3.02
 2.16, 4.20
 <.0001
 
HIV RNA <400 copies/ml**
 201 (30.4%)
 40 (12.0%)
 Odds Ratio 3.45
 2.36, 5.06
 <.0001
 
HIV RNA <50 copies/ml**
 121 (18.3%)
 26 (7.8%)
 Odds Ratio 2.77
 1.76, 4.37
 <.0001
 
Discontinued due to adverse reactions/intercurrent illness/labs†
 9%
 11%
      
Discontinued due to injection site reactions†
 4%
 N/A
      
Discontinued due to other reasons†φ§
 13%
 25%
      

* Based on results from pooled data of TORO 1 and TORO 2 on ITT population, week 48 viral load for subjects who were lost to follow-up, discontinued therapy, or had virological failure replaced by their last observation (LOCF).

# Last value carried forward.

** M-H test: Discontinuations or virological failure considered as failures.

† Percentages based on safety population Fuzeon+background (N=663) and background (N=334). Denominator for non-switch patients: N=112.

φ As per the judgment of the investigator.

§ Includes discontinuations from loss to follow-up, treatment refusal, and other reasons.

Fuzeon + OB therapy was associated with a higher proportion of patients reaching <400 copies/ml (or <50 copies/ml) across all subgroups based on baseline CD4, baseline HIV-1 RNA, number of prior antiretrovirals (ARVs) or number of active ARVs in the OB regimen. However, subjects with baseline CD4 >100 cells/mm3, baseline HIV-1 RNA <5.0 log10 copies/ml, ≤ 10 prior ARVs, and/or other active ARVs in their OB regimen were more likely to achieve a HIV-1 RNA of <400 copies/ml (or <50 copies/ml) on either treatment (see Table 6).

Table 6 Proportion of Patients achieving <400 copies/ml and <50 copies/ml at Week 48 by subgroup (pooled TORO 1 and TORO 2, ITT)

Subgroups
 HIV-1 RNA < 400 copies/ml
 HIV-1 RNA < 50 copies/ml
 
Fuzeon + OB

90 mg bid

(N=661)
 OB

(N=334)
 Fuzeon + OB

90 mg bid

(N=661)
 OB

(N=334)
 
BL HIV-1 RNA < 5.0 log101 copies/ml
 118/269

(43.9%)
 26/144

(18.1%)
 77/269

(28.6%)
 18/144

(12.5%)
 
BL HIV-1 RNA ≥ 5.0 log101 copies/ml
 83/392

(21.2%)
 14/190

(7.4%)
 44/392

(11.2%)
 8/190

(4.2%)
 
Total prior ARVs ≤ 101
 100/215

(46.5%)
 29/120

(24.2%)
 64/215

(29.8%)
 19/120

(15.8%)
 
Total prior ARVs > 101
 101/446

(22.6%)
 11/214

(5.1%)
 57/446

(12.8%)
 7/214

(3.3%)
 
0 Active ARVs in background1,2
 9/112

(8.0%)
 0/53

(0%)
 4/112

(3.5%)
 0/53

(0%)
 
1 Active ARV in background1,2
 56/194

(28.9%)
 7/95

(7.4%)
 34/194

(17.5%)
 3/95

(3.2%)
 
≥ 2 Active ARVs in background1,2
 130/344

(37.8%)