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Conference
"A Summary of Two Talks Given during the ICAAC on the Ziagen Backbone" Dr. Jaime Hernandez (biography) English - 2003-09-24 - 18 minutes
(20 slides)
Summary : In this presentation we will do a review of the use of abacavir (ABC) as part of a nucleoside backbone. Previous studies like CLASS, NEAT and SOLO looked at ABC+3TC as the nucleoside backbone. Two new studies were presented at the ICAAC meeting in Chicago: CNA30024 (ABC vs ZDV with 3TC BID +EFV) and CNA30021 (ABC QD Vs ABC BID with 3TC/EFV QD).
Dr Edwin de Jesus presented the 48-week data from CNA30024, which showed similar virologic responses in the ABC and ZDV arms, and ABC showed a significantly greater median change in CD4+ from baseline (Oral presentation H-446).
The second study, CNA30021, also known as ZODIAC (Ziagen Once Daily in Anti-retroviral Combination therapy) was presented as a late breaker (H-1722b) by Dr Brian Gazzard. CBV-TP, the active moiety of ABC was shown to have a half life of more than 20 hours, thus making it suitable for once-daily dosing (ICAAC 2003 poster A-1797). From the CNA30021 study it was found that ABC/3TC/EFV is a viable once daily treatment option. Also, ABC QD is non-inferior to ABC BID when used with 3TC once daily plus EFV. ABC QD and BID had similar resistance and Adverse Event profiles, as well as incidence and presentation of HSR (ABC hypersensitivity).
Learning objectives : The participant will learn about the results of 2 new studies presented at the ICAAC 2003 meeting in Chicago, looking at abacavir (ABC) in the nucleoside backbone of the antiretroviral regimen:
Study CNA30024, presented by Dr Edwin de Jesus (Oral presentation H-446)
Conclusions:
- Virologic response ¡Ü 50 c/ml through Wk 48* confirms the non-inferiority of ABC/3TC/EFV compared to ZDV/3TC/EFV.
- CD4+ cell count response was significantly better in the ABC treatment group.
- No new or unusual safety concerns with the ABC treatment group.
- A triple drug regimen containing ABC, 3TC and EFV is associated with a potent and durable antiretroviral response.
*Using ITT Exposed, TLOVR Algorithm.
Study CNA30021 was presented as a late breaker (H-1722b) by Dr Brian Gazzard.
Conclusions:
- ABC/3TC/EFV is a viable once daily treatment option.
- ABC QD is non-inferior to ABC twice daily when used in combination with 3TC once daily plus EFV.
- ABC BID and QD had similar resistance profiles; most frequent mutation was single M184V/I
- The Adverse Event profile of ABC QD is similar to ABC BID.
- The incidence and presentation of HSR was similar when ABC was administered once daily or twice daily.
Bibliographic references : ICAAC 2003 Oral presentation H-446. DeJesus E et al. Abacavir BID Vs. Zidovudine BID in Combination with Lamivudine and Efavirenz in ART Naïve Subjects CNA30024: 48-Week Final Results.
ICAAC 2003 Late Breaker presentation H-1722b. Gazzard B.G. et al. Abacavir (ABC) Once Daily (OAD) Plus Lamivudine (3TC) OAD in Combination with Efavirenz (EFV) OAD is Well-Tolerated and Effective in the Treatment of Antiretroviral Therapy (ART) Naïve Adults with HIV-1 Infection (ZODIAC Study: CNA30021)
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