Dataset Information

A randomized open label trial of tenofovir monotherapy versus tenofovir plus telbivudine in spontaneous reactivation of hepatitis B.

ABSTRACT:

Background/aim

Acute-on-chronic liver failure (ACLF-B) in spontaneous reactivation of chronic hepatitis B (SR-CHB) has high mortality. Tenofovir disoproxil fumarate (TDF) improves survival by ~40% in ACLF-B but is potentially nephrotoxic. Combining telbivudine (LDT) with TDF may negate this risk and could boost rapid viral clearance and improve clinical outcomes.

Patients and methods

Seventy consecutive patients with SR-CHB were randomized to TDF (300 mg/day, n = 35) or TDF plus LDT (600 mg/day; n = 35). In all, 25 had ACLF-B and none had option for liver transplantation. Primary endpoint was survival at 3 months. Secondary endpoints were survival at 3 months in ACLF-B, serial reduction in hepatitis B virus (HBV) DNA, hepatitis B surface antigen (HBsAg) loss and liver-related complications.

Results

Overall baseline clinical and laboratory parameters in the two groups were comparable. Reduction in HBV DNA at weeks 2, 4 and 12 was independent of treatment groups and presence of ACLF-B (P < 0.01). All six patients with HBsAg loss at 12 weeks had lower HBV DNA at baseline and none had ACLF-B. Patients with no ACLF-B had more rapid decline in bilirubin and alanine aminotraminase at week 2 compared with ACLF-B. Patients on TDF plus LDT showed significant improvement in AKI on follow-up (five of six patients) compared with TDF monotherapy (none of six patients) and had less reduction in estimated glomerular filtration rate at week 12. Eight of 10 patients with liver-related deaths received TDF monotherapy (P = 0.02). New-onset septic shock, TDF monotherapy, e-antibody positivity, and higher baseline model for end-stage liver disease score were predictors of mortality in ACLF-B. None had treatment-related severe adverse effects.

Conclusion

Addition of LDT to tenofovir is safe and may be renoprotective in spontaneous reactivation of hepatitis B. Combination therapy improves survival in ACLF-B despite comparable HBV DNA suppression to tenofovir monotherapy.

SUBMITTER: Jindal A

PROVIDER: S-EPMC6784432 | biostudies-literature | 2019 Sep-Oct

REPOSITORIES: biostudies-literature

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Publications

A randomized open label trial of tenofovir monotherapy versus tenofovir plus telbivudine in spontaneous reactivation of hepatitis B.

Jindal Ankur A Vyas Ashish A Sharma Manoj M Kumar Guresh G Sarin Shiv K SK

Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association 20190901 5

<h4>Background/aim</h4>Acute-on-chronic liver failure (ACLF-B) in spontaneous reactivation of chronic hepatitis B (SR-CHB) has high mortality. Tenofovir disoproxil fumarate (TDF) improves survival by ~40% in ACLF-B but is potentially nephrotoxic. Combining telbivudine (LDT) with TDF may negate this risk and could boost rapid viral clearance and improve clinical outcomes.<h4>Patients and methods</h4>Seventy consecutive patients with SR-CHB were randomized to TDF (300 mg/day, n = 35) or TDF plus L ...[more]

PMID: 31044748

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Dataset Information

A randomized open label trial of tenofovir monotherapy versus tenofovir plus telbivudine in spontaneous reactivation of hepatitis B.

Background/aim

Patients and methods

Results

Conclusion

Publications

A randomized open label trial of tenofovir monotherapy versus tenofovir plus telbivudine in spontaneous reactivation of hepatitis B.

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