Long-term response after stopping tenofovir disoproxil fumarate in non-cirrhotic HBeAg-negative patients - FINITE study

- The potential to discontinue tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients was investigated.
- Of the patients who stopped TDF therapy, 62% remained off-therapy to Week 144.
- Four patients (19%) achieved HBsAg loss and three of them achieved HBsAg seroconversion.
- Discontinuing TDF therapy was well-tolerated.
- There is potential for HBsAg loss and/or sustained virological response in non-cirrhotic HBeAg-negative patients stopping long-term TDF therapy.

Background & AimsThere is currently no virological cure for chronic hepatitis B but successful nucleos(t)ide analogue (NA) therapy can suppress hepatitis B virus (HBV) DNA replication and, in some cases, result in HBsAg loss. Stopping NA therapy often leads to viral relapse and therefore life-long therapy is usually required. This study investigated the potential to discontinue tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients.MethodsNon-cirrhotic HBeAg-negative patients who had received TDF for ≥4 years, with suppressed HBV DNA for ≥3.5 years, were randomly assigned to either stop (n = 21) or continue (n = 21) TDF monotherapy. Standard laboratory tests including HBV DNA viral load, HBsAg and alanine aminotransferase (ALT) measurements, and adverse event reporting were carried out during treatment and post-treatment follow-up for 144 weeks.ResultsOf the patients who stopped TDF therapy, 62% (n = 13) remained off-therapy to Week 144. Median HBsAg change in this group was −0.59 log10 IU/ml (range −4.49 to 0.02 log10 IU/ml) vs. 0.21 log10 IU/ml in patients who continued TDF therapy. Four patients (19%) achieved HBsAg loss. Patients stopping therapy had initial fluctuations in viral load and ALT; however, at Week 144, 43% (n = 9) had either achieved HBsAg loss or had HBV DNA <2,000 IU/ml. There were no unexpected safety issues identified with stopping TDF therapy.ConclusionsThis controlled study demonstrated the potential for HBsAg loss and/or sustained virological response in non-cirrhotic HBeAg-negative patients stopping long-term TDF therapy.Lay summary: Nucleos(t)ide analogue (NA) is usually a life-long therapy for HBV patients. This randomised controlled study investigated the discontinuation of tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients. Of the patients who stopped TDF therapy, 62% remained off-therapy to Week 144, of which 43% of patients had achieved either HBsAg loss or HBV DNA <2,000 IU/ml. This offers a potential for long-term HBV-suppressed patients without cirrhosis to stop NA therapy under strict surveillance.Clinical trial number: NCT01320943.

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