PURPOSE: 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. METHOD: 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. RESULTS: 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 Two patients were withdrawn with virologic failure but demonstrated no evidence of virologic resistance.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. CONCLUSION: 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.
PURPOSE: This study evaluated the safety and efficacy of switching HIV-infectedpatients with stable viral suppression on nonnucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) therapy to lopinavir/ritonavir (LPV/r) monotherapy. METHOD: 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. RESULTS: 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 Two patients were withdrawn with virologic failure but demonstrated no evidence of virologic resistance.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. CONCLUSION: 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.
Authors: Sanjay Pujari; Preeyaporn Srasuebkul; Somnuek Sungkanuparph; Poh Lian Lim; Nagalingeswaran Kumarasamy; John Chuah; Ritesh N Kumar; Yi-Ming A Chen; Shinichi Oka; Jun Yong Choi; Man-Po Lee; Praphan Phanuphak; Adeeba Kamarulzaman; Christopher Lee; Zhang Fujie; Rosanna Ditangco; Vonthanak Saphonn; Thira Sirisanthana; Tuti Parwati Merati; Jeff Smith; Matthew G Law Journal: J Antivir Antiretrovir Date: 2009-11-01
Authors: Bruce R Schackman; Callie A Scott; Paul E Sax; Elena Losina; Timothy J Wilkin; John E McKinnon; Susan Swindells; Milton C Weinstein; Kenneth A Freedberg Journal: Clin Infect Dis Date: 2007-09-04 Impact factor: 9.079
Authors: Timothy J Wilkin; John E McKinnon; A Gregory DiRienzo; Katie Mollan; Courtney V Fletcher; David M Margolis; Barbara Bastow; Gary Thal; William Woodward; Catherine Godfrey; Ann Wiegand; Frank Maldarelli; Sarah Palmer; John M Coffin; John W Mellors; Susan Swindells Journal: J Infect Dis Date: 2009-03-15 Impact factor: 5.226