PENTA 16 (BREATHER)

18

Jul, 2015

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

 

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.

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18

Jul, 2015

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

 

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.

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23

Feb, 2015

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

 

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.

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1

Jan, 2015

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

 

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.

Methods PENPACT-1 had a 2 × 2 factorial design, randomizing HIV-infected children to start protease inhibitor (PI) versus nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART, and switch at a 1000 copies/mL versus 30,000 copies/mL threshold. Switch criteria were not achieving the threshold by week 24, confirmed rebound above the threshold thereafter, or Center for Disease Control and Prevention stage C event. Resistance tests were performed on samples ≥1000 copies/mL before switch, resuppression, and at 4-years/trial end.

Results Sixty-seven children started PI-based ART and were randomized to switch at 1000 copies/mL (PI-1000), 64 PIs and 30,000 copies/mL (PI-30,000), 67 NNRTIs and 1000 copies/mL (NNRTI-1000), and 65 NNRTI and 30,000 copies/mL (NNRTI-30,000). Ninety-four (36%) children reached the 1000 copies/mL switch criteria during 5-year follow-up. In 30,000 copies/mL threshold arms, median time from 1000 to 30,000 copies/mL switch criteria was 58 (PI) versus 80 (NNRTI) weeks (P = 0.81). In NNRTI-30,000, more nucleoside reverse transcriptase inhibitor (NRTI) resistance mutations accumulated than other groups. NNRTI mutations were selected before switching at 1000 copies/mL (23% NNRTI-1000, 27% NNRTI-30,000). Sixty-two children started abacavir + lamivudine, 166 lamivudine + zidovudine or stavudine, and 35 other NRTIs. The abacavir + lamivudine group acquired fewest NRTI mutations. Of 60 switched to second-line, 79% PI-1000, 63% PI-30,000, 64% NNRTI-1000, and 100% NNRTI-30,000 were <400 copies/mL 24 weeks later.

Conclusions Children on first-line NNRTI-based ART who were randomized to switch at a higher virologic threshold developed the most resistance, yet resuppressed on second-line. An abacavir + lamivudine NRTI combination seemed protective against development of NRTI resistance.

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