Incidence of virological failure and emergence of resistance with twice daily versus every 8 h administration of telaprevir in the OPTIMIZE study

• Published in: Antiviral therapy 2013-01, Vol.18, p.A52-A52
• Main Authors: Dierynck, I, Ghys, A, Witek, J, Luo, D, Janssen, K, Daems, B, Picchio, G, Buti, M, De Meyer, S
• Format: Article
• Language: English
• Subjects: Hepatitis C virus
• ISSN: 1359-6535

In the Phase III OPTIMIZE study in treatment-naive genotype 1 (GT1) HCV-infected patients, the efficacy of telaprevir (T) in combination with peginterferon/ribavirin (PR) twice daily was noninferior to T/PR every 8 h (q8h), with SVR12 rates of 74% versus 73%, respectively. Viral resistance was evaluated to compare the selective pressure of both dosing regimens. HCV NS3-4A population sequencing was performed at baseline and time of failure. Resistance of T variants was classified into lower-level, higher-level and FC[lessthan]3. On-treatment virological failure (VF) was defined as discontinuation due to a virological stopping rule and/or having viral breakthrough. Relapse was defined as HCV RNA[greater than or equal]25 IU/ml after previous HCV RNA[lessthan]25 IU/ml at planned end of treatment. In OPTIMIZE, the prevalence of T-resistant variants at baseline was low and did not preclude successful treatment with a T/PR regimen. There was no difference between T q8h and twice daily dosing in terms of selection of resistance, and viral resistance profiles were consistent with previous observations.