Durability of Lopinavir/Ritonavir Monotherapy in Individuals with Viral Load ≦50 Copies/Ml in an Observational Setting

Monforte, Antonella d’Arminio; Gianotti, Nicola; Cozzi‐Lepri, Alessandro; Pinnetti, Carmela; Andreoni, Massimo; Perri, Giovanni Di; Galli, Massimo; Poli, Andrea; Costantini, Andrea; Orofino, Giancarlo; Maggiolo, Franco; Mazzarello, Giovanni; Celesia, Benedetto Maurizio; Luciani, Filippo; Lazzarin, Adriano; Sighinolfi, Laura; Rizzardini, Giuliano; Bonfanti, Paolo; Perno, Carlo Federico; Antinori, Andrea

doi:10.3851/imp2687

Cited by 5 publications

(7 citation statements)

References 9 publications

(16 reference statements)

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“…We found an increasing risk of virological failure with shorter duration of VL suppression prior to switch to monotherapy, as has been found in other studies [6][7][8]. A related measure, shorter time of prior ART exposure, was found to be a risk factor in the MONOI trial on darunavir monotherapy [9].…”

Section: Discussionsupporting

confidence: 68%

“…Lower nadir CD4 counts [3][4][5][6], a shorter duration of VL suppression [6][7][8] or treatment prior to monotherapy [9], detectable baseline HIV-VL [9,10], hepatitis C virus (HCV) coinfection [10,11] and non-adherence to treatment [4,9] have all been identified as predictors, although not consistently. The impact of the type of VL assay does not appear to have been explored.…”

Section: Introductionmentioning

confidence: 99%

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Factors associated with virological rebound in HIV-infected patients receiving protease inhibitor monotherapy

Stöhr

Dunn

Arenas‐Pinto

et al. 2016

Aids

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Objective: The PIVOT trial found that protease inhibitor (PI) monotherapy as a simplification strategy is safe in terms of drug resistance but less effective than combination therapy in suppressing HIV viral load (VL). We sought to identify factors associated with the risk of VL rebound in this trial.Methods: PIVOT was a randomized controlled trial in HIV-positive adults with suppressed VL for ≥24 weeks on combination therapy comparing a strategy of physician-selected ritonavir-boosted PI monotherapy versus ongoing triple therapy. In participants receiving monotherapy, we analysed time to confirmed VL rebound and its predictors using flexible parametric survival models.Results: Of 290 participants initiating PI monotherapy (80% darunavir, 14% lopinavir, 6% other), 93 developed VL rebound on monotherapy. The risk of VL rebound peaked at 9 months after starting monotherapy, and then declined to approximately 5 per 100 personyears from 18 months onwards. Independent predictors of VL rebound were duration of VL suppression prior to starting monotherapy (hazard ratio [HR] 0.81 per additional year <50 copies/mL; p<0.001), CD4 cell count (HR 0.73 per additional 100 cells/mm 3 for CD4 nadir; p=0.008); ethnicity (HR 1.87 for non-white versus white, p=0.025) but not the PI agent used (p=0.27). Patients whose VL was analysed with the Roche Taqman-2 assay had a 1.87-fold risk for VL rebound compared with Abbott RealTime assay (p=0.012). Conclusions:A number of factors can identify patients at low risk of rebound with PI monotherapy and this may help to better target those who may benefit from this management strategy.

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Section: Discussionsupporting

confidence: 68%

Section: Introductionmentioning

confidence: 99%

Factors associated with virological rebound in HIV-infected patients receiving protease inhibitor monotherapy

Stöhr

Dunn

Arenas‐Pinto

et al. 2016

Aids

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“…A recent study published by d’Arminio Monforte et al 10 confirmed in daily practice the efficacy and durability of LPV/r monotherapy in 228 patients with at least two consecutive HIV RNA ≤50 copies/mL in regimens including three or more drugs.…”

Section: Introductionmentioning

confidence: 85%

“…Several studies have investigated the clinical efficacy of protease inhibitor (PI)-based monotherapies. 6 – 10 …”

Section: Introductionmentioning

confidence: 99%

Budget impact analysis of antiretroviral less drug regimen simplification in HIV-positive patients on the Italian National Health Service

