Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)

Giambenedetto, Simona Di; Fabbiani, Massimiliano; Quiros-Roldan, Eugenia; Latini, Alessandra; d’Ettorre, Gabriella; Antinori, Andrea; Castagna, Antonella; Orofino, Giancarlo; Francisci, Daniela; Chinello, Pierangelo; Madeddu, Giordano; Grima, Pierfrancesco; Rusconi, Stefano; Pietro, Massimo Di; Mondi, Annalisa; Ciccarelli, Nicoletta; Borghetti, Alberto; Focà, Emanuele; Colafigli, Manuela; Luca, Andrea De; Cauda, Roberto

doi:10.1093/jac/dkw557

Cited by 44 publications

(58 citation statements)

References 23 publications

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“…3TC [27,28]. While safety outcomes from the studies were consistent with previous findings, studies including ATV produced more cases of hyperbilirubinemia, scleral icterus, and elevations in liver function tests (LFTs) and bilirubin [29,31,32], while the study including LPV/r experienced more frequent GI upset [31].…”

Section: Nrti Inclusivesupporting

confidence: 84%

“…ATV/ r ? 3TC regimens have consistently met noninferiority, evidenced in both simplification from a previous ATV/r-based regimen and switching from a variety of PI and NNRTI-based 3DRs (ATLAS-M, SALT) [29,32,33]. There is limited evidence studying DRV in this population, although results from the DUAL-GESIDA study are promising [30].…”

Section: Discussionmentioning

confidence: 99%

“…Seven non-inferiority studies of NRTI-inclusive 2DRs in treatment-experienced populations were identified ( Table 2) [27][28][29][30][31][32][33][34]. The COOL study evaluating EFV ?…”

Section: Nrti Inclusivementioning

confidence: 99%

“…Four of the studies included a boosted PI ? 3TC (two studied ATV/r, one LPV/r, and one DRV/r) [29][30][31][32][33], while two studies included DTG ? 3TC [27,28].…”

Section: Nrti Inclusivementioning

confidence: 99%

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Two’s a Company, Three’s a Crowd: A Review of Initiating or Switching to a Two-Drug Antiretroviral Regimen in Treatment-Naïve and Treatment-Experienced Patients Living with HIV-1

Badowski¹,

Pérez²,

Schwartz³

et al. 2020

Infect Dis Ther

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Introduction: As HIV has become a manageable chronic condition, a renewed and increased interest in challenging traditional three-drug HIV therapies and moving toward two-drug regimens (2DR) for initial or maintenance treatment in people living with HIV (PLWH) has developed. As PLWH are living longer, continual advancements in antiretroviral regimens have been a focus to provide optimal lifelong therapy options. Although early studies may have shown poor outcomes in virologic suppression with 2DR, newer studies and treatment options have emerged to show promise in the management of HIV. The purpose of this review is to evaluate current literature and assess the efficacy of two-drug (2DR) antiretroviral therapy in treatment-naïve and -experienced people living with HIV.

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Section: Nrti Inclusivesupporting

confidence: 84%

Section: Discussionmentioning

confidence: 99%

“…Seven non-inferiority studies of NRTI-inclusive 2DRs in treatment-experienced populations were identified ( Table 2) [27][28][29][30][31][32][33][34]. The COOL study evaluating EFV ?…”

Section: Nrti Inclusivementioning

confidence: 99%

“…Four of the studies included a boosted PI ? 3TC (two studied ATV/r, one LPV/r, and one DRV/r) [29][30][31][32][33], while two studies included DTG ? 3TC [27,28].…”

Section: Nrti Inclusivementioning

confidence: 99%

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Two’s a Company, Three’s a Crowd: A Review of Initiating or Switching to a Two-Drug Antiretroviral Regimen in Treatment-Naïve and Treatment-Experienced Patients Living with HIV-1

Badowski¹,

Pérez²,

Schwartz³

et al. 2020

Infect Dis Ther

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“… Notes: ^NRTI costs consider a weighted mean of the cost of the backbones used within the Atlas-M trial,20 that is, TDF/FTC; TDF+3TC; ABC+3TC; AZT+3TC; ddl+3TC; TDF+ABC.*Because of lack of data, the same cost of ATV+r+2 NRTI was considered. Abbreviations: ART, antiretroviral treatment; ATV, atazanavir; NRTI, nucleoside reverse transcriptase inhibitor; r, ritonavir; EVG, elvitegravir; c, cobicistat; TDF, tenofovir; FTC, emtricitabine; 3TC, lamivudine; ABC, abacavir; ddl, didanosine; AZT, zidovudine.…”

