Patient-Reported Outcomes in ATLAS and FLAIR Participants on Long-Acting Regimens of Cabotegravir and Rilpivirine Over 48 Weeks

Overview

Journal AIDS Behav

Specialty Infectious Diseases

Date 2020 May 25

PMID 32447500

Citations 24

Authors

Miranda Murray

Antonio Antela

Anthony Mills

Jenny Huang

Hans Jager

Enrique Bernal

Johan Lombaard

Harold Katner

Sharon Walmsley

Marie-Aude Khuong-Josses

Krischan Hudson

David Dorey

Sandy Griffith

William Spreen

Simon Vanveggel

Mark Shaefer

David Margolis

Vasiliki Chounta

Affiliations

Soon will be listed here.

Abstract

The phase 3 ATLAS and FLAIR studies demonstrated that maintenance with Long-Acting (LA) intramuscular cabotegravir and rilpivirine is non-inferior in efficacy to current antiretroviral (CAR) oral therapy. Both studies utilized Patient-Reported Outcome instruments to measure treatment satisfaction (HIVTSQ) and acceptance (ACCEPT general domain), health status (SF-12), injection tolerability/acceptance (PIN), and treatment preference. In pooled analyses, LA-treated patients (n = 591) demonstrated greater mean improvements from baseline than the CAR group (n = 591) in treatment satisfaction (Week 44, + 3.9 vs. +0.5 HIVTSQs-points; p < 0.001) and acceptance (Week 48, +8.8 vs. +2.0 ACCEPT-points; p < 0.001). The acceptability of injection site reactions (PIN) significantly improved from week 5 (2.10 points) to week 48 (1.62 points; p < 0.001). In both studies, ≥ 97% of LA group participants with recorded data preferred LA treatment compared with prior oral therapy. These results further support the potential of a monthly injectable option for people living with HIV seeking an alternative to daily oral treatment.

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References

Iacob S, Iacob D, Jugulete G . Improving the Adherence to Antiretroviral Therapy, a Difficult but Essential Task for a Successful HIV Treatment-Clinical Points of View and Practical Considerations. Front Pharmacol. 2017; 8:831. PMC: 5703840. DOI: 10.3389/fphar.2017.00831. View

Orkin C, Arasteh K, Gorgolas Hernandez-Mora M, Pokrovsky V, Overton E, Girard P . Long-Acting Cabotegravir and Rilpivirine after Oral Induction for HIV-1 Infection. N Engl J Med. 2020; 382(12):1124-1135. DOI: 10.1056/NEJMoa1909512. View

Swindells S, Andrade-Villanueva J, Richmond G, Rizzardini G, Baumgarten A, Masia M . Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020; 382(12):1112-1123. DOI: 10.1056/NEJMoa1904398. View

Woodcock A, Bradley C . Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006; 9(5):320-33. DOI: 10.1111/j.1524-4733.2006.00121.x. View

Marant C, Longin J, Gauchoux R, Arnould B, Spizak C, Marrel A . Long-term treatment acceptance: what is it, and how can it be assessed?. Patient. 2012; 5(4):239-49. DOI: 10.2165/11631340-000000000-00000. View

Ousmen A, Touraine C, Deliu N, Cottone F, Bonnetain F, Efficace F . Distribution- and anchor-based methods to determine the minimally important difference on patient-reported outcome questionnaires in oncology: a structured review. Health Qual Life Outcomes. 2018; 16(1):228. PMC: 6288886. DOI: 10.1186/s12955-018-1055-z. View

Wukich D, Sambenedetto T, Mota N, Suder N, Rosario B . Correlation of SF-36 and SF-12 Component Scores in Patients With Diabetic Foot Disease. J Foot Ankle Surg. 2016; 55(4):693-6. PMC: 5664160. DOI: 10.1053/j.jfas.2015.12.009. View

Jordan J, Cahn P, Goebel F, Matheron S, Bradley C, Woodcock A . Abacavir compared to protease inhibitors as part of HAART regimens for treatment of HIV infection: patient satisfaction and implications for adherence. AIDS Patient Care STDS. 2005; 19(1):9-18. DOI: 10.1089/apc.2005.19.9. View

Lambert J, Chekroun M, Gilet H, Acquadro C, Arnould B . Assessing patients' acceptance of their medication to reveal unmet needs: results from a large multi-diseases study using a patient online community. Health Qual Life Outcomes. 2018; 16(1):134. PMC: 6034222. DOI: 10.1186/s12955-018-0962-3. View

10.

