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Current HIV Research

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ISSN (Print): 1570-162X
ISSN (Online): 1873-4251

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Research Article

Real World Patient-reported Outcomes in HIV-infected Adults Switching to EVIPLERA®, Because of a Previous Intolerance to cART. PRO-STR Study

Author(s): D. Podzamczer*, N. Rozas, P. Domingo, C. Miralles, E. Van den Eynde, A. Romero, E. Deig, H. Knobel, J. Pasquau, A. Antela, B. Clotet, P. Geijo, E. Rodríguez de Castro, M.A. Casado, A. Muñoz, A. Casado and for the PRO-STR STUDY GROUP

Volume 16, Issue 6, 2018

Page: [425 - 435] Pages: 11

DOI: 10.2174/1570162X17666190212163518

Abstract

Background: To investigate the impact of switching from stable Combined Antiretroviral Therapy (cART) to single-tablet regimen (RPV/FTC/TDF=EVIPLERA® /COMPLERA®) on patient- reported outcomes in HIV-infected adults who cannot tolerate previous cART, in a real-world setting.

Methods: PRO-STR is a 48-week observational, prospective, multicenter study. Presence and magnitude of symptoms (main endpoint), health-related quality-of-life (HRQoL), adherence, satisfaction with treatment and patient preferences were assessed.

Results: Three hundred patients with 48-week follow-up, who switched to EVIPLERA® (mean age: 46.6 years; male: 74.0%; 74.7% switched from a non-nucleoside reverse-transcriptase-inhibitor, 25.3% from a protease inhibitor + ritonavir) were included. There was no statistical difference in median CD4+ cell count (baseline: 678.5 cells/mm3; 48-week: 683.0 cells/mm3) neither in virological suppression (≤50 copies/mL) (baseline: 98.3%; 48-week: 95.3%). The most frequent reasons for switching were neuropsychiatric (62.3%), gastrointestinal (19.3%) and biochemical/metabolic (19.3%) events. Only 7.7% of patients permanently discontinued therapy. At 48-week, all outcomes showed an improvement compared to baseline. Overall, there was a significant decrease (pvalue≤ 0.05) in number and magnitude of symptoms, while HRQoL, satisfaction and adherence improved significantly. Most patients prefered EVIPLERA® than previous cART. According to the type of intolerance, HRQoL was improved, but only significantly in patients with neuropsychiatric and gastrointestinal symptoms. Adherence improved significantly in patients with metabolic disturbances and satisfaction with EVIPLERA® was higher in the three groups.

Conclusion: Switching to EVIPLERA® from non-nucleoside reverse-transcriptase-inhibitor or protease inhibitor-based regimens due to toxicity, improved the presence/magnitude of symptoms, HRQoL, and preference with treatment. EVIPLERA® maintained a virological response, CD4+ cell count and maintained or improved adherence.

Keywords: HIV, patient-reported outcomes, single treatment regimen, real-world evidence, health-related quality-of-life, Eviplera®.

