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Abstract 697. The Compact Quad, Combivir/Abacavir Efavirenz, (COM/ABC/EFV) Preliminary 48 Wk Results (COL30336)
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DM Parenti, George Washington University, Wash DC; Tower ID Medical assoc, LA, CA; D Margolis, VA Med Ctr, dallas; A Van Kempen, T Kauf, S Danehower, L Yau, s Hessenthaler, J Hernandez, GlaxoSmithKline.
Program abstract:
Background: Fewer than 50% of patients on 3-drug HAART regimens achieve HIV-RNA <50 copies/ml at 48 weeks. Implicated factors include regimen potency, pill burden and tolerability. CNAF3008, a previous study using the COM/ABC/EFV regimen showed improved efficacy at 48 wks; 90% of subjects achieved vRNA <50 c/ml using ITT, Switch Included analysis.
Methods: This ongoing, 48-wk, open-label trial studies the efficacy, safety, and adherence achieved with COM 1 tablet BID (twice daily), ABC 300mg BID and EFV 600mg QD (once daily) for 24 weeks, followed by Trizivir 1 tab BID and EFV for 24 weeks in ART-naive adults with vRNA >1000 c/ml. For those subjects who achieved vRNA <50 c/ml, the ultra-boosted assay (detection <3 c/ml) was performed. Enrollment is complete (38 subjects).
RESULTS: Of the 38 subjects enrolled, 87% are male, 39% are Caucasian, with a mean age of 39 yrs. Median baseline vRNA was 5.1 log (range 3.4-6.2) by PCR (66% had RNA >5 log); median baseline CD4 count was 285. Complete 24-wk and preliminary 32 and 48 week results are shown below. Median T-cell receptor excision circles (TRECs)/100,00 PBLs increased from 203 at baseline to 657 at week 24, indicating an increase in naive T cells. At week 24, 84% of subjects reported perfect adherence to all study drugs over the past week. 1/38 subjects reported an EFV-related serious adverse event and 3/38 experienced possible ABC hypersensitivity reactions.
Conclusions: In high RNA, ART-naive adults, the compact quad regimen of COM/ABC/EFV is potent, geneally well-tolerated and associated with good adherence.
Additional post conference report:
29 subjects completed 48 weeks of follow-up. Four experienced adverse drug events, one developed virologic failure, and 4 were lost to follow-up. Of the 29 subjects 5 underwent protocol-allowed drug substitution due to suspected ABC hypersensitivity, depression, or neutropenia. Mild adverse events were common, such as dreams (5), nausea (5), sleep disorders (3), and dizziness (3), among others; rash was not reported.
The report I read said at week 48, 26/38 (68%) had achieved such a viral load using conventional intent-to-treat analysis, 29/29 had HIV-RNA <400 c/ml using an observed analysis inclusive of drug switches. In turn 24/38 (63%) and 27/29 (93%) were found to have HIV-RNA <50 c/ml at week 48 using these respective analyses. The mean CD4 increase was from 285 to 438 by week 48 in the on-treatment group.
Under consideration by researchers & treaters is using a 4-drug regimen initially composed of Trizivir+EFV and after a period of time with <50 c/ml consider dropping the EFV.
Program preliminary data:
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