medwireNews: Among patients with hepatitis B virus (HBV)-related decompensated cirrhosis, first-line tenofovir disoproxil fumarate (TDF) therapy not only reduces HBV DNA levels, but also improves hepatic function, indicates a real-world South Korean study.
After at least 48 weeks of treatment with TDF 300 mg/day, the average decrease in HBV DNA levels was comparable between the 57 patients with decompensated cirrhosis and the 117 with compensated cirrhosis.
And over two-thirds (70.2%) of patients with decompensated cirrhosis achieved a complete virologic response (CVR) at the 1-year mark, defined as a reduction in HBV DNA levels to less than 116 copies/mL. However, this rate was significantly lower than the 88.9% rate observed in the compensated cirrhosis group (p=0.005).
Moreover, in multivariate analysis the presence of decompensated cirrhosis at baseline adversely affected the likelihood of achieving CVR, with a significant odds ratio of 0.340 (p=0.018).
Noting that “patients without CVR show comparable risks of hepatic events and mortality to untreated patients,” the study authors recommend close monitoring of HBV DNA levels and frequent checks for hepatic events among TDF-treated decompensated patients.
TDF therapy also improved hepatic function among those with decompensated liver disease. At the 1-year timepoint, mean Child-Turcotte-Pugh (CTP) and model for end-stage liver disease (MELD) scores were significantly lower than at baseline, at 6.3 versus 8.0 and 10.5 versus 13.4, respectively (p<0.001 for both comparisons).
Furthermore, 68.4% of patients achieved CTP class A (score of 5 or 6) after TDF treatment and half (49.1%) showed an improvement in the CTP score of at least 2 points.
More patients in the decompensated cirrhosis than the compensated cirrhosis group experienced a rise in serum creatinine levels of at least 0.5 mg/dL from baseline, at 7.0% and 2.5%, respectively, but the difference was not statistically significant.
Lead researcher Myeong Jun Song (The Catholic University of Korea, Daejeon) and colleagues say that TDF therapy was “safe” with regard to renal function in both groups, but they nonetheless recommend careful monitoring.
They acknowledge that larger prospective studies with longer follow-up are needed to confirm the findings, but conclude in the World Journal of Gastroenterology that TDF appears to be “useful” for the treatment of patients with HBV-related decompensated cirrhosis.
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