Neither Branded Nor Generic Lopinavir/Ritonavir Produces Adequate Lopinavir Concentrations at a Reduced Dose of 200/50 mg Twice Daily

作者：Ramautarsing Reshmie A^*; van der Lugt Jasper; Gorowara Meena; Wongsabut Jiratchaya; Khongpetch Chulee****; Phanuphak Praphan; Ananworanich Jintanat; Lange Joep M A; Burger David M; Ruxrungtham Kiat; Avihingsanon Anchalee

来源：JAIDS: Journal of Acquired Immune Deficiency Syndromes , 2012, 59(1): 55-58.

DOI：10.1097/QAI.0b013e31823ba736

• clinical pharmacology
• dose reduction
• generics
• HIV
• Thailand

We assessed pharmacokinetic (PK) parameters of reduced dose lopinavir/ritonavir (LPV/r) and compared generic and branded tablets. Twenty HIV-infected patients using protease inhibitors with HIV RNA %26lt;50 copies per milliliter were randomized to generic or branded LPV/r 200/50mg twice daily (BID). At week 2, PK-sampling was performed. Patients crossed over to the other arm until week 12, with another PK-sampling at week 4. Subtherapeutic lopinavir concentrations were observed in 10/40 samples. PK parameters were comparable between branded and generic tablets. All patients remained virologically suppressed at week 12. In conclusion, LPV/r 200/50mg BID does not lead to adequate lopinavir plasma concentrations. Generic and branded LPV/r have comparable PK-parameters.

• 出版日期2012-1-1