Restelli¹,

Andreoni²,

Antinori³

et al. 2014

CEOR

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BackgroundDeintensification and less drug regimen (LDR) antiretroviral therapy (ART) strategies have proved to be effective in terms of maintaining viral suppression in human immunodeficiency virus (HIV)-positive patients, increasing tolerability, and reducing toxicity of antiretroviral drugs administered to patients. However, the economic impact of these strategies have not been widely investigated. The aim of the study is to evaluate the economic impact that ART LDR could have on the Italian National Health Service (INHS) budget.MethodsA budget impact model was structured to assess the potential savings for the INHS by the use of ART LDR for HIV-positive patients with a 3 year perspective. Data concerning ART cost, patient distribution within different ARTs, and probabilities for patients to change ART on a yearly basis were collected within four Italian infectious diseases departments, providing ART to 13.7% of the total number of patients receiving ART in Italy.ResultsThe LDR investigated (protease inhibitor-based dual and monotherapies) led to savings for the hospitals involved when compared to the “do nothing” scenario on a 3 year basis, between 6.7% (23.11 million €) and 12.8% (44.32 million €) of the total ART expenditures. The mean yearly cost per patient is reduced from 9,875 € in the do nothing scenario to a range between 9,218 € and 8,615 €. The use of these strategies within the four departments involved would have led to a reduction of ART expenditures for the INHS of between 1.1% and 2.1% in 3 years.ConclusionART LDR simplification would have a significant impact in the reduction of ART-related costs within the hospitals involved in the study. These strategies could therefore be addressed as a sustainable answer to the public financing reduction observed within the INHS in the last year, allowing therapies to be dispensed without affecting the quality of the services provided.

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“…Different studies were able to identify a number of factors associated with failure to PI/r-MT, including nadir and baseline CD4+ count, duration of viral suppression, previous failure to ART, HCV co-infection, PI in the baseline cART, residual viremia levels at time of switch, hemoglobin levels, age, VL at cART initiation, gender, mode of HIV transmission [ 26 – 37 ]. In a previous study, we investigated factors associated to failure of LPV/r-MT and we found that factors associated with a lower risk of treatment failure (TF) were the duration of viral suppression <50 copies/mL prior to baseline and having LPV/r as part of last cART [ 38 ]. However, in that study the possible role of residual viremia in predicting failure of MT had not been investigated.…”

Section: Introductionmentioning

confidence: 99%

Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients

Gianotti¹,

Cozzi‐Lepri

Antinori

et al. 2017

PLoS ONE

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ObjectiveThe primary objective of this study was to estimate the incidence of treatment failure (TF) to protease inhibitor monotherapies (PI/r-MT) with lopinavir/ritonavir (LPV/r) or darunavir/ritonavir (DRV/r).DesignA multicenter cohort of HIV-infected patients with viral load (VL) ≤50 copies/mL, who underwent a switch from any triple combination therapy to PI/r-MT with either LPV/r or DRV/r.MethodsVL was assessed in each center according to local procedures. Residual viremia was defined by any HIV-RNA value detectable below 50 copies/mL by a Real-Time PCR method. Standard survival analysis was used to estimate the rate of TF (defined by virological failure or interruption of monotherapy or reintroduction of combination therapy). A multivariable Cox regression analysis with automatic stepwise procedures was used to identify factors independently associated with TF among nadir and baseline CD4+ counts, residual viremia, time spent with <50 HIV-RNA copies/mL before switch, history of virological failure, HCV co-infection, being on a PI/r and hemoglobin concentrations at baseline.ResultsSix hundred ninety patients fulfilled the inclusion criteria and were included in this analysis. Their median follow-up was 20 (10–37) months. By month 36, TF occurred in 176 (30.2%; 95% CI:25.9–34.5) patients. Only CD4+ nadir counts (adjusted hazard ratio [aHR] = 2.03 [95% CI: 1.35, 3.07] for counts ≤100 vs. >100 cells/μL) and residual viremia (aHR = 1.48 [95% CI: 1.01–2.17] vs. undetectable VL) were independently associated to TF.ConclusionsResidual viremia and nadir CD4+ counts <100 cells/μL should be regarded as the main factors to be taken into account before considering switching to a PI/r-MT.

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Durability of Lopinavir/Ritonavir Monotherapy in Individuals with Viral Load ≦50 Copies/Ml in an Observational Setting

Cited by 5 publications

References 9 publications

Factors associated with virological rebound in HIV-infected patients receiving protease inhibitor monotherapy

Factors associated with virological rebound in HIV-infected patients receiving protease inhibitor monotherapy

Budget impact analysis of antiretroviral less drug regimen simplification in HIV-positive patients on the Italian National Health Service

Refining criteria for selecting candidates for a safe lopinavir/ritonavir or darunavir/ritonavir monotherapy in HIV-infected virologically suppressed patients

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