Important note: Information in this article was accurate in July 2004. The state of the art July have changed since the publication date.
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AIDSWEEKLY Plus; Monday, July 26, 2004
Staff Medical Writers
Both regimens were generally well tolerated, according to the study's authors. Lexiva (formerly GW433908, or 908), the first PI to combine flexible dosing (QD or BID) in PI-naive patients with no food or water restrictions, was approved by the U.S. Food and Drug Administration (FDA) in October 2003.
Co-discovered by GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (VRTX), Lexiva is indicated in combination with other antiretroviral agents for the treatment of HIV infection in adults.
The following points should be considered when initiating therapy with Lexiva/r in PI-experienced patients: the PI-experienced patient study was not large enough to reach a definitive conclusion that Lexiva/r and lopinavir/ritonavir are clinically equivalent. Once-daily administration of Lexiva plus ritonavir is not recommended for PI-experienced patients.
SOLO, an international open-label, multicenter study, evaluated the safety and efficacy of Lexiva/r QD versus NFV BID, in 649 therapy-naive patients with HIV infection. Patients were randomized to take either two 700mg Lexiva tablets plus two 100mg ritonavir capsules QD (four pills daily) with no food or water restrictions, or five 250mg nelfinavir tablets BID (10 pills daily) with a meal.
All patients also received the nucleoside reverse transcriptase inhibitors abacavir (ABC) and lamivudine (3TC) BID.
"In clinical trials, Lexiva has been shown to be an effective and well- tolerated PI. Lexiva also offers flexible dosing regimens, with a low pill burden and options for once- or twice-daily dosing in PI-naive patients. Lexiva underscores GSK's commitment to provide state-of-the-art antiretroviral therapies for patients," said Doug Manion, MD, vice president of HIV clinical development and medical affairs at GSK.
In the analysis of data from the SOLO trial reported in AIDS, 69% of patients taking Lexiva/r QD and 68% taking NFV BID had viral levels below 400 copies/mL at 48 weeks.
SOLO enrolled 649 therapy-naive, ethnic- and gender-diverse patients with HIV (median viral RNA levels were 4.8 log10 copies/mL; median CD4+ counts 170/mm3). Twenty% of patients entered the SOLO trial with CD4+ cell counts below 50 cells/mm3 and 22% had a history of CDC Class C events, (i.e., patient had experienced an opportunistic infection). Baseline characteristics were similar between the two groups.
More than 1200 people - both ART-naive and PI-experienced patients - participated in three phase III multicenter trials, including SOLO, to test the safety and efficacy of Lexiva with and without ritonavir. In all three trials, study drugs were taken as part of combination therapy that included two NRTIs.
Lexiva is approved for dosing in therapy-naive patients in one of three ways: 1) two 700mg tablets BID; 2) two 700mg tablets in combination with two 100mg ritonavir capsules QD; or 3) one 700mg tablet in combination with one 100mg ritonavir capsule BID. For PI-experienced patients, the recommended dose is one 700mg tablet BID in combination with one 100mg capsule of ritonavir BID.
This article was prepared by AIDS Weekly editors from staff and other reports.
Reference
Gathe JC Jr, Ive P, Wood R, et al., "SOLO: 48-week efficacy and safety comparison of once-daily fosamprenavir /ritonavir versus twice-daily nelfinavir in naive HIV-1-infected patients", AIDS. 2004 Jul 23;18(11):1529-1537.
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