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Table 3 Key recent studies of switch to NRTI-sparing first-line ART regimens in ART naïve patients

From: Antiretroviral regimens sparing agents from the nucleoside(tide) reverse transcriptase inhibitor class: a review of the recent literature

Author, name of the trial, if any/year/published?

Design

Comparison

N

Follow-up (weeks)

Results

Mills et al. [41], A4001078/2013/Yes

RCT, phase-2b pilot

(i) MVC + ATV/r

121

48

-75% in arm (i) and 84% in arm (ii) had viral load <50 copies/mL.

(ii) TDF + FTC + ATV/r

     

-More hyperbilirubenmia in arm (i)

     

-Nine in arm (i) and 3 in arm (ii) had low-level viremia after virological suppression

Reynes et al. [42], PROGRESS/2013/Yes

RCT pilot study

(i) LPV/r + RAL

(i) 101; (ii) 105

96

-66.3% in arm (i) and 68.6% in arm (ii) responded by FDA-TLOVR

(ii) LPV/r + TDF + FTC

     

-Better body comp in arm (i)

     

-Greater decline in eGFR in arm (ii)

Kozal et al. [47], SPARTAN/2012/Yes

RCT pilot study

(i) ATV + RAL

(i) 63; (ii) 31

24

-74.6% in arm (i) and 63.3% in arm (ii) had viral load <50 copies/mL

(ii) ATV/r + TDF + FTC

     

-4/6 failures in arm (i) had RAL mutations.

     

-20% incidence of grade-4 hyperbilirubenimia in arm (i).

Taiwo et al. [43, 48], MIDAS/2013/Yes

Single-arm pilot

MVC + DRV/r

25

96

-Viral load < 50 copies/mL: 8.3% and 10% at week 48 and 96, respectively.

     

-Virological failures mainly explained be high baseline viral load >100000 copies/mL

Bedimo R et al. [44], RADAR/2011/No

RCT pilot

(i) RAL + DRV/r

80

24

-86% in arm (i) and 87% in arm (ii) had viral load <50 copies/mL

(ii) DRV/r + TDF + FTC

Taiwo et al. [45], ACTG5262/2011/Yes

Single-arm pilot

DRV/r + RAL

112

48

-26% with viral load > 50 copies/mL, majority with low-level viremia (<200 copies/mL)

     

-Baseline viral load >100000 copies/mL strongly associated with failure

Riddler et al. [46], ACTG5142/2008/Yes

RCT

(i) EFV + NRTIs

(i) 250

96

-89%, 77% and 83% had viral load <50 copies/mL in arms (i), (ii) and (iii) respectively

(ii) LPV/r + NRTIs

(ii) 253

(iii) LPV/r + EFV

(iii) 250

     

-No difference in time to toxic effects

     

-At failure, resistance mutations more common in arm (iii)

  1. NOTE for Tables 1, 2, 3: ATV/r = ritonavir boosted atazanavir, DRV/r = ritonavir boosted darunavir, LPV/r = ritonavir boosted lopinavir, RAL = raltegravir, ETV = etravirine, MVC = maraviroc, EFV = efavirenz, TDF = tenofovir, FTC = emtricitabine, NRTI = Nucleoside(tide) reverse transcriptase inhibitors, PI = protease inhibitors.