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