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| |  NRTI-Sparing Regimen Noninferior to 3-Drug Regimen for Treatment-Naïve Patients With HIV: Presented at AIDS 2010 By Evelyn Harvey VIENNA -- July 20, 2010 -- Results presented here at the 18th International AIDS Conference show that lopinavir/ritonavir (LPV/r) and raltegravir (RAL) are safe and effective in treatment-naïve patients with HIV. The 48-week findings of the ongoing phase 3 M10-336 study (PROGRESS) were presented here on July 19 by Jacques Reynes, MD, Hôpital Gui de Chauliac, Montpellier, France. Many people living with HIV experience toxicity after prolonged treatment with standard nucleoside reverse transcriptase inhibitor (NRTI)-containing regimens. Therefore, researchers compared the effects of LPV/r plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) with an NRTI-sparing regimen containing LPV/r and RAL. Antiretroviral-naïve patients (HIV RNA viral load >1,000 copies/mL) were randomised to receive LPV/r 400/100 mg twice daily plus FTC/TDF 300/200 mg once daily (n = 105) or to LPV/r 400/100 mg twice daily with RAL 400 mg twice daily (n = 101). Baseline characteristics were similar between the 2 treatment groups. The primary efficacy endpoint was the proportion of subjects with plasma HIV-1 RNA <40 copies/mL at week 48, based on the US Food and Drug Administration (FDA) intent-to-treat, time-to-loss of virologic response (ITT-TLOVR) algorithm. At week 48, the primary efficacy endpoint was met in both groups. ITT-TLOVR analysis revealed that 83% of patients receiving RAL and 85% of patients receiving FTC/TDF had HIV-1 RNA <40 copies/mL. A significantly higher proportion of patients in the LPV/r plus RAL group achieved virological control between weeks 2 and 8 than in the NRTI regimen group (P < .001). The most common adverse events were diarrhoea and hyperlipidaemia, but the rates of all adverse events were similar across the 2 groups. Only 3 participants discontinued due to virological failure; this did not appear to be related to baseline viral load, resistance, or treatment group. Overall, 19 patients withdrew from the study before week 48. "The novel NRTI-sparing regimen of LPV/r + RAL is noninferior to a 3-drug antiviral regimen and shows similar tolerability," the authors wrote. "Therefore, a 2-drug NRTI-sparing regimen can provide an alternative approach for the treatment of ARV-naïve patients." Funding for this study was provided by Abbott. [Presentation title: Lopinavir/Ritonavir Combined With Raltegravir Demonstrated Similar Antiviral Efficacy and Safety as Lopinavir/Ritonavir Combined With Tenofovir Disoproxil Fumarate/Emtricitabine in Treatment-Naïve HIV-1 Infected Subjects (PROGRESS). Abstract MOAB0101]
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