Volume 35, Issue 10, pages 2265–2274, October 2015
1 Department of Gastroenterology, Koç University Hospital, Zeytinburnu, Istanbul, Turkey
2 Department of Gastroenterohepatology, Istanbul Faculty of Medicine, Istanbul University, Capa, Istanbul, Turkey
3 Department of Microbiology, Istanbul Faculty of Medicine, Istanbul University, Capa, Istanbul, Turkey
4 Department of Pathology, Istanbul Faculty of Medicine, Istanbul University, Capa, Istanbul, Turkey
* Correspondence
Sabahattin Kaymakoglu, M.D., Professor, Department of Gastroenterohepatology, Istanbul Faculty of Medicine, Istanbul University, Capa 34390, Istanbul, Turkey
Tel: +902124142000 – 31140
Fax: +902126319743
e-mail: [email protected]
To evaluate the efficacy of tenofovir in chronic hepatitis B (CHB) patients with adefovir resistance (ADF-R) and suboptimal response to adefovir (ADF-S).
Methods
Nucleos(t)ide analogue (NA)-naïve patients and patients with previous adefovir failure receiving tenofovir therapy for at least 6 months were included in the study. Biochemical and virological tests were obtained at baseline and 3-month intervals in the first year and every 6 months thereafter. The primary outcome measure was complete virological response (CVR) (HBVDNA < 20 IU/ml). CVR rates were calculated by Kaplan–Meier analysis, and a multivariate Cox proportional hazard model was generated to find out factors independently associated with CVR.
Results
A total of 165 patients (118 men, mean age 42 ± 12, 64 HBeAg+) were included in the study. There were 105 patients in NA-naïve, 32 patients in ADF-S and 28 patients in ADF-R groups. All patients in the ADF-R group had multidrug resistance patterns. Mean duration of tenofovir treatment was 29 ± 14 months. CVR rates in NA-naïve, ADF-S and ADF-R groups were 65% vs. 75% vs. 58% at 12th month, 77% vs. 87% vs. 79% at 24th month and 83% vs. 94% vs. 79% at 36th month respectively. According to multivariate Cox regression model, HBeAg positivity (HR = 0.56, 95%CI 0.36–0.86, P = 0.008), high baseline HBVDNA level (HR = 0.64, 95%CI 0.55–0.74, P < 0.001) and ADF-R (HR = 0.47, 95%CI 0.28–0.81, P = 0.006) were independent predictors for CVR. Seven patients encountered mild renal dysfunction and were managed by dose adjustments.
Conclusion
CVR rates during the follow-up show that tenofovir has a decreased, yet still potent in vivo efficacy against multidrug-resistant strains of HBV.