In the GARDEL study comparing LPV/r+3TC with LPV plus two NRTIs the LPV/r+3TC regimen demonstrated non-inferiority at 48 weeks. However, because of the pill burden of LPV/r (3 pills taken twice daily), twice daily dosing, and higher rates of GI side effects compared to other PIs, the DHHS panel recommends that LPV/r plus 3TC be considered only in patients who cannot take TAF, TDF or ABC (Cahn 2014).
Efficacy in clinical trials:
- In the GARDEL study, 426 ART-naive patients were randomized to receive twice-daily LPV/r plus either open-label 3TC (twice daily) or two NRTIs selected by the study investigators. At 48 weeks, a similar number of patients in each arm had HIV RNA <50 copies/mL, meeting the study’s non-inferiority criteria. The LPV/r+3TC regimen was better tolerated than the LPV/r plus 2 NRTI regimen (Cahn 2014).
- Cahn P, Andrade-Villanueva J, Arribas JR, et al. Dual therapy with lopinavir and ritonavir plus lamivudine versus triple therapy with lopinavir and ritonavir plus two nucleoside reverse transcriptase inhibitors in antiretroviral-therapy-naïve adults with HIV-1 infection: 48 week results of the randomised, open label, non-inferiority GARDEL trial. Lancet Infect Dis. 2014;14(7):572-580. Available at PubMed.
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