Table 2.
Key recent studies of switch to NRTI-sparing regimens in virologically suppressed patients on standard ART
| Author, name of the trial, if any/year/published? | Design | Comparison | N | Follow-up (weeks) | Results |
|---|---|---|---|---|---|
| Monteiro et al. [36]/2013/Yes |
Observational |
RAL + ETV |
25 |
48 |
-91% virologically suppressed in per-protocol analysis |
| |
|
|
|
|
-Lipids improved |
| Ward et al. [26]/2013/No |
Observational |
Switching for toxicity concerns to a RAL + 1 or 2 agents, most commonly on RAL + ATV/r with or without ETV or MVC |
62 |
168 |
-92% virologically suppressed; |
| |
|
-3 of 15 on dual therapy had to add third agent for low-level viremia |
|||
| Calin et al. [27]/2013/No |
Observational |
Switching to RAL + ETV regimen |
91 |
48 |
-93% had viral load <50 copies/mL |
| |
|
|
|
|
-4/5 with virological failures had past NNRTI mutations |
| |
|
|
|
|
-3 patients had RAL mutations |
| Katlama et al. [28], ROCnRAL/2013/No |
Single-arm exploratory trial |
R5-trophic suppressed patients switched to MVC + RAL |
41 |
48 |
-Failure in 11.4% |
| |
|
-RAL mutations in 3/5 patients who failed |
|||
| |
|
|
-1/5 had R5 to ×4 virus switch |
||
| Cotte et al. [29], No Nuc No Boost/2013/No |
Single-arm exploratory trial |
MVC + RAL |
10 |
48 |
-No virological failures (>50 copies/mL) |
| |
|
|
-No serious adverse event |
||
| Burgos et al. [30]/2012/No |
Observational |
Switching for toxicity concerns to a PI/r + 2nd agent, many with no NRTI |
131 |
56 |
- > 90% virologically suppressed. |
| Ofotokun et al. [31], KITE/2012/No |
Exploratory pilot trial |
(i) LPV/r + RAL; (ii) standard ART |
60 |
48 |
-92% in arm (i) and 88% in arm (ii) with viral load <50 copies/mL; |
| |
|
|
|
|
-Higher triglycerides in arm (i) |
| |
|
|
|
|
-No difference in BMD or body composition. |
| Carey et al. [32], SPARTA/2012/Yes |
Pilot cross-over RCT |
Patients receiving ATV/r randomized to: (i) ATV/r (300/100 mg respectively once daily) + RAL (800 mg once daily) |
25 |
76% in follow-up for 48 weeks |
-Both agents pharmacologically compatible. |
| (ii) ATV (300 mg twice daily) + RAL (400 mg twice daily) |
-All patients remained virologically suppressed |
||||
| Cordery et al. [35]/2010/Yes |
Observational |
RAL + ATV (unboosted) |
20 |
72 |
-Only 1 (5%) failure |
| Allavena et al. [33]/2009/Yes |
Observational |
Switching for toxicity concerns to a PI/r + RAL. |
29 |
48 |
-100% virologically suppressed |
| Fischl et al. [34]/2007/Yes |
RCT, not fully powered |
(i) LPV/r + EFV; |
236 |
96 |
-Arm (i): shorter time to failure or discontinuation; |
| (ii) EFV + NRTIs | |||||
| -Arm (i): greater increase in triglycerides |