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A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV coinfection (the REACT Study)

Award Number: R01DA040506
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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DESCRIPTION (provided by applicant): Increasing numbers of hepatitis C (HCV) transmissions are being observed in high-risk groups including young people who inject drugs (PWID) and HIV positive men who have sex with men (MSM) causing major international concern. Novel highly effective oral directly acting antiviral (DAA) drugs promise hope for the treatment of HCV at an individual and population level, yet major barriers and uncertainty exist regarding their use in marginalised groups. Early engagement, testing and treating these populations, has significant potential to limit HCV transmission and ongoing epidemics, yet the importance of adherence, risk behaviour change and the potential for subsequent reinfection in the era of interferon free treatments are currently poorly understood. In prior NIH funded projects using interferon-based therapies, over 200 PWID/HIV positive MSM with recent HCV were engaged and treated demonstrating the feasibility, safety and efficacy of treatment in these high risk groups. In this proposed project a unique international collaboration of investigators (termed the REcently ACquired HCV Trials (REACT) network) is utilised to address critical current questions. A randomised clinical trial involving 250 HIV positive and negative subjects with recent HCV will be performed to evaluate the effectiveness of short (6 week) course therapy versus standard (12 week) course therapy with the DAA combination sofosbuvir/GS5816. During therapy novel methods of adherence monitoring including electronic blister packs and therapeutic drug monitoring will be used to assess adherence to treatment and its impact on treatment outcome. Subjects will be followed for up to 2 years post treatment allowing the most extensive evaluation of reinfection incidence post treatment in individuals with recent HCV and in-depth evaluation through behavioural questionnaires of the impact of engagement and treatment at this stage on risk reduction and drug and sexual practice change. All analyses will be examined in both HIV positive and negative groups. Serum and cells will be stored throughout to allow assessment of immunological responses to HCV following DAA treatment within the first year of infection and to gain unique insights into the immune response surrounding HCV clearance and reinfection. These specimens will also expand extensive storage banks from subjects with recent HCV treated in the interferon-era enhancing a valuable resource. Findings from this project will provide recommendations to guide clinicians and public health policy in the effective management of HIV positive and negative individuals and populations at risk for, or recently infected with HCV.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2019	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Drug Use and Addiction Research Programs	000	5	11/23/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON				AUS	Drug Use and Addiction Research Programs	000	5	12/13/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $572,496 )
2019	2019	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Drug Use and Addiction Research Programs	000	5	6/19/2019	NON-COMPETING CONTINUATION	$572,496
														Subtotal = $572,496

Issue Date FY: 2018 ( Subtotal = $964,605 )
2018	2018	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Drug Use and Addiction Research Programs	000	4	7/18/2018	NON-COMPETING CONTINUATION	$964,605
														Subtotal = $964,605

Issue Date FY: 2017 ( Subtotal = $1,072,560 )
2017	2017	UNIVERSITY OF NEW SOUTH WALES	HIGH ST	KENSINGTON	NSW	2052		AUS	Drug Use and Addiction Research Programs	000	3	7/18/2017	NON-COMPETING CONTINUATION	$1,072,560
														Subtotal = $1,072,560

Issue Date FY: 2016 ( Subtotal = $641,939 )
2016	2016	UNIVERSITY OF NEW SOUTH WALES	14 BARKER STREET 2052	SYDNEY				AUS	Drug Use and Addiction Research Programs	000	2	7/27/2016	NON-COMPETING CONTINUATION	$641,939
														Subtotal = $641,939

Issue Date FY: 2015 ( Subtotal = $476,756 )
2015	2015	UNIVERSITY OF NEW SOUTH WALES	14 BARKER STREET 2052	SYDNEY				AUS	Drug Use and Addiction Research Programs	000	1	9/25/2015	NEW	$476,756
														Subtotal = $476,756

Grand Total All Awards = $3,728,356

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A randomised study of interferon-free treatment for recently acquired hepatitis C in people who inject drugs and people with HIV coinfection (the REACT Study)

Award Number: R01DA040506

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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