Section: Figurementioning

confidence: 99%

Budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial

Restelli¹,

Fabbiani

Giambenedetto

et al. 2017

CEOR

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BackgroundThis analysis aimed at evaluating the impact of a therapeutic strategy of treatment simplification of atazanavir (ATV)+ ritonavir (r) + lamivudine (3TC) in virologically suppressed patients receiving ATV+r+2 nucleoside reverse transcriptase inhibitors (NRTIs) on the budget of the Italian National Health Service (NHS).MethodsA budget impact model with a 5-year time horizon was developed based on the clinical data of Atlas-M trial at 48 weeks (in terms of percentage of patients experiencing virologic failure and adverse events), from the Italian NHS perspective. A scenario in which the simplification strategy was not considered was compared with three scenarios in which, among a target population of 1,892 patients, different simplification strategies were taken into consideration in terms of percentage of patients simplified on a yearly basis among those eligible for simplification. The costs considered were direct medical costs related to antiretroviral drugs, adverse events management, and monitoring activities.ResultsThe percentage of patients of the target population receiving ATV+r+3TC varies among the scenarios and is between 18.7% and 46.9% in year 1, increasing up to 56.3% and 84.4% in year 5. The antiretroviral treatment simplification strategy considered would lead to lower costs for the Italian NHS in a 5-year time horizon between −28.7 million € and −16.0 million €, with a reduction of costs between −22.1% (−3.6 million €) and −8.8% (−1.4 million €) in year 1 and up to −39.9% (−6.9 million €) and −26.6% (−4.6 million €) in year 5.ConclusionThe therapy simplification for patients receiving ATV+r+2 NRTIs to ATV+r+3TC at a national level would lead to a reduction of direct medical costs over a 5-year period for the Italian NHS.

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Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

Saag

Benson

Gandhi

et al. 2018

JAMA

518

287

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IMPORTANCE Antiretroviral therapy (ART) is the cornerstone of prevention and management of HIV infection. OBJECTIVE To evaluate new data and treatments and incorporate this information into updated recommendations for initiating therapy, monitoring individuals starting therapy, changing regimens, and preventing HIV infection for individuals at risk. EVIDENCE REVIEW New evidence collected since the International Antiviral Society–USA 2016 recommendations via monthly PubMed and EMBASE literature searches up to April 2018; data presented at peer-reviewed scientific conferences. A volunteer panel of experts in HIV research and patient care considered these data and updated previous recommendations. FINDINGS ART is recommended for virtually all HIV-infected individuals, as soon as possible after HIV diagnosis. Immediate initiation (eg, rapid start), if clinically appropriate, requires adequate staffing, specialized services, and careful selection of medical therapy. An integrase strand transfer inhibitor (InSTI) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) is generally recommended for initial therapy, with unique patient circumstances (eg, concomitant diseases and conditions, potential for pregnancy, cost) guiding the treatment choice. CD4 cell count, HIV RNA level, genotype, and other laboratory tests for general health and co-infections are recommended at specified points before and during ART. If a regimen switch is indicated, treatment history, tolerability, adherence, and drug resistance history should first be assessed; 2 or 3 active drugs are recommended for a new regimen. HIV testing is recommended at least once for anyone who has ever been sexually active and more often for individuals at ongoing risk for infection. Preexposure prophylaxis with tenofovir disoproxil fumarate/emtricitabine and appropriate monitoring is recommended for individuals at risk for HIV. CONCLUSIONS AND RELEVANCE Advances in HIV prevention and treatment with antiretroviral drugs continue to improve clinical management and outcomes for individuals at risk for and living with HIV.

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Treatment simplification to atazanavir/ritonavir + lamivudine versus maintenance of atazanavir/ritonavir + two NRTIs in virologically suppressed HIV-1-infected patients: 48 week results from a randomized trial (ATLAS-M)

Abstract: Treatment simplification to atazanavir/ritonavir + lamivudine showed non-inferior efficacy (superiority on post-hoc analysis) and a comparable safety profile over continuing atazanavir/ritonavir + two NRTIs in virologically suppressed patients.

Cited by 44 publications

References 23 publications

Two’s a Company, Three’s a Crowd: A Review of Initiating or Switching to a Two-Drug Antiretroviral Regimen in Treatment-Naïve and Treatment-Experienced Patients Living with HIV-1

Two’s a Company, Three’s a Crowd: A Review of Initiating or Switching to a Two-Drug Antiretroviral Regimen in Treatment-Naïve and Treatment-Experienced Patients Living with HIV-1

Budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

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