Novel tenofovir formulation noninferior to disoproxil fumarate in chronic hepatitis B

In the treatment of patients with chronic hepatitis B (CHB), the novel tenofovir amibufenamide (TMF) is as good as tenofovir disoproxil fumarate (TDF) in terms of efficacy but with the advantage of better bone and renal safety, according to the results of a noninferiority trial.

A total of 1,002 CHB patients (median age 35 years, 72.1 percent male) were randomized to receive 25-mg TMF, 300-mg TDF, or matching placebo. The median levels of hepatitis B virus (HBV) DNA at baseline were about 7.92 log₁₀ IU/mL for the HBeAg-positive patients and 5.78 log₁₀ IU/mL for the HBeAg-negative patients.

Genotype C (55.8 percent) was the most common HBV genotype, followed by genotype B (42.7 percent). The median alanine transaminase ALT level at baseline was 103.35 U/L for HBeAg-positive patients and 84.8 U/L for HBeAg-negative patients.

After a median 48 weeks of treatment, the noninferiority criterion was met in all analysis sets. In the HBeAg-positive group, 50.2 percent of patients on TMF and 53.7 percent of those on TDF achieved HBV DNA less <20 IU/mL. The corresponding number of patients in the HBeAg-negative population who achieved this outcome was 88.9 percent and 87.8 percent in the TMF and TDF groups, respectively.

Meanwhile, patients on TMF showed a significantly lower decrease in bone mineral density at both hip (p<0.001) and spine (p<0.001), as well as a smaller rise in serum creatinine at week 48 (p<0.05). Other safety results were similar across treatment groups.

The findings suggest the potential utility of TMF 25 mg once daily in the treatment of adult patients with HBeAg-positive or -negative chronic HBV.