SPIRIT study: switching to emtricitabine/rilpivirine/tenofovir df (FTC/RPV/TDF) single-tablet regimen (STR) from a ritonavir-boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIS) maintains HIV suppression and improves seru
Background: Antiretroviral regimen simplification improves both quality of life, and long-term medication adherence while reducing the risk of HIV virologic failure (VF) and long-term drug-related toxicities. FTC/RPV/TDF is a well-tolerated, once daily STR treatment option. This is the first study to evaluate the efficacy and safety of switching from boosted Protease Inhibitor (PI) based HAART to a simplified regimen of FTC/RPV/TDF STR.
Methods: A randomized, open-label, multi-center, international, 48 week study to evaluate the safety and efficacy of switching from ritonavir-boosted PI regimens to FTC/RPV/TDF in virologically-suppressed (HIV RNA< 50 copies/mL), HIV-1 infected subjects. Participants were randomized 2:1 to switch to FTC/RPV/TDF or maintain their current PI-based regimen. The primary endpoint was non-inferiority (12% margin) of FTC/RPV/TDF relative to PI-based regimens in maintaining plasma HIV-1 RNA< 50 copies/mL at Week 24 by Snapshot analysis. Changes in serum lipids from baseline were evaluated.
Results: A total of 476 subjects were randomized and received at least 1 dose of study drug (317 FTC/RPV/TDF; 159 PI). Baseline characteristics were similar (table 1). Switching to FTC/RPV/TDF was non-inferior to maintaining a ritonavir-boosted PI regimen (93.4% versus 89.9%) at Week 24 for HIV RNA< 50 copies/mL (95% CI [-2.0%, 8.9%]). Fewer subjects in the FTC/RPV/TDF arm than the PI arm had virologic failure by Snapshot, defined as HIV RNA≥50 copies/mL at Week 24 or discontinuations of study drug with HIV RNA≥50 copies/mL (1.3% vs 5.0%). Two subjects in the FTC/RPV/TDF arm had emergent resistance and one in the PI arm. Overall total cholesterol, LDL, and triglycerides decreased to a greater extent among FTC/RPV/TDF than PI recipients (table 2).
|Black or African Heritage (%)||19.2||13.8|
|Age (mean, years)||41||43|
|CD4 (mean, cells/mm3)||576||600|
[Fasted Serum Lipids and Change from Baseline at We]
| ||Baseline||Mean Change at |
| ||FTC/RPV/TDF||PI||FTC/RPV/TDF||PI||p value|
|Total Cholesterol (mg/dL)||192||194||-25||-1||<0.001|
Conclusions: Switching to the FTC/RPV/TDF STR from a ritonavir-boosted PI regimen in virologically-suppressed, HIV-1-infected participants maintains virologic suppression with low risk of virologic failure while improving total cholesterol, LDL, and triglycerides.
19th International AIDS Conference
"F.Palella, et al.
SPIRIT study: switching to emtricitabine/rilpivirine/tenofovir df (FTC/RPV/TDF) single-tablet regimen (STR) from a ritonavir-boosted protease inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIS) maintains HIV suppression and improves seru.
19th International AIDS Conference: