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Yang W.,China Pharmaceutical University | Xiao Q.,China Pharmaceutical University | Wang D.,China Pharmaceutical University | Yao C.,Nanjing Frontier Biotechnologies Co. | Yang J.,China Pharmaceutical University
Xenobiotica | Year: 2016

1. A clinical study to assess the interactions between albuvirtide (320 mg) and lopinavir/ritonavir (400/100 mg) was conducted in 10 HIV-1-infected subjects. Because albuvirtide requires a long period to achieve steady state, and extended monotherapy may lead to early resistance, it is unethical to take albuvirtide alone to achieve steady state. Therefore, a population pharmacokinetic model was developed to predict steady-state concentration-time curve of solely administered albuvirtide. 2. When albuvirtide and lopinavir/ritonavir were co-administered, the plasma concentration of albuvirtide when the infusion ended (Cend) increased by about 34%, but the geometric mean ratios and 90% confidence intervals (90% CIs) of AUC(0– t ) [1.09 (0.96–1.24)] and Ctrough [1.00 (0.83–1.20)] were within the range of 0.8–1.25. For lopinavir, the ratios (90% CIs) of AUC(0– t ), Cmax and Ctrough were 0.63 (0.49–0.82), 0.67 (0.53–0.86) and 0.65 (0.46–0.91); for ritonavir, those ratios (90% CIs) were 0.62 (0.42–0.91), 0.61 (0.38–0.99) and 0.72 (0.40–1.26), respectively. 3. Co-administration of albuvirtide with lopinavir/ritonavir has little effect on albuvirtide exposure, but it decreases the plasma exposures of lopinavir/ritonavir. However, the drug–drug interactions may not reduce the effectiveness of this co-therapy, the trough concentration of lopinavir may be sufficient and this combination could achieve similar clinical efficacy with marketed drugs. So, a phase 3 clinical trial without dose adjustment is underway to validate their effectiveness and safety. © 2016 Informa UK Limited, trading as Taylor & Francis Group.

Zhang H.,Capital Medical University | Jin R.,Capital Medical University | Yao C.,Nanjing Frontier Biotechnologies Co. | Zhang T.,Capital Medical University | And 8 more authors.
AIDS Research and Therapy | Year: 2016

Background: Long acting antiretroviral drugs represent a promising approach for chronic treatment of HIV infection. Here, we study the efficacy and safety of albuvirtide (ABT), an HIV-1 fusion inhibitor with a half life of 11-12days in human. Methods: ABT was evaluated in a 7-week, open-label and randomized trial, combining with LPV/r. Twenty HIV-1-infected adults were assigned to two dose groups, receiving ABT (160 or 320mg) given weekly and LPV/r given twice daily. Results: At week 7, the decline of HIV-1 RNA from baseline was 1.9 (1.3-2.3) log10 and 2.2 (1.6-2.7) log10 copies/ml, and suppression of HIV-1 RNA to below 50 copies/ml was achieved in 11.1% (1/9) and 55.6% (5/9) patients, for the 160 and 320mg dose group respectively. Conclusion: A clear dose-efficacy correlation of ABT was demonstrated. ABT combining with LPV/r is a promising two-drug regimen to be tested in larger patient population. © 2016 Zhang et al.

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