This study evaluated the safety and efficacy of switching HIV-infected patients with stable viral suppression on nonnucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) therapy to lopinavir/ritonavir (LPV/r) monotherapy. Eligible patients discontinued NNRTI and started LPV/r. Two weeks later NRTIs were stopped and LPV/r monotherapy was continued. Patients were seen every 4 weeks throughout the 48-week study. Twelve of 18 (66%) participants met the primary endpoint with HIV RNA <75 copies/mL at week 48. Thirteen (72%) participants completed 48 weeks of LPV/r monotherapy, and 12 of 13 (92%) participants on treatment at week 48 had HIV RNA <75 copies/mL. Ten (55%) of 18 patients maintained HIV RNA <75 copies/mL at all time points. Two patients were withdrawn with virologic failure but demonstrated no evidence of virologic resistance. Three (17%) patients withdrew due to diarrhea, 2 with hyperglycemia at baseline developed diabetes mellitus, 7 (54%) required addition of or increase in lipid-lowering agents, but none had grade 3 or 4 hyperlipidemia. Results from this pilot study suggest that LPV/r monotherapy may be an option for management of HIV infection. Larger, randomized trials are warranted to evaluate the safety, efficacy, and patient population who might benefit from LPV/r monotherapy.

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