AIDSWEEKLY Plus; Monday, May 11, 2009
Staff Medical Writers

2009 MAY 11 - (NewsRx.com) -- "Lopinavir/ritonavir (LPV/r)-dosed twice daily has demonstrated durable efficacy in antiretroviral-naive and protease inhibitor (PI) -experienced patients. M05-730 compared LPV/r tablets dosed once daily vs. twice daily in antiretroviral-naive subjects," researchers in the United States report (see also HIV/AIDS).

"Six hundred sixty-four subjects were randomized to LPV/r soft gel capsules (SGCs) once daily, SGC twice daily, tablets once daily, and tablets twice daily, all with tenofovir and emtricitabine once daily. At week 8, all SGC-treated Subjects were switched to tablets, maintaining randomized dose frequency. The primary efficacy analysis used an intent-to-treat, noncompleter = failure approach to assess noninferiority of the LPV/r once-daily group compared with the twice-daily group. At week 48, 77% of once-daily-dosed subjects vs. 76% of twice-daily-dosed subjects had HIV-1 RNA <50 copies per milliliter (P = 0.715; 95% confidence interval for difference: 5% to 8%). Response rates were numerically similar between the once-daily and twice-daily groups among subjects with baseline HIV-1 RNA >= 100,000 copies per milliliter (75% once daily vs. 74.6% twice daily; P> 0.999) or when analyzed by baseline CD4(+) T-cell count (<50, 50 to <200, and >= 200 cells/mm(3)). Rates of discontinuation and adverse events, including diarrhea, were similar between arms. Among subjects with protocol-defined virologic rebound through week 48, no new PI resistance mutations were detected. At 48 weeks, the antiviral response in the LPV/r once-daily group was noninferior to the twice-daily group when coadministered with tenofovir and emtricitabine in antiretroviral-naive subjects. Efficacy was comparable between the once-daily and twice-daily groups regardless of baseline HIV-1 RNA or CD4(+) T-cell count. Safety and tolerability of once-daily and twice-daily dosing was also comparable," wrote J. Gathe and colleagues.

The researchers concluded: "No new PI resistance mutations were detected upon virologic rebound."

Gathe and colleagues published their study in Jaids - Journal of Acquired Immune Deficiency Syndromes (A Once-Daily Lopinavir/Ritonavir-Based Regimen Is Noninferior to Twice-Daily Dosing and Results in Similar Safety and Tolerability in Antiretroviral-Naive Subjects Through 48 Weeks. JAIDS - J Acquir Immune Defic Syndr. 2009 Apr 15;50(5):474-81).

For additional information, contact J. Gathe, Abbott Laboratories, Antiviral Clinic Team, 200 Abbott Pk Rd., Dept. of R48U, Bldg AP30-3, Abbott Park, IL 60064, USA.

Publisher contact information for the Jaids - Journal of Acquired Immune Deficiency Syndromes is: Lippincott Williams & Wilkins, 530 Walnut St., Philadelphia, PA 19106-3621, USA.

Keywords: United States, HIV/AIDS, AIDS, Acquired Immune Deficiency Syndrome, Acquired Immunodeficiency Syndrome, Anti-HIV, Antivirals, Biotechnology Business, Biotechnology Company, Drugs, Emtricitabine, Enzymology, HIV, Human Immunodeficiency Virus, Immunology, Nucleoside and Nucleotide Reverse Transcriptase InhibitorsAntiretroviral, Pharmaceuticals, Protease Inhibitor, Protease Inhibitors, Ritonavir, Sexually Transmitted Disease, Tenofovir, Therapy, Treatment, ViroLogic Inc., Virology.

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

2009-05-11
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