Dòng Nội dung
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Comparison of the long-term efficacy of Tenofovir monotherapy versus Tenofovir and Phyllanthus Amari combination therapy : A randomized controlled trial / Huy Chung Ly, Bay Thi Nguyen, Nga Ngoc Cao, Duong Thai Nguyen, Sang Thanh Do // MedPharmRes . - 2023. - tr. 99-108. - ISSN: 2615-9139



Ký hiệu phân loại (DDC): 616.36
Introduction: 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. Materials and methods: 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. Results: 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 18 th 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). Conclusion: 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.
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Development and validation of a LC–MS/MS assay for tenofovir and tenofovir alafenamide in human plasma: Application in a bioequivalence study / Nai Ngoc Chuong, Nguyen Ho Nhat Nguyen, Hung Viet Tran, Tuan Duc Nguyen // MedPharmRes . - 2023. - tr. 32-41. - ISSN: 2615-9139



Ký hiệu phân loại (DDC): 615.19
Introduction: Tenofovir alafenamide (TAF), a prodrug of tenofovir (TFV), is currently used for treatment of chronic hepatitis B as first line recommendation. The Vietnamese market is currently circulating a tenofovir alafenamide generic. This formulation has not been assessed for in vivo bioequivalence. This study has been performed with the aim of development, validation, and application of LC-MS/MS procedure for quantitation of TAF and TFV in human plasma. Methods: Internal standard (IS), and analytical parameters were investigated to find out the suitable IS and conditions. Chromatographic conditions were optimized by considering the column type, mobile phase component, concentration of the buffer solutions and strength, oven temperature, flow rate, and injection volume. Human plasma samples were treated by protein precipitation with acetonitrile. The assay was validated in compliance with US-FDA and EMA guidelines. This assay was applied to evaluate the bioequivalence of the generic and reference products of 25 mg TAF in the healthy Vietnamese subjects under fed conditions. Results: TAF, TFV, IS were ionized using ESI and detected by MRM mode to obtain molecular and fragment ions for quantification. The recovery of all analytes from human plasma was above 70%. The chromatographic conditions contained a C6-Phenyl column and mobile phase including acetonitrile and 0.5% formic acid. The specificity, precision, accuracy, matrix effect of all the analytes were in the acceptable range. Thirty six subjects finished the fed trial. The two products’ geometric mean ratios for AUC0-t, AUC0-∞, and Cmax (80.00% to 125.00%) met the bioequivalence acceptance criteria. Conclusions: A LC-MS/MS procedure for simultaneous quantitation of TAF and TFV in human plasma was developed, validated, applied.
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