Comparison of the long-term efficacy of Tenofovir monotherapy versus Tenofovir and Phyllanthus Amari combination therapy: a randomized controlled trial

Abstract

Hepatitis B infection has become a social burden in over the world due to its high prevalence, while the treatments still do not offer the desired effects. Literature showed that combining traditional medicine with modern drugs was able to inhibit the proliferation of the hepatitis B virus, thus making it an effective treatment. To compare the efficacy of Tenofovir monotherapy versus Tenofovir and Phyllanthus Amari combination therapy in chronic hepatitis B patients. Randomized controlled clinical trial on 200 chronic hepatitis B patients with HBeAg (+); divided into 2 groups: The combination therapy group used Phyllanthus Amari product and Tenofovir for treatment and the monotherapy group with Tenofovir. The serological, biological, and virological responses in the combination therapy group were earlier than those in the monotherapy group. Statistically significant differences in serological responses between the combination therapy versus monotherapy group were achieved from the 3rd (59% versus 33%, p=0.021) to the 18th month (99% versus 91%, p=0.029). Statistically significant differences in biochemical responses between the combination therapy versus monotherapy group were achieved from the 9th (12% versus 1%, p=0.003) to the 18th month (35% versus 21%, p=0.040). Statistically significant differences in virological response between the combination therapy versus monotherapy group were achieved from the 6th (23% versus 10%, p=0.021) to the 18th month (97% versus 88%, p=0.029). The combination of Tenofovir and the Phyllanthus Amari product is more effective than using only Tenofovir for treatment in chronic hepatitis B patients with HBeAg-positive.