Table 2 Key recent studies of switch to NRTI-sparing regimens in virologically suppressed patients on standard ART

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 + 2^nd 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