Mayer L, Kappos L, Racke M, Rammohan K, Traboulsee A, Hauser S . Ocrelizumab infusion experience in patients with relapsing and primary progressive multiple sclerosis: Results from the phase 3 randomized OPERA I, OPERA II, and ORATORIO studies. Mult Scler Relat Disord. 2019; 30:236-243. DOI: 10.1016/j.msard.2019.01.044. View

11.

Weld E, Rana M, Dallas R, Camacho-Gonzalez A, Ryscavage P, Gaur A . Interest of Youth Living With HIV in Long-Acting Antiretrovirals. J Acquir Immune Defic Syndr. 2018; 80(2):190-197. PMC: 6331217. DOI: 10.1097/QAI.0000000000001896. View

12.

Savitz A, Xu H, Gopal S, Nuamah I, Ravenstijn P, Janik A . Efficacy and Safety of Paliperidone Palmitate 3-Month Formulation for Patients with Schizophrenia: A Randomized, Multicenter, Double-Blind, Noninferiority Study. Int J Neuropsychopharmacol. 2016; 19(7). PMC: 4966278. DOI: 10.1093/ijnp/pyw018. View

13.

Gardner E, Sharma S, Peng G, Hullsiek K, Burman W, MacArthur R . Differential adherence to combination antiretroviral therapy is associated with virological failure with resistance. AIDS. 2007; 22(1):75-82. PMC: 2405889. DOI: 10.1097/QAD.0b013e3282f366ff. View

14.

Williams J, Sayles H, Meza J, Sayre P, Sandkovsky U, Gendelman H . Long-acting parenteral nanoformulated antiretroviral therapy: interest and attitudes of HIV-infected patients. Nanomedicine (Lond). 2013; 8(11):1807-13. PMC: 3987826. DOI: 10.2217/nnm.12.214. View

15.

Trezza C, Ford S, Spreen W, Pan R, Piscitelli S . Formulation and pharmacology of long-acting cabotegravir. Curr Opin HIV AIDS. 2015; 10(4):239-45. PMC: 5638427. DOI: 10.1097/COH.0000000000000168. View

16.

Kerrigan D, Mantsios A, Gorgolas M, Montes M, Pulido F, Brinson C . Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a Phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018; 13(1):e0190487. PMC: 5755771. DOI: 10.1371/journal.pone.0190487. View

17.

Boretzki J, Wolf E, Wiese C, Noe S, Balogh A, Meurer A . Highly specific reasons for nonadherence to antiretroviral therapy: results from the German adherence study. Patient Prefer Adherence. 2017; 11:1897-1906. PMC: 5687417. DOI: 10.2147/PPA.S141762. View

18.

Been S, Schade A, Bassant N, Kastelijns M, Pogany K, Verbon A . Anxiety, depression and treatment adherence among HIV-infected migrants. AIDS Care. 2019; 31(8):979-987. DOI: 10.1080/09540121.2019.1601676. View

19.

Ware Jr J, Kosinski M, Keller S . A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996; 34(3):220-33. DOI: 10.1097/00005650-199603000-00003. View

20.

Ortego C, Huedo-Medina T, Llorca J, Sevilla L, Santos P, Rodriguez E . Adherence to highly active antiretroviral therapy (HAART): a meta-analysis. AIDS Behav. 2011; 15(7):1381-96. DOI: 10.1007/s10461-011-9942-x. View