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A Novel Use of Abacavir to Simplify Therapy in PI Experienced Patients Successfully Treated with HAART: CNA30017 F. GOEBEL* and R. K. WALLI for the CNA30017 Study Team.
Ludwig-Maximilians Univ., Munich, Germany Background: Although PI-containing HAART regimens have proven efficacious, many patients have difficulty tolerating the complex treatment combinations and long-term side effects. Well tolerated, compact ART regimens are therefore required to improve the choice of potential treatment options for HIV infection.
Objectives: To compare efficacy/safety of switching to an ABC-containing triple NRTI regimen versus continued therapy with the current standard of care (2 NRTI +PI). In addition, to evaluate the effect of switching on insulin sensitivity (IS) and serum lipids (fasting) in a sub-group of patients enrolled in this study.
Design: Randomised, open-label trial in 211 adults over 48 weeks. Eligible patients had plasma HIV-1 RNA <50 c/ml at screening and no virological failure since initiation of ART. Patients were randomised to either remain on current 2NRTI/PI therapy or replace PI with ABC. Primary study endpoint was treatment failure (vRNA >400 c/ml on 2 consecutive occasions or premature discontinuation of study treatment). IS and fasting lipids were measured at baseline and week 24.
Results: 105 patients were randomised to ABC and 106 to continue on their 2NRTI/PI regimen. Following 24 weeks, 7 patients on ABC and 11 continuing on PI had experienced treatment failure (ITT exposed). 2 patients in each group experienced virological failure >400 c/ml. In the ABC group there was evidence of reduction in triglyceride (TG) and cholesterol (CHOL) levels, and also reversal of insulin resistance. 6 serious adverse events were reported, 2 of which were ABC hypersensitivity reactions.
Conclusion: Preliminary 24 week data indicate sustained virological suppression following a switch from PI-based HAART regimens to a simplified triple NRTI combination containing ABC, with the additional benefits of a trend in lower TG/CHOL levels and an improvement in IS.
Key Words: Class Preserving, Triple NRTI
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