Meta-Analysis of Once-Daily and Twice-Daily Lopinavir/Ritonavir Combined with NRTIs in HIV-1-Infected, Antiretroviral-Naive Patients

• Published in: Future virology Vol. 7; no. 1; pp. 103 - 113
• Main Authors: van Wyk, Jean, Qaqish, Roula, Hollar, Kimberly, White, Kelly, D‘Amico, Ronald, Norton, Michael, Chiu, Yi-Lin, King, Martin
• Format: Journal Article
• Language: English
• Published: London Future Medicine Ltd 01.01.2012
• Subjects: Acquired immune deficiency syndrome; AIDS; Anti-HIV agents; Antiretroviral drugs; Antiviral agents; Biological products industry; CD4 antigen; Clinical trials; Drug therapy; HIV; HIV (Viruses); HIV infection; Human immunodeficiency virus; Human immunodeficiency virus 1; Hypertriglyceridemia; Lopinavir; Lymphocytes T; Mutation; Pharmaceutical industry; Pharmacodynamics; Pharmacokinetics; Reviews; Ritonavir; RNA; Studies; T cells; United States
• ISSN: 1746-0794; 1746-0808
• DOI: 10.2217/fvl.11.127

Aims: Several studies reported similar virologic responses for lopinavir/ritonavir (LPV/r) 800/200 mg once-daily (q.d.)-containing regimens or LPV/r 400/100 mg twice-daily (b.i.d.)-containing regimens in antiretroviral-naive patients. However, the virologic response in patients with baseline viral loads [greater than or equal]100,000 copies/ml and gastrointestinal adverse events (AEs) sometimes favored b.i.d. dosing, whereas hypertriglyceridemia may be less frequent with q.d. dosing. This meta-analysis compared the efficacy and tolerability of these two dosing strategies. Materials & methods: Random effects meta-analysis models, in all patients and subgroups with baseline plasma HIV-1 RNA [greater than or equal]100,000 copies/ml and CD4.sup.+ T-cell counts <200 cells/µl, assessed virologic efficacy (HIV-1 RNA <50 copies/ml and time to virologic failure) and prespecified AEs incidence between q.d. and b.i.d. dosing strategies. Descriptive analysis of the pharmacokinetic/pharmacodynamic relationship and resistance development was performed. Results: No difference was found between the two strategies in virologic efficacy, to virologic failure, or AEs in the overall or subgroup populations. Numerical but nonstatistically significant differences in discontinuations due to AEs (2.4%; 95% CI: -0.7-5.5; p = 0.132) favored b.i.d. over q.d. dosing in the overall population. Conclusion: Virologic efficacy, treatment durability and tolerability were similar between the two dosing strategies in the overall and subgroup populations. The LPV/r dosing strategy should be individualized according to patient need.