Effectiveness and Safety of Low Dose of Tenofovir Disoproxil Fumarate in Malagasy Patients with Chronic Hepatitis B.

BACKGROUND

Accessibility of full dose daily of tenofovir disoproxil fumarate (TDF) is limited in Madagascar with an estimated cost well above the purchasing power of Malagasy population.

OBJECTIVE

The study is aimed at evaluating the efficacy and safety of low-dose tenofovir for the treatment of chronic hepatitis B (CHB).

METHODS

This prospective cohort study from January 2018 to December 2020 was conducted in the Department of Hepato-Gastroenterology, University Hospital Joseph Raseta Befelatanana, Antananarivo, Madagascar. The patients enrolled in the study received low dose of TDF 900 mg/week (300 mg daily, three days per week).

RESULTS

A total of 45 patients (male/female: 31/14) were included. The mean age was 45.1 ± 11.5 years. Fifteen patients were nucleos(t)ide (NA)-naïve, and 30 patients had prior NA therapy (NA-experienced). Thirty patients were HBeAg positive. A complete virological response (CVR) was achieved in 36/45 patients (80%) at 3 months, 41/45 (91.1%) at 6 months, and 43/45 (95.6%) at 12 months. High viral load at baseline was negative predictive factor of CVR at 3 months (HR: 0.14; 95% CI: 0.022-0.92; p: 0.041). There was no significant difference in response between HBeAg-positive and HBeAg-negative patients, NA-naïve and NA-experienced patients, and cirrhotic and noncirrhotic patients. Low dose of tenofovir was well tolerated. Ten patients (22.22%) had mild side effects. Mild renal failure was observed in 3 patients (6.7%) during follow-up.

CONCLUSION

Low dose of tenofovir is effective, safe, and well tolerated in a Malagasy population sample. These results still require verification in a large population.