Publication: Treatment outcome of tenofovir disoproxil fumarate (TDF) among chronic hepatitis B patients: A retrospective review in Hospital Sultanah Nur Zahirah (HSNZ)
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Date
2022
Authors
Wamzah, Ahmad Wafiy
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Abstract
Background: Tenofovir disoproxil fumarate (TDF) is among the high barrier nucleotide analogue currently preferred as first-line therapy in chronic hepatitis B patients. Its safety and efficacy have been confirmed in 2 phase III clinical trials. However, no reports have been published on the experience with TDF among Southeast Asian populations, including Malaysia. The objectives of the study are to determine the proportion of chronic hepatitis B patients achieving complete virological suppression after being treated with TDF at 12 months and 24 months of therapy in Hospital Sultanah Nur Zahirah and to identify factors associated with the complete virological suppression. Methods: This was a retrospective cohort study using secondary data, which involved chronic hepatitis B patients treated with Tenofovir Disoproxil Fumarate (TDF) for at least 3 months, between 1st January 2017 and 31st December 2021. The proportion of chronic hepatitis B patients who achieved complete virological response (CVR) at the end of 12 and 24 months of therapy was evaluated. Additionally, the association of complete virological response with clinico demographic factors, clinical outcome (liver cirrhosis-related complications, development of hepatocellular carcinoma), biochemical response, and survival status was also analysed. Result: 108 patients who fulfilled the inclusion criteria were identified. 60.5% (49 out of 81) patients achieved complete virological response at 12 months of TDF therapy, and 76 out of 90 (84.4%) patients achieved complete virological response at the end of 24 months of TDF therapy. Analysis using multiple logistic regression showed the presence of HBeAg antigen as the only factor associated significantly with complete virological suppression. (OR= 8.246, 95% CI: 2.093 – 32.487, p-value = 0.003). Using chi-square tests, the association of complete virological suppression at 24 months of TDF therapy was shown to be statistically significant (p-value < 0.001) with the reduction of liver cirrhosis complications, namely variceal bleeding,ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, and the incidence of hepatocellular carcinoma. Normalisation of ALT levels was shown to be significantly associated with complete virological suppression at 12 months and 24 months of TDF therapy. Conclusion: Our experience from this study shows that TDF is an effective therapy for chronic hepatitis B patients in our population. Induction of long-term suppression of HBV DNA should be the primary endpoint of treating chronic Hepatitis B patients as this is significantly associated with favourable clinical outcomes, preventing further disease progression and development of hepatocellular carcinoma, thus improving overall survival.
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Keywords
HBV DNA levels , liver cirrhosis