Penta HIV Trials | PENTA 16 (BREATHER)

Economic evaluation of weekends-off antiretroviral therapy for young people in 11 countries

2018

Authors: Tierrablanca LE, Ochalek J, Ford D, et al; for BREATHER (PENTA 16) Trial Group

Published in: Medicine (Baltimore). 2018;97(5):e9698

Objectives To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs.

Weekends-off efavirenz -based antiretroviral therapy in HIV infected children, adolescents and young adults (BREATHER): extended follow-up results of a randomised, open-label, non-inferiority trial

2018

Authors: Turkova A, Moore CL, Butler K, et al. for BREATHER (PENTA 16) Trial Group.

Published in: PLos One. 2018;13(4):e0196239.

Background Weekends off antiretroviral therapy (ART) may help engage HIV-1-infected young people facing lifelong treatment. BREATHER showed short cycle therapy (SCT; 5 days on, 2 days off ART) was non-inferior to continuous therapy (CT) over 48 weeks.

Qualitative study of the BREATHER trial (Short Cycle antiretroviral therapy): is it acceptable to young people living with HIV?

2017

Authors: Bernays S, Paparini S, Seeley J, Namukwaya Kihika S, Gibb D, Rhodes T.

Published inBMJ Open. 2017;7(2):e012934

Objectives A qualitative study of the BREATHER (PENTA 16) randomised clinical trial, which compared virological control of Short Cycle Therapy (SCT) (5 days on: 2 days off) with continuous efavirenz (EFV)-based antiretroviral therapy (CT) in children and young people (aged 8–24) living with HIV with viral load <50 c/mL to examine adaptation,

“How Do We Start? And How Will They React?” Disclosing to Young People with Perinatally Acquired HIV in Uganda

2017

Authors: Namukwaya S, Paparini S, Seeley J, Bernays S.

Published in: Front Public Health. 2017;5:343.

Abstract: Despite great advances in pediatric HIV care, rates and the extent of full disclosure of HIV status to infected children remain low especially in resource-constrained setting. The World Health Organisation recommends that, by the age of 10-12 years old,

“Not Taking it Will Just be Like a Sin”: Young People Living with HIV and the Stigmatization of Less-Than-Perfect Adherence to Antiretroviral Therapy

2017

Authors: Bernays S, Paparini S, Seeley J, Rhodes T.

Published in: Med Anthropol. 2017;36(5):485-499.

Abstract: Global health priorities are being set to address questions on adherence to HIV antiretroviral therapy in adolescence. Few studies have explored young people’s perspectives on the complex host of social and relational challenges they face in dealing with their treatment in secret and their condition in silence.

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial

2016

Author: Butler K, Inshaw J, Ford D, et al.

Published in:  Health Technol Assess. 2016;20(49):1-108.

Background For human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings.

Objectives To determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy;

Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial

2016

Author: The BREATHER (PENTA 16) Trial Group

Published inLancet HIV. 2016;3(9):e421-430

Background For HIV-1-infected young people facing lifelong antiretroviral therapy (ART), short cycle therapy with long-acting drugs offers potential for drug-free weekends, less toxicity, and better quality-of-life. We aimed to compare short cycle therapy (5 days on, 2 days off ART) versus continuous therapy (continuous ART).

When information does not suffice: young people living with HIV and communication about ART adherence in the clinic

2016

Authors: S. Bernays, S. Paparini, D. Gibb & J. Seeley

Published in: Vulnerable Child Youth Stud. 2016;11(1):60-68

Abstract Despite mounting evidence recommending disclosure of human immunodeficiency virus (HIV) status to young people with perinatally acquired HIV as a central motivating factor for adherence to antiretroviral therapy, many young people continue to experience disclosure as a partial event,

I was like, oh my God, what happens if it doesn’t work’? Young people living with HIV, clinical trial participation and the truth economy

2015

Authors: Bernays S, Seeley J, Paparini S, Rhodes T

Published: BSA Medical Sociology Conference, York, 9-11 September 2015 (Paper ID No: W0012148)

I am scared of getting caught up in my lie’: challenges to self-reported adherence for young people living with HIV

2015

Authors:  Bernays S, Seeley J, Paparini S, Rhodes T and the ARROW and BREATHER trial teams.

Published in: accepted for presentation at AIDS Impact, Amsterdam 28-31 July, 2015 (abstract 3435)

Young people, clinical trials and ‘the HIV experience’: What can similarities across time and place tell us about growing up with HIV?

2015

Authors:  Paparini S on behalf of Bernays S, Seeley S,  Rhodes T,  Namukwaya Kihika S,Kawuma-Kigawa R, Nakyambadde H, Kabajaasi O and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

“But it’s my story”: exploring the experience and effect of telling children how they have acquired HIV

2015

Authors:  Seeley J on behalf of the Bernays S, Paparini S, Namukwaya Kihika S,  Rhodes T and the BREATHER Trial Team.

Published in: 3rd International ASSHH Conference, Stellenbosch, South Africa, 6-9 July 2015.

ART With Weekends Off Is Noninferior to Continuous ART in Young People on EFV+2NRTI

2015

Authors: Karina M. Butler on behalf of the BREATHER trial team

Published in: CROI 2015, Seattle, USA, Feb 23 -26 2015.

Abstract For HIV-1 infected young people (YP) facing lifelong ART, short cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity and better adherence, as well as cost savings.

HIV-1 Drug Resistance and Second-line Treatment in Children Randomized to Switch at Low versus Higher RNA Thresholds

2015

Authors: Harrison L, Melvin A, Fiscus S, et al; PENPACT-1 (PENTA 9PACTG 390) Study Team.

Published in: J Acquir Immune Defic Syndr. 2015;70(1):42-53

Background The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy (ART). Using PENPACT-1 data, we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold.

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