Table 1.
Summary of Trials Comparing Tenofovir Formulations in ART-Experienced PLWH with Baseline HIV-RNA <50 copies/mL.
| Study Agents | Study Design and Patient Population | Virologic Suppression 48 weeks | CrCl (mL/min)a | Bone Density (%)a | Lipids (TC:HDL ratio)a | Treatment-Emergent RAMs | |
|---|---|---|---|---|---|---|---|
| Hip | Lumbar Spine | ||||||
| EVG/c/FTC/TAF versus ATV + RTV + FTC/TDF10 | Open label, switch, women, noninferiority | EVG/c/FTC/TAF: 94% (150/159) | 4.2 | 2.1 | 2.8 | 0.1 | None |
| ATV + RTV + FTC/TDF: 87% (46/53) | −1.8; P = .06b | 1.3; P = .29b | 0; P < .001b | 0.0; P = .075b | None | ||
| GS-US-366-1160; RPV/FTC/TAF versus EFV/FTC/TDF11 | Multicenter, randomized double blind, placebo controlled, noninferiority | RPV/FTC/TAF: 90% (394/438) | −4.1 (95% CI: −12.7 to 4.6) | 1.28 | 1.65 | 0.1 | None |
| EFV/FTC/TDF: 92% (402/437) | −0.6 (95% CI: −7.8 to 6.7); P < .0001b | −0.13; P < .0001b | −0.05; P < .0001b | 0; P = .20b | M184V, V106I/L (n = 1) | ||
| GS-US-311-1089 (subgroup analysis); boosted PIc + FTC/TAF or FTC/TDF versus unboosted-third agentd + FTC/TAF or FTC/TDFa,6 | Multicenter, controlled, double blind, switch | Boosted PIc + FTC/TAF: 92% | 7.7 (95% CI: 0.1 to 15.1) | 1.233 | 1.544 | 0.1 (95% CI: −0.2 to 0.7) | M184V (n = 1) |
| Boosted PIc + FTC/TDF: 93% | 3.3 (95% CI: −6.0 to 12.3); P < .05b | −0.089; P < .001b | −0.354; P < .001b | 0.1 (95% CI: -0.3 to 0.4) | None | ||
| Unboosted third agentd + FTC/TAF: 97% | 9.3 (95% CI 0.6-15.8) | 1.051 | 1.511 | 0.1 (95% CI: −0.3 to 0.5) | None | ||
| Unboosted third agentd + FTC/TDF: 93% | 2.8 (95% CI 3.7 to 10.1); P < .05b | −0.205; P < .001b | −0.081; P < .001b | 0.0 (95% CI: −0.4 to=0.4) | None | ||
| GS-US-366-1216; RPV/FTC/TAF versus RPV/FTC/TDF7 | Multicenter, randomized double blind, switch, noninferiority | RPV/FTC/TAF: 94% (296/316) | 4.5 (95% CI: −4.1 to 12.3) | 1.04 | 1.61 | 0.1 | None |
| RPV/FTC/TDF: 94% (294/313) | 0.7 (95% CI: −6.6 to 8.1); P = .0024b | −0.25; P < .0001b | 0.08; P < .0001b | 0.1; P = .18b | None | ||
| GS-US-311-1089; TAF versus TDF8 | Multicenter, controlled, double blind, switch | TAF: 94% (314/333) | 8.4 (95% CI 0.2 to 15.6) | 1.135 | 1.527 | 0.1 | M184V (n = 1) |
| TDF: 93% (307/330) | 2.8 (95% CI: −5.1 to 10.9); P < .0001b | −0.152; P < .001b | −0.206; P < .001b | 0; P = .073b | None | ||
| GS-US-292-0109; EVG/c/FTC/TAF versus TDF-based therapy9 | Open label, switch | EVG/c/FTC/TAF: 97% (932/959) | 1.2 (95% CI: −6.6 to 9.1) | 1.47 | 1.56 | NR | M184I/M (n = 1) |
| TDF-based therapy: 93% (444/477) | −3.7 (95% CI: −10.5 to 3.5); P < .0001b | −0.34; P < .0001b | −0.44; P < .0001b | None | |||
| EMERALD; Boosted PI + FTC/TDF versus DRV/c/FTC/TAF STR12 | Multicenter, randomized, open label, switch Primary boosted PIs at enrollment: DRV: 70% versus 70%; ATV: 22% versus 22%; LPV: 8% versus 8%; c: 17% versus 14% |
Boosted PIe + FTC/TDF: 94% (354/378) | −1.9; P = .0007 | −0.26; P = .78 | −0.63; P = .98 | 0.1 | None |
| DRV/c/FTC/TAF STR: 95% (724/764) | −0.4; P = .24 | 1.43; P < .001 | 1.49; P < .001 | 0.2 | None | ||
Abbreviations: ART, antiretroviral therapy; ATV, atazanavir; c, cobicistat; CI, confidence interval; CrCl, creatinine clearance; DRV, darunavir; EFV, efavirenz; EVG, elvitegravir; FTC, emtricitabine; HDL, high-density lipoprotein; LPV, lopinavir; NR, not reported; PI, protease inhibitor; PLWH, people living with HIV; RAM, resistance-associated mutation; RPV, rilpivirine; RTV, ritonavir; STR, single-tablet regimen; TAF, tenofovir alafenamide; TC, total cholesterol; TDF, tenofovir disoproxil fumarate.
a Change from baseline.
b P values for all between-group differences (FTC/TAF versus FTC/TDF).
c Boosted PI = ATV + RTV, DRV + RTV, or lopinavir/RTV (LPV/r).
d Unboosted third agent = unboosted third agents (EFV, RPV, nevirapine, raltegravir, dolutegravir, or maraviroc).
e Boosted PI = DRV/c, DRV/r, ATV/r, ATV/c, LPV/r.