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Durable and Consistent Efficacy of Raltegravir (RAL) With Tenofovir (TDF) and Emtricitabine (FTC) Across Demographic and Baseline Prognostic Factors In Treatment-naïve Patients (pts) From STARTMRK at Wk 156
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Reported by Jules Levin
ICAAC Sept 17-20 2011 Chicago
A. Lazzarin1, E. DeJesus2, J. K. Rockstroh3, J. Lennox4, M. Saag5, H. Wan6, A. Rodgers6, M. J. DiNubile6, B-Y. Nguyen6, R. Leavitt6, H. Teppler6, and P. Sklar6 for the STARTMRK Study Team
1Universitā Vita-Salute San Raffaele, Milan, Italy; 2Orlando Immunology Center, Orlando, FL, USA; 3Oberarzt an der Medizinischen Universitätsklinik, Bonn, Germany; 4Emory University, Atlanta, GA, USA; 5University of Alabama at Birmingham, USA; 6Merck Research Laboratories, North Wales, PA, USA
ABSTRACT
Background: In treatment-naive pts given 156 wks of combination therapy with TDF/FTC, RAL was non-inferior in efficacy compared to efavirenz (EFV). Here we present the Wk 156 subgroup analyses.
Methods: Previously untreated pts without resistance to EFV, TDF or FTC were eligible for a blinded randomized study of TDF/FTC plus either RAL (400 mg bid) or EFV (600 mg qhs). In exploratory subgroup analyses using an observed-failure approach to missing data (whereby only data from pts discontinuing due to lack of efficacy were carried forward), % pts with vRNA <50 c/mL & change from baseline CD4 counts at Wk 156 were summarized by treatment group within prespecified baseline (BL) subpopulations to assess the consistency of the overall results.
Results: For Wk 156 analyses, 237/281 (84%) RAL & 227/282 (80%) EFV recipients with a median age of 37 yrs at entry were evaluable. Only 5 (1.8%) & 7 (2.5%) of treated pts in the respective RAL & EFV groups had discontinued by Wk 156 due to lack of efficacy. Rates of vRNA suppression <50 c/mL at Wk 156 with RAL or EFV were generally consistent across demographic & BL prognostic variables:
Conclusion: For both RAL & EFV groups at Wk 156, consistent virologic & immunologic efficacy was maintained across gender, age, race, BL vRNA level, BL CD4-cell count, HIV-1 subtype, & hepatitis co-infection.
Methods
Screening plasma vRNA level (≤ 50,000 copies/mL; >50,000 copies/mL) and hepatitis status were both stratification factors. Median ages at entry were 37 years for the RAL group and 36 years for the EFV groups. The viral subtype was missing in 3 RAL recipients and 5 EFV recipients.
One patient in the EFV group with missing results was excluded.
Hepatitis B surface antigen positivity or detectable hepatitis C RNA.
Non-clade B subtypes (number of patients): clade A (4), A/C (1), A/G (2), A1(1), AE (29), AG (12), BF (6), C (37), D (2), F (2), F1 (5), G (2), and Complex (3).
N = Number of patients in each group; n (%) = number (percent) of patients in each category.
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