HIV/AIDS HAART: Fosamprenavir-ritonavir similar in safety and efficacy as lopinavir-ritonavir in HIV/AIDS

AIDSWEEKLY Plus; Monday, October 2, 2006
Staff Medical Writers

According to a recently published study from the United States, "Lopinavir-ritonavir is a preferred protease inhibitor coformulation for initial HIV-1 treatment. Fosamprenavir-ritonavir has shown similar efficacy and safety to lopinavir-ritonavir when each is combined with two nucleoside reverse transcriptase inhibitors.

"We compared the two treatments directly in antiretroviral-naive patients. This open-label, noninferiority study included 878 antiretroviral-naive, HIV-1-infected patients randomised to receive either fosamprenavir-ritonavir 700 mg/100 mg twice daily or lopinavir-ritonavir 400 mg/100 mg twice daily, each with the coformulation of abacavir-lamivudine 600 mg/300 mg once daily."

"Primary endpoints were proportion of patients achieving HIV-1 RNA less than 400 copies per mL at week 48 and treatment discontinuations because of an adverse event. The intent-to-treat analysis included all patients exposed to at least one dose of randomized study medication. This study is registered with ClinicalTrials.gov, number NCT00085943," investigators said.

"At week 48," reported E. Joseph and colleagues at the University of North Carolina, "noninferiority of fosamprenavir-ritonavir to lopinavir-ritonavir (95% CI around the treatment difference -4.84 to 7.05) was shown, with 315 of 434 (73%) patients in the fosamprenavir-ritonavir group and 317 of 444 (71%) in the lopinavir-ritonavir group achieving HIV-1 RNA less than 400 copies per mL."

"Treatment discontinuations due to an adverse event were few and occurred with similar frequency in the two treatment groups (fosamprenavir-ritonavir 53, 12%; lopinavir-ritonavir 43, 10%). Diarrhea, nausea, and abacavir hypersensitivity were the most frequent drug-related grade 2-4 adverse events.

"Treatment-emergent drug resistance was rare; no patient had virus that developed reduced susceptibility to fosamprenavir-ritonavir or lopinavir-ritonavir," continued Joseph.

The authors concluded, "Fosamprenavir-ritonavir twice daily in treatment-naive patients provides similar antiviral efficacy, safety, tolerability, and emergence of resistance as lopinavir-ritonavir, each in combination with abacavir-lamivudine."

Joseph and colleagues published their study in Lancet (The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised noninferiority trial. Lancet. 2006 Aug 5;368(9534):476-82).

For more information, contact E. Joseph, University of North Carolina, Dept. of Medical, Division Infectious Disease, Chapel Hill, NC 27599, USA.

Publisher contact information for the journal Lancet is: Lancet Ltd., 84 Theobalds Rd., London WC1X 8RR, England.

Keywords: Chapel Hill, North Carolina, United States, HIV/AIDS, Drug Resistance, Lopinavir-Ritonavir, Fosamprenavir-Ritonavir.

This article was prepared by AIDS Weekly editors from staff and other reports.

Reference

Eron J Jr, Yeni P, Gathe J Jr, et al., “The KLEAN study of fosamprenavir-ritonavir versus lopinavir-ritonavir, each in combination with abacavir-lamivudine, for initial treatment of HIV infection over 48 weeks: a randomised non-inferiority trial”, Lancet. 2006 Aug 5;368(9534):476-82.

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