Comparative Study on the Response of Tenofovir Mono Therapy Versus Tenofovir Plus Telbivudine Dual Therapy in Patients With Hepatitis B Virus Related Acute on Chronic Liver Failure

Abstract

Background and Aim: Severe acute spontaneous exacerbation of CHB leading to ACLF is extremely poor, with mortality ranging from 30% to 70%. Therefore, early and rapid reduction of HBV DNA is the essence of therapy in ACLF-B. Methods: Patients with spontaneous reactivation of HBV [(ALT >5 × ULN or >2 × baseline) and HBV DNA >20,000 IU/ml] were randomized to Tenofovir mono therapy (300 mg/day) or Tenofovir plus Telbivudine (600 mg/day) dual therapy along with standard medical treatment. Clinical and biochemical parameters were evaluated at baseline, 1 week, 4 weeks and at 3 months. Virological evaluation was done at baseline and at 3 months. End point was reduction of HBV DNA, reduction of liver related complication, therapy related adverse effects and survival at 3 months. Results: 27 patients were enrolled and 15 of them received mono therapy with Tenofovir and 12 patients received dual therapy (Tenofovir plus Telbivudine). Baseline parameters in two groups had no significant difference. Both groups significantly improve bilirubin, ALT, INR, CTP score and MELD score. Only MELD score showed significant improvement in patient with dual therapy at 3 months in comparison of mono therapy. 11 patient on Tenofovir mono therapy showed undetected HBV DNA (91.7%) at 3 month and one patient had detectable HBV DNA. 10 patients on dual therapy had undetectable HBV DNA (100%). Patients receiving dual therapy showed significant improvement in AKI on follow up compared to those on mono therapy. Among 5 deaths, 3 had received mono therapy and 2 had received dual therapy. Predictors of mortality were high S. bilirubin (25.8 ± 7.8), HBV DNA (5.18 ± 1.17 log10 IU/ml), MELD score (33.0 ± 4.2) and CTP score (12.2 ± 0.8) (Table 1).Table 1Comparison of Meld Score and CTP Score Between Two Study Groups After 90 Days (N = 27).Tenofovir Plus Telbivudine (n = 10)Tenofovir (n = 12)P valueNo. (%)No. (%)MELD score<156(60.0%)2(16.7%)0.035s>154(40.0%)10(83.3%)CTP score<86(60.0%)5(41.7%)0.391 ns>84(40.0%)7(58.3%)Data were expressed frequency and percentage.P value reached from Chi-square test, ns = not significant, s = significant. Open table in a new tab Data were expressed frequency and percentage. P value reached from Chi-square test, ns = not significant, s = significant. Conclusion: In ACLF-B combination of Telbivudine plus Tenofovir is potentially safer with less risk of Tenofovir related nephrotoxicity and hence improved outcomes (Figure 1). The authors have none to declare.