Dual Therapy With Darunavir and Ritonavir Plus Lamivudine vs Triple Therapy With Darunavir and Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine or Abacavir and Lamivudine for Maintenance of Human Immunodeficiency Virus Type 1 Viral Suppression: Randomized, Open-Label, Noninferiority DUAL-GESIDA 8014-RIS-EST45 Trial

Pulido, Federico; Iribarren, José Antonio; Ryan, Pablo; Knobel, Hernando; Arribas, José Ramón; Arribas, JR; Montejano, Rocío; González‐García, Juan; Montes, María Luisa; Bernardino, José I; Pérez‐Valero, Ignacio; Castro, Juan M.; Mayoral, Mario; Pulido, Federico; Lagarde, María; Bisbal, Otilia; Matarranz, Mariano; Hernando, Asunción; Domínguez-Domínguez, Lourdes; Rubio, Rafael; Ribera, Esteban; Curran, Adrían; Navarro, J. F.; Burgos, Joaquín; Ocaña, I; Falcó, Vicenç; Santos, Jesús; Palacios, Rosario; Pérez, Ignacio Plaza; González-Domenech, Carmen M.; Ibarguren, Maialen; Goenaga, Miguel Ángel; Rodríguez-Arrondo, Francisco; Wichmann, Miguel Ángel von; Kortajarena, Xabier; Carmona, MP; Llatzer, H Son; Payeras, Antoni; Rayá, Mercedes; Salom, A; Domingo, Peré; Gutiérrez, Mar; Mateo, María; Sambeat, María A.; Sanz, José; Miguel, J. De; Casas, E; Arranz, Alberto; Cervero, Miguel; Torres, Rafael; Elena, H Infanta; Rodríguez-Gómez, Francisco Javier; Fajardó, J M; Martínez‐Marcos, Francisco Javier; Merino, María de la Paz Valverde; Raffo, Miguel; Suárez-Lozano, Ignacio; Clínico, H.; Téllez, María J.; Vergas, Jorge; Estrada, Vicente; Leonor, H Infanta; Ryan, Pablo; Troya, Jesús; Cuevas, Guillermo; Diez-Viñas, V; Talaván, Tamar; Solis, F; Mataró, H de; Barrufet, Pilar; Force, Lluís; Mar, Hanna; Knobel, Hernando; González, Alicia; Lerma, Edgar V.; Villar, J. Pablo Sáez; Sofía, H Reina; Rivero, Antonio; Camacho, Ángela; Machuca, Isabel; Brieva, Teresa; Rivero‐Juárez, Antonio; Gatell, JM; Rojas, Jhon; Podzamczer, Daniel; Eynde, Eva Van den; Acerete, Laura; Navarro, Andrés; DiYacovo, María Silvana; Nieves, H Virgen de las; Pasquau, Juan; García, Coral; Losa, JE; Henriquez, Cecilia; Portilla, J.; Giner, Livia; Portilla, Irene; Pampliega, M; Boix, Vicente; Merino, Esperanza; Reus, Sergio; Torrús, Diego; Clotet, Bonaventura; Negredo, Eugènia; Chamarro, A; Corbasi, P; Gil-Pérez, Desiré; Arazo, Piedad; Parras, FranciscoJosé; Ramírez, Margarita; Gutiérrez-Cuéllar, I; Espases, H Son; Riera, Melchor; Gil-Alonso, L; Vilchez, Helem H; Yllescas, María; Alejos, Belén; Aznar, E. Ubiña; Esteban, Herminia; González, Pablo Rivas; Gonzalez, Socorro; Miguel, Marta de

doi:10.1093/cid/cix734

Cited by 98 publications

(63 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Some low/middle-income countries have used generic ART formulations to address the cost challenge [10,11]. Others have explored whether monotherapy or dual therapy can be used safely to reduce costs [12][13][14][15]. Strategic use of newly available generic antiretroviral (ARV) drugs has now entered the cost discussion in high-income countries, with modelling studies projecting significant savings from any increased use of generic ART [16][17][18][19][20][21].…”

