Study results support the long-term use of tenofovir disoproxil fumarate (DF) for chronic hepatitis B virus (HBV), showing that it can suppress the virus and lead to regression of fibrosis and cirrhosis in patients after 5 years' treatment.
"The histological response and regression of fibrosis seen in this study are probably due to the potent viral suppression achieved with long-term use of tenofovir DF," say Patrick Marcellin (INSERM, Clichy, France) and colleagues.
"In clinical practice, maintenance of viral suppression is feasible given the overall favourable safety profile and the absence of treatment-limiting toxicity."
The study, published in TheLancet, included 348 patients who had been enrolled in phase III studies of tenofovir DF and continued open-label treatment during a planned 7 years.
After 5 years, 330 of 334 patients tested showed HBV viral suppression. Overall, 51% of patients had regression of fibrosis and 87% showed histologic improvement.
Additionally, 96% of patients showed regression of cirrhosis and only 5% of patients who had no cirrhosis at baseline (Ishak score <4) showed a worsening in Ishak score. Notably, 74% of the 96 patients who initially presented with cirrhosis (Ishak score ≥ 5) showed regression of fibrosis and were no longer cirrhotic.
Interestingly, the authors found that body mass index (BMI) was an independent predictor for cirrhosis regression, such that normal weight patients (BMI <25 kg/m2) had 18.9-fold increased odds of regression compared with obese patients (BMI ≥30 kg/m2). They say that this finding needs further investigation.
"This study and many others now support the recommendation that patients with chronic hepatitis B receive long-term treatment with a potent oral antiviral agent with a high barrier to resistance," say Michele Tana and Jay Hoofnagle, from the National Institutes of Health, Bethesda, Maryland, USA, in an accompanying editorial.
However, they add that many challenges and unanswered questions remain in the long-term treatment of HBV, such as how long patients should be treated for and how best safety should be monitored.
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