Important note: Information in this article was accurate in May 2004. The state of the art may have changed since the publication date.
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AIDSWEEKLY Plus; Monday, May 31, 2004
Staff Medical Writers
"The safety, efficacy, and mutual interactions of combination amprenavir with lopinavir/ritonavir as deep salvage treatment were investigated in a prospective 24-week pilot study," scientists in Italy reported.
A. Deluca and colleagues explained, "HIV-infected patients (n = 22) with virologic failure to nucleoside reverse transcriptase inhibitors (NRTIs), non-NRTIs, and at least 2 protease inhibitors received 400/100 mg of lopinavir/ritonavir with 600 mg of amprenavir every 12 hours combined with NRTIs. Patients receiving the same doses of lopinavir/ritonavir (n = 10) or amprenavir with ritonavir (n = 8) were chosen as controls for pharmacokinetic analyses."
"Mean changes from baseline HIV RNA levels and CD4 counts after 24 weeks were -1.13 log10 copies/mL and +88 x 106 cells/L, respectively. The mean plasma trough concentration (Cmin) and peak concentration (Cmax) of amprenavir were 104% and 228% lower and the Cmin of lopinavir was 46% lower in patients in whom the drugs were coadministered than in controls. There were 4 permanent drug discontinuations because of toxicity," the authors reported.
"An inhibitory quotient (IQ) of amprenavir higher than 0.8 was the best predictor of virologic outcome at 24 weeks, even after adjusting for amprenavir Cmin or phenotypic susceptibility. Deep salvage therapy using lopinavir/ritonavir with amprenavir is sufficiently safe and shows partial efficacy. When these drugs are coadministered, therapeutic drug monitoring should be employed and the IQ can be used to determine target drug levels," concluded the investigators.
Deluca and colleagues published their study in Journal of Acquired Immune Deficiency Syndromes (Deep salvage with amprenavir and lopinavir/ritonavir - Correlation of pharmacokinetics and drug resistance with pharmacodynamics. J Acquir Immune Defic Syndr. 2004 Apr 20;35(4):359-366.
For additional information, contact A. Deluca, Istituto di Clinica delle Malattie Infettive, Universita Cattolica del Sacro Cuore, Largo F Vito 1, I-00168 Rome, Italy.
The publisher's contact information for the Journal of Acquired Immune Deficiency Syndromes is: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA.
The information in this article comes under the major subject areas of AIDS and HIV and Antiretroviral Therapy.
This article was prepared by AIDS Weekly editors from staff and other reports.
Reference
De Luca A, Baldini F, Cingolani A, et al., "Deep Salvage With Amprenavir and Lopinavir/Ritonavir: Correlation of Pharmacokinetics and Drug Resistance With Pharmacodynamics", J Acquir Immune Defic Syndr. 2004 Apr 20;35(4):359-366
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