Neither branded nor generic lopinavir/ritonavir produces adequate lopinavir concentrations at a reduced dose of 200/50 mg twice daily.
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 <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.
The HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand. reshmie.r@hivnat.org
Reshmie A
RA
Ramautarsing
Jasper
J
van der Lugt
Meena
M
Gorowara
Jiratchaya
J
Wongsabut
Chuleeporn
C
Khongpetch
Praphan
P
Phanuphak
Jintanat
J
Ananworanich
Joep M A
JM
Lange
David M
DM
Burger
Kiat
K
Ruxrungtham
Anchalee
A
Avihingsanon
D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D006801:Humans; D061466:Lopinavir / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D019438:Ritonavir / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000627:therapeutic use; D013810:Therapeutic Equivalency
D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D061466:Lopinavir; D019438:Ritonavir