ODIN STUDY
- A randomized, open-label, 48-week, Phase 3, noninferiority clinical trial comparing darunavir 800 mg coadministered with ritonavir 100 mg once daily vs darunavir 600 mg coadministered with 100 mg ritonavir twice daily in treatment-experienced adult patients with viral load >1000 copies/mL and no darunavir resistance-associated mutations, or DRV RAMs (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, and L89V)
- Patients were stratified by screening HIV-1 RNA (<50,000 or >50,000 copies/mL) and then randomized (1:1) to receive Once-Daily DRV/r 800/100 mg (n=294) or twice-daily DRV/r 600/100 mg (n=296) plus an investigator-selected optimized background regimen (OBR) consisting of >2 NRTIs based on ARV history and resistance testing1
Primary objective1
- Demonstrate noninferiority of Once-Daily DRV/r 800/100 mg vs twice-daily DRV/r 600/100 mg in confirmed virologic response (HIV-1 RNA <50 copies/mL [ITT-TLOVR]) at Week 48 with a noninferiority margin (delta) of 12%
BASELINE PATIENT DEMOGRAPHICS
AND DISEASE CHARACTERISTICS1
|
Once-Daily DRV/r 800/100 mg + OBR (n=294) |
Twice-daily DRV/r 600/100 mg + OBR (n=296) |
|
|
Demographic & baseline disease characteristics |
||
|---|---|---|
| Median age (years) | 40 | 40 |
| Gender | ||
| Male | 61% | 67% |
| Female | 39% | 33% |
| Mean plasma viral load (log10 copies/mL) | 4.19 | 4.13 |
| Patients with viral load (copies/mL) | ||
| <100,000 | 87% | 89% |
| =100,000 | 13% | 11% |
| Median CD4+ cell count (cell/mm3) | 219 | 236 |
| Median DRV RAMs* (range) | 0 (0-2) | 0 (0-1) |
BASELINE ARV EXPERIENCE1,2
|
Once-Daily DRV/r 800/100 mg + OBR (n=294) |
Twice-daily DRV/r 600/100 mg + OBR (n=296) |
|
| Previously used ARVs | ||
|---|---|---|
| NNRTI (>1) | 88% | 87% |
| NRTI (>3) | 59% | 55% |
| PI (0) | 46% | 46% |
| PI (1) | 25% | 26% |
| PI (>2) | 29% | 28% |
| Fusion inhibitor (1) | 0.3% | 0% |
| Integrase inhibitor (1) | 0.3% | 0% |
| Primary PI mutations | ||
| 0 | 84% | 85% |
| >1 | 16% | 16% |
| PI RAMs | ||
| 0-2 | 34% | 29% |
| 3-4 | 39% | 41% |
| >5 | 27% | 31% |
*40% of subjects used boosted PIs and 14% of subjects used unboosted PIs. The most common previously used PIs were LPV/r (26%) and indinavir (21%).1
ARV=antiretroviral; DRV/r=darunavir coadministered with ritonavir; ITT-TLOVR=intent-to-treat, time-to-loss of virologic response; LPV/r=lopinavir/ritonavir; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; OBR=optimized background regimen; PI=protease inhibitor; RAMs=resistance-associated mutations.
References: 1. Data on file. Janssen Therapeutics, Division of Janssen Products, LP. 2. Cahn P, Fourie J, Grinsztejn B, et al. Week 48 analysis of once-daily vs. twice-daily darunavir/ritonavir in treatment-experienced HIV-1-infected patients. AIDS. 2011;25:929-939.