Efficacy, safety and pharmacokinetics of atazanavir (200mg twice daily) plus raltegravir (400mg twice daily) dual regimen in the clinical setting

Marinaro, Letizia; Calcagno, Andrea; Ripamonti, Diego; Cenderello, Giovanni; Pirriatore, Veronica; Trentini, Laura; Salassa, B; Bramato, C; Orofino, Giancarlo; D’Avolio, Antonio; Rizzi, Marco; Perri, Giovanni Di; Rusconi, Stefano; Bonora, Stefano

doi:10.1016/j.jcv.2016.11.015

Cited by 6 publications

(2 citation statements)

References 35 publications

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“…The main study limitation includes the limited sample size, as this was designed as a pilot trial, the premature close of the study, and the lack of pharmacokinetic analysis. However, the randomized design of the pilot study, and contemporary published studies revealing similar trends (such as the reports published by Van Lunzen et al 13 and Marinaro et al 14 ), support the conclusions.…”

Section: (Which Was Not Certified By Peer Review)supporting

confidence: 77%

Dual therapy with Atazanavir/ritonavir plus Raltegravir versus triple therapy with Atazanavir/ritonavir plus Tenofovir-Emtricitabine after failure to an NNRTI regimen: 48-week results of the randomized pilot study ARTE trial

Figueroa

Sued

César

et al. 2022

Preprint

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Background: Dual therapy has emerged as a novel concept for HIV treatment. The ARTE study was aimed at comparing a nucleoside-sparing dual regimen consisting of ATV/r + RAL (DT) vs standard therapy of ATV/r + TDF/FTC (TT) among individuals failing first NNRTI-containing treatment. Methods: Randomized multicenter open-label pilot study. Primary outcome: proportion of subjects with plasma HIV-1 RNA below the limit of detection (<50 copies/mL) at 48 weeks (W48). Secondary outcomes: proportion of discontinuation due to adverse events (AEs), time until viral suppression, time until loss of virological response, development of integrase resistance mutations, and absolute change in CD4 counts. The primary outcome was analyzed using the FDA snapshot analysis. Results: Out of 57 participants screened, 34 were randomized to receive: DT (n: 18) or TT (n: 16). At W48, virological response was achieved in 67% (n: 12/18) of participants receiving DT and 88% (n: 14/16) receiving TT by FDA snapshot analysis (p = NS) and, 73% and 93% by per-protocol analysis (p = NS). CD4 cell count median change from baseline to W48 was +119 and + 52 cell/μL in DT and TT, respectively. Four participants receiving DT and one TT presented virological failure at W48, with low pVL. One participant developed an integrase resistance mutation (155H) and suppressed later on TT. Conclusion: ATV/r+RAL as second-line therapy showed a trend to more frequent virological failure, compared to TT, although the study was unpowered to prove this difference. No major differences were seen in tolerance or toxicity.

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Section: (Which Was Not Certified By Peer Review)supporting

confidence: 77%

Dual therapy with Atazanavir/ritonavir plus Raltegravir versus triple therapy with Atazanavir/ritonavir plus Tenofovir-Emtricitabine after failure to an NNRTI regimen: 48-week results of the randomized pilot study ARTE trial

Figueroa

Sued

César

et al. 2022

Preprint

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“…Another retrospective trial with unboosted ATV + RAL showed similarly concerning results (N=102, 18.6% failure at 123 weeks). 35 Both of these trials reported frequent selection for RAL resistance. HARNESS was a prospective trial comparing ATV/r + RAL vs ATV/r + two NRTIs for maintenance therapy in individuals who did not have a history of virologic failure or exposure to ATV or RAL.…”

Section: Maintenance Therapy In Virologically Suppressed Individualsmentioning

confidence: 99%

Two-drug regimens for treatment of naïve HIV-1 infection and as maintenance therapy

Corado

Caplan

Daar

2018

DDDT

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As people live longer with HIV infection, there has been a resurgence of interest in challenging the use of three-drug therapy, including two nucleoside reverse transcriptase inhibitors plus a third drug, as initial treatment of HIV infection or for maintenance therapy in virologically suppressed individuals. Although initial studies showed poor efficacy and/or substantial toxicity, more recent regimens have held greater promise. The SWORD-1 and -2 studies were pivotal trials of dolutegravir plus rilpivirine as maintenance therapy in virologically suppressed patients with no history of drug resistance, leading to the US Food and Drug Administration’s approval of the regimen as a small, single tablet. More recently, the GEMINI-1 and -2 studies demonstrated that dolutegravir plus lamivudine is as safe and effective as the same regimen when combined with tenofovir disoproxil fumarate in treatment-naïve individuals. Together, these and other studies of novel two-drug regimens offer the potential for improved tolerability and simplicity, as well as a reduction in cost. We will review historical and recent trials of two-drug therapy for the treatment of HIV-1 infection.

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Atazanavir/raltegravir

2017

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Efficacy, safety and pharmacokinetics of atazanavir (200mg twice daily) plus raltegravir (400mg twice daily) dual regimen in the clinical setting

Cited by 6 publications

References 35 publications

Dual therapy with Atazanavir/ritonavir plus Raltegravir versus triple therapy with Atazanavir/ritonavir plus Tenofovir-Emtricitabine after failure to an NNRTI regimen: 48-week results of the randomized pilot study ARTE trial

Dual therapy with Atazanavir/ritonavir plus Raltegravir versus triple therapy with Atazanavir/ritonavir plus Tenofovir-Emtricitabine after failure to an NNRTI regimen: 48-week results of the randomized pilot study ARTE trial

Two-drug regimens for treatment of naïve HIV-1 infection and as maintenance therapy

Atazanavir/raltegravir

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Efficacy, safety and pharmacokinetics of atazanavir (200mg twice daily) plus raltegravir (400mg twice daily) dual regimen in the clinical setting

Cited by 6 publications

References 35 publications

Dual therapy with Atazanavir/ritonavir plus Raltegravir versus triple therapy with Atazanavir/ritonavir plus Tenofovir-Emtricitabine after failure to an NNRTI regimen: 48-week results of the randomized pilot study ARTE trial

Dual therapy with Atazanavir/ritonavir plus Raltegravir versus triple therapy with Atazanavir/ritonavir plus Tenofovir-Emtricitabine after failure to an NNRTI regimen: 48-week results of the randomized pilot study ARTE trial

Two-drug regimens for treatment of na&iuml;ve HIV-1 infection and as maintenance therapy

Atazanavir/raltegravir

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Two-drug regimens for treatment of naïve HIV-1 infection and as maintenance therapy