Table 5 Effectiveness of abacavir/lamivudine and efavirenz (viral load non-detectable and increase in median of CD4) in HIV naive patients 18 years or older, compared with six other HIV/AIDS drug treatment studies
Type of study | Patients (n) | % of patients with viral load <50 copies/mL | Median CD4+ cell count increases [cells/mm3] | Commentary | |
|---|---|---|---|---|---|
Intention-to-treat analysis | On-treatment analysis | ||||
Nonrandomized, open-label, phase IV study (Current Study, viral load <40 copies/mL)) | 42 | 73.8 | 93.9 | 172 | HLA-B*57 allele negative. 91.2 % patients with viral load <40 copies/mL, in intention-to-treat analysis; Failure |
Open-label, multicenter, randomized trial of up to 3 consecutive treatment regimens over 96 weeks in 291 subjects received abacavir/lamivudine and efavirenz, ritonavir-boosted amprenavir, or stavudine (CLASS Study) [29] | 291 | 75 (estimated values from figure 3C at 48 week) | 91 (64 of 70 patients received abacavir/lamivudine and efavirenz) | 194 | HLA-B*5701 genotype test was not screening. Results included patients with viral load <100.000 or > 100.000 copies/mL |
Multicenter, randomized, double-blind no inferiority clinical trial of abacavir with zidovudine plus lamivudine and efavirenz (CNA30024 Study) [30] | 324 | 71.7 (142 of 198 patients with viral load <100.000 copies/mL) | 89.3 % (226 of 253 patients with viral load <100.000 or > 100.000 copies/mL) | 209 | HLA-B*5701 genotype test was not screening. |
Randomized, open-label, multicenter study of abacavir/lamivudine administered with tenofovir or efavirenz (ESS30009 Study) [31] | 169 | 71.0 | 94.5 | 130 | HLA-B*5701 genotype test was not screening. The majority of subjects in the tenofovir arm switched regimens or withdrew before week 16 |
Multicenter, randomized, open-label study of abacavir/lamivudine or tenofovir/emtricitabine administered with efavirenz (ASSERT Study) [32] | 192 | 64.2 (61 of 95 patients with viral load <100.000 copies/mL) | N/D | 150 | HLA-B*5701 genotype negative. Viral load suppression as secondary efficacy endpoints |
Multicenter and randomized study of efavirenz with abacavir/lamivudine or lopinavir/r with abacavir/lamivudine (Lake Study) [33] | 63 | 56.7 | 87.0 | 193 | HLA-B*5701 genotype test was not screening. Results included patients with viral load <100.000 or > 100.000 copies/mL |
Multicenter retrospective study of tenofovir-emtricitabine or abacavir-lamivudine, administered with efavirenz for 260 weeks (TOKEN Study) [40] | 75 | N/D | 85 | 135 | HLA-B*5701 genotype negative. Estimated values at 48 week from Fig. 1a (viral load <40 copies/mL) and Fig. 1b (CD4 count) |