Table 1 Key recent studies of NRTI-sparing regimens in treatment experienced patients
Author, name of the trial, if any/year/published? | Design | Comparison | N | Follow-up (weeks) | Results |
|---|---|---|---|---|---|
Boyd et al. [18], SECOND-LINE/2013/Yes | Phase-3/4 RCT, non-inferiority | (i) LPV/r + RAL vs. (ii) LPV/r + recycled NRTIs in those failing 1st line NNRTI-based ART | 541 (271 vs. 270) | 48 | -Arm (i) non-inferior to arm (ii) for virological outcome |
| Â | Â | Â | Â | Â | -No major differences in serious adverse events |
-Greater decline in BMD in arm (ii) [25] | |||||
Paton et al. [19], EARNEST/2013/No | Phase-3/4 RCT, non-inferiority | (i) LPV/r + RAL | (i) 433; (ii) 418; (iii) 426 | 96 | -Arm (i) non-inferior to arm (iii) for a composite of virological and clinical endpoint |
(ii) LPV/r monotherapy after induction with LPV/r + RAL | |||||
|  |  | (iii) LPV/r + recycled NRTIs (control) in those failing 1st line NNRTI-based ART |  |  | -Arm (ii) inferior to other arms for virological outcome and higher LPV/r resistance |
| Â | Â | Â | Â | Â | -No differences in grade 3/4 events |
Tashima et al. [20], OPTIONS/2013/No | Phase-3/4 RCT, non-inferiority | (i) NRTI-omitting optimised regimen | (i) 179; (ii) 181 | 48 | -Similar virlogical outcomes in both arms |
(ii) NRTI-including optimised regimen in triple-class experienced failing patients | Â | Â | -No differences in grade 3/4 events | ||
-Higher mortality in arm (ii). | |||||
Ruane et al. [24], INROADS/2013/No | Single-arm exploratory phase-2b trial | DRV/r + ETV in failing patients (78%) or ART naïve patients with transmitted resistance (22%) | 54 (75% completed the study) | 48 | -100% of ART naïve and 87% of failing patients achieved virological success. |
-2 patients developed ETV mutations and none had DRV mutations. | |||||
Imaz et al. [21]/2011/Yes | Observational | Salvage regimen of at least three active agents from DRV, ETV, RAL and MVC, with or without NRTIs | 122 | 48 | -78% virologically suppressed (equal in both arms) |
-Higher baseline viral load associated with worse outcomes. | |||||
Nozza et al. [22]/2011/Yes | Observational | Salvage regimen of RAL + MVC + ETV | 28 | 96 | -96% virologically suppressed (<50 copies/ml) |
Florence et al. [23]/2010/Yes | Observational | Salvage regimen of ETV + optimised regimen, 40% without NRTIs | 941 | 24 | -70% and 90% had viral load <50 and 400 copies/mL respectively. |