COHEN C, MOGYOROS M, SANDS M, LENTZ E, SIEMON-HRYCZYK P, PILSON R, DUFF F; Interscience Conference on Antimicrobial Agents and Chemotherapy.

Abstr Intersci Conf Antimicrob Agents Chemother Intersci Conf Antimicrob Agents Chemother. 1999 Sep 26-29; 39: 472 (abstract no. 508).

Community Res. Initiative, Brookline, MA

Background. Fortovase[TM] (Saquinavir) Soft Gel Capsules has been shown to be a potent protease inhibitor in combination regimens. The objective of this registration study is to compare the antiviral activity and safety of Fortovase[TM] TID + 2 nucleoside analogs (NAs) to that of FTV BID + 2 NAs or FTV BID + NFV BID + 1 NA in HIV-1 infected patients.METHODS: 840 antiretroviral naive or NA experienced patients with HIV RNA >/= 5000 c/mL were randomized to receive FTV 1200 mg TID (FTV TID; arm A), or FTV 1600 mg BID (FTV BID; arm B), each in combination with 2 NAs of choice, or FTV 1200 mg BID + NFV 1250 mg BID (FTV + NFV; arm C) + 1 NA of choice. Study duration is >/= 48 weeks.RESULTS: Baseline data for the first 670 patients enrolled: mean viral load = 4.8 log[10] c/mL, 4.7 log[10] c/mL, and 4.7 log[10] c/mL for arms A, B, and C, respectively (A, n=228; B, n=220; C, n=222); mean CD4 cell counts/micro- L = 306, 329, and 319 respectively. Intent to treat (ITT) analyses for this patient cohort at 24 weeks is: HIV RNA below level of quantification (BLQ), <400 c/mL by Amplicor[[TM]], FTV TID, 59%; FTV BID, 58%; FTV + NFV, 53%. On-treatment (OT) analyses at 24 weeks are: FTV TID (n = 167), 80% BLQ, 142/micro- L mean CD4 cell increase; FTV BID (n= 169), 76% BLQ, 137/micro- L mean CD4 cell increase; FTV + NFV (n= 152), 78% BLQ, 171/micro- L mean CD4 cell increase. OT analyses of patients completing 48 weeks are: HIV RNA (BLQ, <400 c/mL by Amplicor[[TM]]) FTV TID (n=79), 73% BLQ, 195/micro- L mean CD4 cell increase; FTV BID (n=69), 80% BLQ, 188/micro- L mean CD4 cell increase; FTV + NFV (n=69), 75% BLQ, 205/micro- L mean CD4 cell increase. All regimens are generally well tolerated and marked lab abnormalities were rare (<5%). The most frequently reported adverse events related to study drug in all arms are gastrointestinal.CONCLUSION: BID regimens containing FTV or FTV + NFV provide potent HIV suppression, tolerability and excellent safety. Preliminary data suggest that the BID regimens demonstrate durability at 48 weeks. Results from formal 24 weeks analysis will be presented on full patient cohort.

Publication Types:

• Meeting Abstracts

Keywords:

• Acquired Immunodeficiency Syndrome
• Anti-HIV Agents
• CD4 Lymphocyte Count
• Clinical Protocols
• HIV
• HIV Infections
• HIV Protease
• HIV Protease Inhibitors
• HIV Seropositivity
• HIV-1
• Humans
• Saquinavir
• Viral Load

Other ID:

• GWAIDS0008436

UI: 102245933

From Meeting Abstracts