Table 1 Comparison of SECOND-LINE and EARNEST studies
From: Superiority and non-inferiority: two sides of the same coin?
Study | SECOND-LINE [9] | EARNEST [10] |
|---|---|---|
Design | Non-inferiority | Superioritya |
Investigators’ rationale | Raltegravir less toxic than nucleoside reverse transcriptase inhibitors (NRTIs), aim to show similar efficacy | Raltegravir more expensive, aim to show better efficacy than NRTIs |
Setting | 37 sites in 15 countries in 5 continents | 14 sites in 5 sub-Saharan African countries |
Number of subjects | 588 | 859 |
Delta/non-inferiority margin | 12% | 10% |
Primary endpoint | Viral load < 200 copies/mL at 48 weeks | Composite endpoint (good HIV disease control) at 96 weeks |
Frequency of primary endpoint | 81% NRTI 83% raltegravir Difference = 1.8% (95% CI –4.7 to 8.3) | 60% NRTI 64% raltegravir Difference = 4.2% (95% CI –2.4 to 10.7) |
Conclusion | Criterion for non-inferiority fulfilled | Superiority of raltegravir not shown |
Interpretation (précised from paper Abstract) | The raltegravir regimen was easy to administer, effective, safe and tolerable … This simple NRTI-free treatment strategy might extend the successful public health approach to management of HIV | NRTIs retained substantial virologic activity without evidence of increased toxicity, and there was no advantage to replacing them with raltegravir |