HCV genotype 1 infection. 4. To evaluate the efficiency of each PI in untreated and previously treated adult patients with chronic HCV genotype 1 infection. 5. To estimate the budgetary impact of adding boceprevir or telaprevir to the standard treatment on the Andalusian Public Health System.

Authors' recommendations: Efficacy of the protease inhibitors in adult patients with chronic infection with hepatitis C virus genotype 1 Naïve patients Boceprevir with standard treatment increases the efficacy in terms of SVR in naïve patients. According to subgroups, boceprevir with standard treatment increases the efficacy in terms of SVR in naïve patients with genetic polymorphism IL28B CT and TT, and in patients without fibrosis, with portal fibrosis without septa and portal fibrosis with few septa. Triple therapy with boceprevir is as effective as standard therapy in terms of SVR in naïve patients with undetectable plasmatic viral load in week 4. Telaprevir with standard treatment increases the efficacy in terms of SVR in naïve patients. According to subgroups, telaprevir with standard treatment increases the efficacy in terms of SVR in naïve patients independently of the genetic polymorphism IL28B, and telaprevir increases the efficacy in patients without fibrosis, minimal fibrosis, bridging fibrosis and advanced fibrosis. Standard treatment is more effective than triple therapy with telaprevir in terms of SVR in naïve patients with undetectable plasmatic viral load in week 4. Pretreated patients Boceprevir with standard treatment increases the efficacy in terms of SVR in prior relapse patients. Boceprevir with standard treatment increases the efficacy in terms of SVR in prior partial response patients. Null patients were not included in the RCT RESPOND-2. According to subgroups, boceprevir with standard treatment increases the efficacy in terms of SVR, in previously treated patients independently of the grade of fibrosis and in patients with genetic polymorphism IL28B CT. Telaprevir with standard treatment increases the efficacy in terms of SVR in prior relapse patients. According to subgroups, in prior relapse patients, telaprevir with standard treatment increases the efficacy in terms of SVR, independently of the grade of fibrosis and the genetic polymorphism IL28B CT. Telaprevir with standard treatment increases the efficacy in terms of SVR, in prior partial response patients. Telaprevir with standard treatment increases the efficacy in terms of SVR, in null response patients to previous treatment. Safety of the protease inhibitors In naïve patients, as well as in previously treated patients, boceprevir with standard treatment increases the rate of dysgeusia. Moreover, boceprevir increases the rate of anaemia, neutropenia and thrombocytopenia of grade 3 and higher grade. In naïve patients, as well as in previously treated patients, telaprevir with standard treatment increases the rate of dysgeusia, thrombocytopenia, rash and pruritus of grade 3 and higher grade. Relative efficacy and safety of protease inhibitors Based on adjusted indirect comparisons analyses: There are no differences in terms of SVR between boceprevir and telaprevir in naïve patients. In the subgroup of patients without fibrosis, portal fibrosis with few septa and without septa, there were no differences in terms of SVR between both PI. There are no differences in terms of SVR between boceprevir and telaprevir in prior relapse patients. There are no differences in terms of SVR between boceprevir and telaprevir in prior partial response patients. Regarding to any grade of anaemia and patients with Hb < 8.5g/dl, there are no differences between boceprevir and telaprevir, either in naïve patients or in previously treated patients. Efficiency In the economic evaluations analyzed, both PI are considered cost-effective drugs. Incremental cost-effective ratios are more favourable for patients with worse basal status and patients treated with response guided therapy. Boceprevir has a cost per NNT more favourable for naïve patients and prior partial response patients, whereas telaprevir has a cost for NNT more favourable for prior relapse patients. Null responder patients are only included in the RCT REALIZE (telaprevir), and not in the RCT RESPOND-2 (boceprevir). The budgetary impact of adding to the standard treatment a PI in 2012, if only advanced fibrosis and cirrhosis patients are considered for the treatment (F3 and F4), would be approximately € 14,460,000 with telaprevir and € 11,300,000 with boceprevir. Those data represent an increment of 2.53% and 1.98% of SSPA

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/inhibidores-de-la-proteasa-boceprevir-y-telaprevir-en-el-tratamiento-de-pacientes-monoinfectados-por-el-vhc-eficacia-seguridad-y-eficiencia-comparada-informe-de-evaluacion-de-medicamentos/

Year Published: 2012

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_1-2012_InhibidoresProteasa.pdf

URL for additional information: http://www.juntadeandalucia.es/salud/servicios/contenidos/nuevaaetsa/up/Protease_inhibitors_Executive_Sum.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)