Section: Introductionmentioning

confidence: 99%

De‐simplifying single‐tablet antiretroviral treatments: uptake, risks and cost savings

et al. 2019

View full text Add to dashboard Cite

Objectives As more HIV‐positive individuals receive antiretroviral therapy (ART), payers are seeking options for covering these increased and sustained drug costs. Strategic use of available generic antiretroviral (ARV) formulations may be feasible. De‐simplifying a single‐tablet co‐formulation (STF) into two or more tablets using both brand and generic drugs has been proposed. We determine if voluntary de‐simplification of one STF could be utilized as a cost‐saving strategy. We report on the challenges, uptake, outcomes and cost savings of this initiative. Methods Patients stable on the most commonly used STF (Triumeq®) were offered the option of remaining on Triumeq® or switching to generic abacavir/lamivudine and Tivicay® between 1 January 2015 and 1 January 2018; those starting ART consisting of abacavir/lamivudine/doulutegravir in the same period were offered the option of starting Triumeq® or generic abacavir/laminvudine and Tivicay®. No incentives were provided. We examined the acceptance/decline rates, patient satisfaction, health care outcomes and annual cost savings. Results Of 626 patients receiving Triumeq®, 321 were approached; 177 (55.1%) agreed to de‐simplify. Of patients initiating ART, 62.7% chose the generic co‐formulation. Patients switching to or starting on the generic co‐formulation were more likely to be male, > 45 years old, Caucasian, men who have sex with men (MSM) and more HIV‐experienced, and to have more comorbidities (all P < 0.05). Preference for STF was cited for declining de‐simplification. No concern about generic ARVs was expressed. The rate of viral load > 500 HIV‐1 RNA copies/mL after baseline was 2.7% in switched patients compared with 7.0% in those declining to switch. No de novo resistance occurred. A saving of Cdn$1 319 686 was achieved in the first year. Conclusions Reliance on altruism, while respecting patient autonomy, achieved de‐simplification in > 50% of patients approached, and generated immediate cost savings with no increased risk of adverse events, viral breakthrough or resistance.

show abstract

Section: Introductionmentioning

confidence: 99%

De‐simplifying single‐tablet antiretroviral treatments: uptake, risks and cost savings

et al. 2019

View full text Add to dashboard Cite

show abstract

“…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]. These studies have not been associated with treatment-emergent resistance and have similar rates of viral suppression to comparator 3DRs.…”

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%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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.

show abstract

“…This finding was not observed in a randomized study comparing the same dual regimen vs . standard triple therapy , because randomized studies were performed in selected patients, without prior toxicity and with a short duration of previous therapy, and are therefore not representative of this indication in real‐life settings. With this limitation, the findings suggest that dual therapies are promising strategies, and our data confirm that they could help to reduce renal toxicity, to a similar or greater extent compared with switching from TDF to abacavir, because these patients had worse baseline characteristics, a longer duration of HIV infection and TDF use, and more previous lines of cART.…”

Section: Discussionmentioning

confidence: 99%

Switching to abacavir versus use of a nucleoside‐sparing dual regimen for HIV‐infected patients with tenofovir‐associated renal toxicity

et al. 2018

View full text Add to dashboard Cite

Tenofovir disoproxil fumarate discontinuation was associated with a rapid and significant improvement in eGFR and tubular abnormalities, regardless of whether abacavir or dual therapy was chosen. Switching to a regimen that included dolutegravir and/or rilpivirine was associated with a eGFR decrease without differences in the rate of tubular dysfunction improvement in comparison with the rest of patients who discontinued tenofovir.

show abstract

Abstract: NCT02159599.

Cited by 98 publications

References 14 publications

De‐simplifying single‐tablet antiretroviral treatments: uptake, risks and cost savings

De‐simplifying single‐tablet antiretroviral treatments: uptake, risks and cost savings

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

Switching to abacavir versus use of a nucleoside‐sparing dual regimen for HIV‐infected patients with tenofovir‐associated renal toxicity

Contact Info

Product

Resources

About