ISSN : 2146-3123
E-ISSN : 2146-3131

Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey
Orhan Yıldız 1, Sıla Akhan 2, Elif Sargın Altınok 2, Mustafa Kemal Çelen 3, Onur Ural 4, Nazlım Aktuğ Demir 4, Şua Sümer 4, Süda Tekin Koruk 5, Şükran Köse 6, Fatime Korkmaz 7, Ziya Kuruüzüm 8, Nazan Tuna 9, Serpil Taheri 10, Murat Sayan 11
1Department of Infectious Diseases and Clinical Microbiology, Erciyes University Faculty of Medicine, Kayseri, Turkey
2Department of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, Kocaeli, Turkey
3Department of Infectious Diseases and Clinical Microbiology, Dicle University Faculty of Medicine, Diyarbakır, Turkey
4Department of Infectious Diseases and Clinical Microbiology, Selçuk University Faculty of Medicine, Konya, Turkey
5Department of Infectious Diseases and Clinical Microbiology, Harran University Faculty of Medicine, Şanlıurfa, Turkey
6Department of Infectious Diseases and Clinical Microbiology, Tepecik Training and Research Hospital, İzmir, Turkey
7Department of Infectious Diseases and Clinical Microbiology, Konya Training and Research Hospital, Konya, Turkey
8Department of Infectious Diseases and Clinical Microbiology, Dokuz Eylül University Faculty of Medicine, İzmir Turkey
9Department of Infectious Diseases and Clinical Microbiology, Sakarya University Faculty of Medicine, Sakarya, Turkey
10Department of Medical Biology, Erciyes University Faculty of Medicine, Kayseri, Turkey
11Clinical Laboratory, PCR Unit, Kocaeli University Faculty of Medicine, Kocaeli, Turkey
DOI : 10.5152/balkanmedj.2015.15366
Pages : 266-272

Abstract

Background: The use of pegylated interferon alpha and ribavirin (PegIFN/RBV) for the retreatment of chronic hepatitis C virus (HCV) infection without a sustained virological response (SVR) prior to PegIFN/RBV treatment has resulted in low success rates.

Aims: To investigate the efficacy and safety of telaprevir (TVR) in combination with PegIFN/RBV in patients infected with HCV genotypes 1 and 4 who were previously treated with PegIFN/RBV and failed to achieve SVR.

Study Design: Multi-center, retrospective, cross-sectional study.

Methods: The study included 111 patients: 80 prior relapsers, 25 prior null responders, and six prior partial responders to PegIFN/RBV treatment. The patients were given TVR/PegIFN/RBV for 12 weeks, followed by a 12-week PegIFN/RBV treatment; virological response results were assessed at weeks 4, 12, and 24. Treatment was discontinued in patients with HCV RNA >1000 IU/mL at week 4 or with negative RNA results at week 4 but >1000 IU/mL at week 12. Rapid virological response (RVR), early virological response (EVR), extended rapid virological response (eRVR), and virological response at 24th week of treatment were evaluated. The side effects of combination therapy and the rates of treatment discontinuation were investigated.

Results: The mean age of the patients was 56.02±9.96 years and 45.9% were male. Ninety-one percent of the patients were infected with viral genotype 1, 69.6% with the interleukin (IL) 28B genotype CT and 20.2% were cirrhotic. The RVR rate was 86.3% in prior relapsers, 56% in prior null responders, and 50% in prior partial responders (p=0.002). EVR rates in those groups were 91.3%, 56%, and 83.3%, respectively (p<0.001). eRVR rates were 83.8% in prior relapsers, 48% in prior null responders, and 50% in prior partial responders (<0.001). The virological response at the 24th week of treatment was found to be the highest in prior relapsers (88.8%); it was 56% in prior null responders and 66.7% in prior partial responders (p<0.001). Common side effects were fatigue, headache, anorexia, malaise, anemia, pruritus, dry skin, rash, dyspepsia, nausea, pyrexia, stomachache, and anorectal discomfort. All treatments were discontinued due to side effects in 9.9% of patients.

Conclusion: High virological response rates were obtained with TVR/PegIFN/RBV treatment. Although side effects were frequently observed, the discontinuation rate of combination therapy was low. 

Keywords : Chronic hepatitis C, telaprevir, therapy, treatment-experienced.
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