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Cirrhosis, fibrosis regressed among patients with chronic HBV taking tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate caused long-term viral suppression and fibrosis regression with few adverse events in patients with chronic hepatitis B, according to recent results.

In a 7-year, open-label study, researchers evaluated 585 patients with chronic HBV treated with tenofovir disoproxil fumarate (DF). Liver biopsies were performed before open-label treatment, and again at 240 weeks. All participants had been enrolled in a prior 48-week, randomized double blind trial comparing tenofovir DF with adefovir dipivoxil, and 489 participants in this follow-up study completed all 240 weeks of treatment.

Among 348 patients who received biopsy after completing treatment, 87% experienced histological improvement and 51% indicated fibrosis regression after 240 weeks of therapy (P<.0001). Ninety-one percent of patients with baseline Ishak scores greater than 2 experienced improved fibrosis, and investigators noted that patients with higher liver injury scores benefited the most (P<.0001).

Fibrosis worsened in 5% of cases during treatment. Twenty-eight percent of biopsied patients had cirrhosis at baseline; 74% of these cases were no longer cirrhotic at 5 years, while three participants developed cirrhosis during therapy (P<.0001 for difference). Multivariate analysis indicated an association between BMI and cirrhosis regression (OR=7.4, 95% CI, 1.87-29.41 for BMI less than 25 kg/m2 compared with 25 kg/m2 or greater)

Adverse events occurred in 16% of all participants, including nine serious events considered treatment-related and eight patients who withdrew from the study because of adverse events. No incidence of virologic breakthrough was related to tenofovir DF resistance. Seven deaths occurred as a result of malignant disease.

“Treatment with tenofovir DF for up to 5 years is safe and well tolerated and maintains viral suppression in the majority of … patients with chronic hepatitis B,” the researchers concluded. “The findings of this study draw attention to the liver’s capacity for fibrosis regression, even when cirrhosis has developed, in hepatitis B when long-term viral suppression is attained. Moreover, the low frequency of adverse outcomes noted in this cohort reinforces the potential clinical benefits associated with regression of fibrosis, especially in patients with cirrhosis.”

Disclosure: See the study for a full list of relevant disclosures.