Please use this identifier to cite or link to this item:
http://ir.mu.ac.ke:8080/jspui/handle/123456789/3394
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | MunderiI, Paula | - |
dc.contributor.author | WereII, Edwin | - |
dc.contributor.author | Avihingsanon, Anchalee | - |
dc.date.accessioned | 2020-08-06T09:53:37Z | - |
dc.date.available | 2020-08-06T09:53:37Z | - |
dc.date.issued | 2019 | - |
dc.identifier.uri | http://dx.doi.org/10.4102/sajhivmed.v20i1.949 | - |
dc.identifier.uri | http://ir.mu.ac.ke:8080/jspui/handle/123456789/3394 | - |
dc.description.abstract | BACKGROUND: In low- and middle-income countries (LMICs), a substantial unmet need for affordable single-tablet regimen (STR) options remains. Rilpivirine (RPV, TMC278) is formulated in a low-cost STR with tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC OBJECTIVES: Switching at Low HIV-1 RNA into Fixed Dose Combinations (SALIF) compared RPV with efavirenz (EFV), both as STRs with TDF and FTC, in maintaining virologic suppression METHODS: SALIF was a phase 3b, randomised, open-label, non-inferiority study in virologically suppressed adults (HIV-1 RNA < 50 copies/mL) on non-nucleoside reverse transcriptase inhibitor (NNRTI)-based first-line antiretroviral therapy (ART) in Cameroon, Kenya, Senegal, South Africa, Uganda and Thailand. Patients (N = 426), stratified by NNRTI use, were randomised 1:1 to receive TDF/FTC/RPV (300/200/25 mg qd) or TDF/FTC/EFV (300/200/600 mg qd). Primary endpoint was proportion of patients with virologic suppression (HIV-1 RNA < 400 copies/mL) at week 48 (intent-to-treat, modified Food and Drug Administration Snapshot, 10% non-inferiority margin RESULTS: Patients received TDF/FTC/RPV (n = 213) or TDF/FTC/EFV (n = 211). At week 48, virologic suppression was maintained in 200/213 (93.9%) patients in the RPV arm and 203/211 (96.2%) in the EFV arm (difference -2.3%; 95% confidence interval: −6.4, +1.8), demonstrating non-inferiority of TDF/FTC/RPV. One patient in each arm experienced virologic failure without treatment-emergent resistance. Twenty-seven patients discontinued prematurely (8.0% RPV vs. 4.7% EFV), the most frequent reasons being adverse events (3.3% vs. 0.5%, respectively), site closure (1.9% vs. 0.5%), loss to follow-up (0.9% vs. 1.4%) and consent withdrawal (0.9% vs. 1.4% CONCLUSION: In adults with suppressed viral load on first-line NNRTI-based ART in LMICs, switching to an STR of TDF/FTC/RPV was non-inferior to TDF/FTC/EFV in maintaining high rates of viral suppression with a comparable tolerability profile | en_US |
dc.language.iso | en | en_US |
dc.publisher | Southern African Journal of HIV Medicine | en_US |
dc.subject | Single-tablet-regimen | en_US |
dc.subject | Virologically suppressed adults | en_US |
dc.title | Switching at Low HIV-1 RNA into Fixed Dose Combinations: TDF/FTC/RPV is non-inferior to TDF/FTC/EFV in first-line suppressed patients living with HIV | en_US |
dc.type | Article | en_US |
Appears in Collections: | School of Medicine |
Files in This Item:
There are no files associated with this item.
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.