AIDSWEEKLY Plus; Monday, November 24, 2003
Staff Medical Writers

The U.S. Food and Drug Administration granted marketing clearance for Lexiva on October 20, 2003.

Approximately two-thirds of the patients in this trial had fasting cholesterol levels measured at the onset of the study and at 48 weeks. A total of 232 patients in the Lexiva/r study arm and 245 patients in the nelfinavir (NFV) arm were included in the cholesterol study presented at EAC.

At baseline, the mean HDL-C level was 38 mg/dL among all patients taking Lexiva and 37 mg/dL among NFV patients. Further, 60% of subjects taking Lexiva/r and 68% taking NFV had low HDL-C concentrations of less than 40 mg/dL. This cut-off is based on National Cholesterol Education Program guidelines.

At 48 weeks, the mean HDL-C level among all patients increased to 46 mg/dL (a 29% increase in the Lexiva arm, and a 27% increase in the NFV arm). Further, HDL-C had risen to above 40 mg/dL in 76% of patients with low HDL-C (<40mg/dL) in the Lexiva/r arm and 69% in the NFV arm. The proportion of patients with HDL-C levels greater than 60 mg/dL increased from 4-15% among patients taking Lexiva/r, and from 4-18% among patients taking NFV.

Lexiva was codiscovered by GlaxoSmithKline and Vertex Pharmaceuticals (VRTX) and is indicated for the treatment of HIV infection in adults in combination with other antiretroviral agents. Lexiva, a PI that can be taken once or twice daily without food or water restrictions, has been evaluated in clinical trials with both PI-experienced and antiretroviral therapy- (ART) naive HIV patients.

"These results supplement the body of existing data regarding the safety and efficacy of Lexiva boosted with ritonavir," said Doug Manion, MD, vice president of clinical development and medical affairs at GSK.

The results are from the SOLO study of treatment-naive HIV patients in which 322 subjects took once-daily (QD) Lexiva/r and a second group of 327 patients took the PI nelfinavir (NFV) twice daily (BID). In both treatment arms, the PIs were administered as part of a regimen that also included abacavir and lamivudine dosed BID.

Also at the European AIDS Council meeting, GSK presented poster #10.1/18 regarding resistance data from the SOLO study in which virus from patients treated with Lexiva/r had no PRO mutations and significantly less RT mutation at virologic failure. The clinical relevance of resistance data is currently under evaluation.

Another poster presented in Warsaw assessed liver enzyme changes over 48 weeks of treatment with Lexiva/r QD, and nelfinavir in HIV-infected ART-naive adults with HBV and/or HCV co-infection enrolled in the SOLO trial. Overall, for patients co-infected with HBV and/or HCV, hepatotoxicity was limited and comparable between the Lexiva/r QD and nelfinavir BID groups.

Lexiva is primarily metabolized by the liver; therefore, caution should be exercised when administering Lexiva to patients with hepatic impairment because amprenavir concentrations may be increased. Patients with underlying hepatitis B or C or marked elevations in transaminase prior to treatment may be at increased risk for developing transaminase elevations and appropriate laboratory testing should be conducted prior to initiating therapy with Lexiva and patients should be monitored closely during treatment.

Lexiva is a new protease inhibitor indicated for the treatment of HIV infection in adults in combination with other antiretroviral medications.

GSK will market Lexiva and GSK and Vertex will copromote it in the United States and key markets in Europe.

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

Reference

Horban A., Staszewski S., Walmsley S., et al., "F8/3 - Favourable increases in high-density lipoprotein cholesterol (HDL-C) concentrations in chronic HIV-infected therapy naïve subjects receiving 908/R QD in the SOLO study", European AIDS Conf 2003 Oct 25-29;9:(abstract no. 41).

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