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[1]
Johnson LF, Mossong J, Dorrington RE, et al. International Epidemiologic Databases to Evaluate AIDS Southern Africa Collaboration Life expectancies of South African adults starting antiretroviral treatment: collaborative analysis of cohort studies. PLoS Med 2013; 10: e1001418.
[2]
Nakagawa F, May M, Phillips A. Life expectancy living with HIV: recent estimates and future implications. Curr Opin Infect Dis 2013; 26: 17-25.
[3]
Clay PG, Nag S, Graham CM, et al. Meta-Analysis of Studies Comparing Single and Multi-Tablet Fixed Dose Combination HIV Treatment Regimens. Medicine 2015; 94: e1677.
[4]
Blanco JL, Montaner JS, Marconi VC, et al. Lower prevalence of drug resistance mutations at first-line virological failure to first-line therapy with atripla vs. tenofovir + emtricitabine/lamivudine + efavirenz administered on a multiple tablet therapy. AIDS 2014; 28: 2531-9.
[5]
Cohen CJ, Meyers JL, Davis KL. Association between daily antiretroviral pill burden and treatment adherence, hospitalisation risk, and other healthcare utilisation and costs in a US medic aid population with HIV. BMJ Open 2013; 3: e003028.
[6]
Lin MK, Wu AW, Revicki DA. Incorporating quality of life measures in HIV clinical trials. HIV Clin Trials 2002; 3: 202-18.
[7]
Clayson DJ, Wild DJ, Quarterman P, et al. A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials. Pharmacoeconomics 2006; 24: 751-65.
[8]
Mafirakureva N, Dzingirai B, Postma MJ, van Hulst M, Khoza S. Health-related quality of life in HIV/AIDS patients on antiretroviral therapy at a tertiary care facility in Zimbabwe. AIDS Care 2016; 21: 1-9.
[9]
Simpson KN, Hanson KA, Harding G, et al. Patient reported outcome instruments used in clinical trials of HIV-infected adults on NNRTI-based therapy: a 10-year review. Health Qual Life Outcomes 2013; 11: 164.
[10]
Cunningham SD, Card JJ. Realities of replication: implementation of evidence-based interventions for HIV prevention in real-world settings. Implement Sci 2014; 9: 5.
[11]
National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Rockville: National Cancer Institute; 2010. Available in:. http://evs.nci.nih.gov/ftp1/CTCAE/ CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf [Accessed on May 27, 2016]
[12]
Regnault A, Marfatia S, Louie M, et al. Satisfactory cross-cultural validity of the ACTG symptom distress module in HIV-1-infected antiretroviral-naive patients. Clin Trials 2009; 6: 574-84.
[13]
EuroQol Group. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990; 16: 199-208.
[14]
Badia X, Roset M, Monserrat S, et al. La versión española del EuroQol: descripción y aplicaciones. Med Clin (Barc) 1999; 112: 79-85.
[15]
Herdman M, Badia X, El Berra S. EuroQol-5D: una alternativa sencilla para la medición de la calidad de vida relacionada con la salud en atención primaria. Aten Primaria 2001; 6: 425-30.
[16]
Badía X, Podzamczer D, López-Lavid C, et al. Evidence-based medicine and the validation of quality-of-life questionnaires: the Spanish version of the MOS-HIV questionnaire for the evaluation of the quality of life in patients infected by HIV. Enferm Infecc Microbiol Clin 1999; 17: 103-13.
[17]
Badía X, Podzamczer D, Casado A, et al. Evaluating changes in health status in HIV-infected patients: Medical Outcomes Study-HIV and Multidimensional Quality of Life-HIV quality of life questionnaires. Spanish MOS-HIV and MQOL-HIV Validation Group. AIDS 2000; 14: 1439-47.
[18]
Knobel H, Alonso J, Casado JL, et al. GEEMA Study Group Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study. AIDS 2002; 16: 605-13.
[19]
Ventura JM, Casado MA, Morales JM, et al. Características psicométricas de la escala de satisfacción con el tratamiento antirretroviral (ESTAR): Estudio ARPAS (I). Farm Hosp 2007; 31: 331-9.
[20]
Ventura JM, Casado MA, Escobar I, et al. Preferencias, satisfacción y adherencia con el tratamiento antirretroviral. Estudio ARPAS (II). Farm Hosp 2007; 31: 340-52.
[21]
Wilkins EL, Cohen CJ, Trottier B, et al. Patient-reported outcomes in the single-tablet regimen (STaR) trial of rilpivirine/ emtricitabine/tenofovirdisoproxil fumarate versus efavirenz/ emtricitabine/ tenofovirdisoproxil fumarate in antiretroviral treatment-naive adults infected with HIV-1 through 48 weeks of treatment. AIDS Care 2016; 28: 401-8.
[22]
Hodder SL, Mounzer K, Dejesus E, et al. AI266073 Study Group. Patient-reported outcomes invirologically suppressed, HIV-1-Infected subjects after switching to a simplified, single-tablet regimen of efavirenz, emtricitabine, and tenofovir DF. AIDS Patient Care STDS 2010; 24: 87-96.
[23]
Highleyman L. Switching from Atripla to Eviplera reduces central nervous system side-effects.Poster presented at 53rdInterscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). 23 September 2013.
[24]
Di Matteo S, Bruno GM, Astuti N, et al. Switching from an EFV-Based STR to an RPV-Based STR is Effective, Safe and Improves HIV Patients Health Status. Value Health 2014; 17: A677-8.
[25]
Ventura Cerdá JM, Martín Conde MT, Morillo Verdugo R, et al. Adherence, satisfaction and health-related quality of life in HIV-infected patients with antiretroviral therapy in Spain. The ARPAS study. Farm Hosp 2014; 38: 291-9.
[26]
Brunetta J, Moreno Guillén S, Antinori A, et al. Patient-reported outcomes after a switch to a single-tablet regimen of rilpivirine, emtricitabine, and tenofovir DF in HIV-1-positive, virologically suppressed individuals: Additional findings from a randomized, open-label, 48-week trial. Patient 2015; 8: 257-67.
[27]
Cazanave C, Reigadas S, Mazubert C, et al. Switch to Rilpivirine/ Emtricitabine /Tenofovir Single-Tablet Regimen of Human Immunodeficiency Virus-1 RNA-Suppressed Patients, Agence Nationale de Recherches sur le SIDA et les Hépatites Virales CO3 Aquitaine Cohort, 2012-2014. Open Forum Infect Dis 2015; 12; 2(1): ofv018
[28]
Cohen CJ, Andrade-Villanueva J, Clotet B, et al. THRIVE study group Rilpivirine versus efavirenz with two background nucleoside or nucleotide reverse transcriptase inhibitors in treatment-naive adults infected with HIV-1 (THRIVE): a phase 3, randomised, non-inferiority trial. Lancet 2011; 378: 229-37.
[29]
Van Lunzen J, Antinori A, Cohen CJ, et al. Rilpivirine vs. efavirenz-based single-tablet regimens In treatment-naive adults: week 96 efficacy and safety from a randomized phase 3bstudy. AIDS 2016; 30: 251-9.
[30]
Gathe J, Arribas JR, Van Lunzen J, et al. Patient-reported symptoms over 48 weeks in a randomized, open-label,phase 3b non-inferiority trial of adults with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir DF versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir DF. Patient 2015; 8: 445-54.
[31]
Prinapori R, Di Biagio A. Efficacy, safety, and patient acceptability of elvitegravir/cobicistat/emtricitabine/tenofovir in the treatment of HIV/AIDS. Patient Prefer Adherence 2015; 9: 1213-8.

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