1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP
October 25 - 29, 2003 Warsaw, Poland
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9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP October 25 - 29, 2003 Warsaw, Poland |
| 7.3 Phase III/IV Trials F1/3 - EFFICACY AND SAFETY OF ONCE-DAILY LOPINAVIR/RITONAVIR VS. TWICE-DAILY LOPINAVIR/RITONAVIR IN ANTIRETROVIRAL-NAÏVE PATIENTS: 24-WEEK RESULTS |
| (1) Hospital de Bellvitge, Barcelona, Spain,2 Private Practice, Houston, TX, USA,3 Royal Free Hospital, London, UK,4 Private Practice, Fort Myers, FL, USA,5 Tan Tock Seng Hospital, Singapore,6 Abbott Laboratories, Abbott Park, IL USA |
Background of Study: In a pilot study, the safety, tolerability, and antiviral activity of a once-daily lopinavir/ritonavir (LPV/r)-based regimen appeared comparable to that of a twice-daily LPV/r-based regimen.
Methods: Study 418 is a randomized, open-label comparison of LPV/r 800/200 mg QD (n=115) vs. LPV/r 400/100 mg BID (n=75), each dosed with once-daily emtricitabine (FTC) and tenofovir DF (TDF).
Results: Median baseline viral load (VL) and CD4 count were 4.8 log10 copies/mL and 216 cells/mm3, respectively. Prior to Week 24, 15% (QD) and 12% (BID) patients discontinued, primarily due to adverse events (10% QD, 4% BID) or loss to follow-up or non-adherence (2% QD, 7% BID). Through 24 weeks, virologic responses were similar (see Table). The 95% CI for the difference in the Week 24 proportion of patients with HIV RNA <50 copies/mL (intent-to-treat) was (-14.3%, 14.4%). Mean increases in CD4 count from baseline to Week 24 were 129 (QD) and 103 (BID) cells/mm3 (p=0.164). Diarrhea (10% QD, 3% BID, p=0.05) and nausea (7% in each group) were the most common moderate or severe, study drug-related AEs. 81% and 79% of patients had maximum total cholesterol or triglycerides values of Grade 0-1 (<240 mg/dL and <400 mg/dL, respectively).
| Visit | Analysis (Proportion with HIV RNA <50 copies/mL) | QD | BID |
| Week 24 | Intent-to-treat, missing=failure | 66/115 (57%) | 43/75 (57%) |
| Week 24 | Observed data | 66/99 (67%) | 43/62 (69%) |
| Week 32 | Observed data (preliminary analysis based on 76 patients reaching Week 32 to date) | 37/45 (82%) | 25/31 (81%) |
Conclusions: Through 24 weeks, a QD regimen of TDF+FTC+LPV/r resulted in similar virologic responses in antiretroviral-naïve patients compared to the same regimen with LPV/r dosed BID. Both regimens were well tolerated, and diarrhea was the only AE reported more frequently in QD- vs. BID-treated patients.
Presenting Author: Dr. Daniel Podzamczer, Enfermedades Infecciosas Ciutat Sanitaria Bellvitge, L'Hospitalet de Llobregrat, Barcelona, Feixa Larga, s/n, 08907, Llobregat, Barcelona, Spain, Phone: +34-932607668
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