Table 3.
Summary of raltegravir switch studies
| Study | Design | Eligibility | Treatment | Efficacy results |
|---|---|---|---|---|
| SWITCHMRK 1 and 247 | Phase III R, DB, AC, MC 1:1 allocation ratio |
Age ≥18 years HIV-1 RNA <50 c/mL for ≥3 months on LPV/r regimen |
LPV/r 400/100 mg BID + BBR RAL 400 mg BID + BBR |
<50 c/mL at week 24 (non-completion = failure) RAL: 84.4% (293/347) LPV/r: 90.6% (319/352) Did not establish noninferiority of RAL to LPV/r, leading to early termination |
| EASIER ARNS 13845,48 | R, OL, MC 1:1 allocation ratio |
Age ≥18 years ART-experienced INSTI-naïve HIV-1 RNA <400 c/mL for >3 months on ENF regimen |
ENF 90 mg SQ BID + BBR RAL 400 mg BID + BBR At week 24, ENF arm was offered to switch to RAL; all of them switched |
<50 c/mL at week 24 (ITT) RAL: 88% ENF: 89% <50 c/mL at week 48 RAL: 90% |
| SPIRAL46 | R, OL, MC 1:1 allocation ratio |
Age ≥18 years PI-based ART HIV-1 RNA <50 c/mL for 6 months INSTI-naïve |
RTV-boosted PI + BBR RAL 400 mg BID + BBR |
% free of treatment failure at week 48 (non-completion = failure) RAL: 89.2% RTV-boosted PI: 86.6% |
| CHEER49 | OL, MC, HC | Age ≥18 years ENF-based ART HIV-1 RNA <50 c/mL for 6 months INSTI-naïve |
ENF 90 mg SQ BID + BBR RAL 400 mg BID + BBR |
<50 c/mL at week 24 (ITT) RAL: 94.2% (one virologic failure prior to week 24) |
| SWITCH-ER44 | R, DB, CO | Age ≥18 years EFV-based ART HIV-1 RNA <50 c/mL for 3 months |
Week 1 and 2 Group 1 RAL 400 mg BID + EFV placebo + BBR Group 2 EFV 600 mg Qday + RAL placebo + BBR Week 3 and 4 Group 1 EFV 600 mg Qday + RAL placebo + BBR Group 2 RAL 400 mg BID + EFV placebo + BBR |
Patient preference at week 4 64% expressed a preference: 35% favored EFV, 65% favored RAL 36% reported two treatments as equal |
Abbreviations: AC, active controlled; ART, antiretroviral therapy; BBR, baseline background regimen; BID, twice daily; c/mL, copies/milliliter; CO, cross-over; DB, double blind; EFV, efavirenz; ENF, enfuvirtide; HC, historic control; INSTI, integrase strand-transfer inhibitor; ITT, intention-to-treat analysis; LPV/r, lopinavir/ritonavir; MC, multicenter; OL, open label; PI, protease inhibitor; Qday, daily; R, randomized; RAL, raltegravir; RNA, ribonucleic acid; RTV, ritonavir; SQ, subcutaneous.