A pilot study of abacavir/lamivudine and raltegravir in antiretroviral-naïve HIV-1-infected patients: 48-week results of the SHIELD trial.
OBJECTIVE
to evaluate raltegravir plus abacavir/lamivudine in antiretroviral-naïve, HIV-1-infected patients.


METHODS
SHIELD is an ongoing 96-week pilot study of abacavir/lamivudine 600 mg/300 mg once daily with raltegravir 400 mg twice daily among HLA-B*5701-negative adults with screening viral load (VL) > 1,000 copies/mL. HBsAg+ patients were excluded, as were patients with key mutation(s) to any study drug. Virologic failure (VF) was defined as either VL > 400 copies/mL at week 24 or confirmed virologic rebound.


RESULTS
thirty-five patients enrolled (mean age 38.7 years). Most were white males, but 26% self-identified as Hispanic/Latino. At baseline, 34% had VL ≥ 100,000 copies/mL (median, 4.8 log10 copies/mL) and 20% had CD4 cell counts <200 cells/mm3 (median, 301). One patient discontinued due to adverse events (AEs); one patient experienced VF. At week 48, 91% (32/35) had VL <50 and <400 copies/mL by missing/discontinuation equals failure analysis. Median CD4 cell count change from baseline was +247 cells/mm3. Five patients (14%) had treatment-related grade 2-4 AEs; no treatment-related serious AEs were reported. Over 48 weeks, median fasting lipids increased for total (+17%), LDL (+9%), and HDL (+6%) cholesterol but remained stable for triglycerides (-1%) and total:HDL cholesterol ratio (0%).


CONCLUSIONS
in this pilot study, abacavir/lamivudine plus raltegravir was effective and generally well-tolerated over 48 weeks with modest changes in fasting lipids.
Rocky Mountain CARES, Denver, Colorado, USA Health Connections International, Amsterdam, The Netherlands. byoung@rockymountaincares.org
Benjamin
B
Young
Thanes
T
Vanig
Edwin
E
Dejesus
Trevor
T
Hawkins
Marty
M
St Clair
Linda
L
Yau
Belinda
B
Ha
Shield Study Team
D000328:Adult; D002097:C-Reactive Protein / Q000378:metabolism; D018791:CD4 Lymphocyte Count; D002784:Cholesterol / Q000097:blood; D015224:Dideoxynucleosides / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1; D006801:Humans; D015850:Interleukin-6 / Q000097:blood; D019259:Lamivudine / Q000008:administration & dosage*; D008297:Male; D010865:Pilot Projects; D011446:Prospective Studies; D011760:Pyrrolidinones / Q000008:administration & dosage*; D012367:RNA, Viral / Q000097:blood; D000068898:Raltegravir Potassium; D014280:Triglycerides / Q000097:blood; D000099227:Abacavir
D002097:C-Reactive Protein; D002784:Cholesterol; D015224:Dideoxynucleosides; D004338:Drug Combinations; D015850:Interleukin-6; D019259:Lamivudine; D011760:Pyrrolidinones; D012367:RNA, Viral; D000068898:Raltegravir Potassium; D014280:Triglycerides; C492871:abacavir, lamivudine drug combination; D000099227:Abacavir