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Antiviral prophylaxis to prevent perinatal transmission of HBV in Thailand

Award Number: U01HD071889
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2012
PERIOD OF PERFORMANCE END DATE: 08/31/2017

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Antiviral prophylaxis to prevent perinatal transmission of HBV in Thailand - DESCRIPTION (provided by applicant): The proposed study is a phase III, multicenter, controlled, double blind, randomized clinical trial in Thailand to compare the efficacy, safety and tolerance of each of two drugs, tenofovir and lamivudine, versus placebo, given to hepatitis B (HB) chronically infected pregnant women with a positive HBeAg test and normal liver function tests, from 28 weeks' gestation until two months postpartum to prevent perinatal transmission of hepatitis B virus (HBV). Chronic HBV, complicated by cirrhosis and hepatocellular carcinoma (HCC), is the 10th leading cause of death worldwide. About 7% of Thai adults are HBsAg carriers. Universal immunization programs have dramatically reduced the prevalence of infection wherever they have been implemented. Infant HBV immunization and HB immunoglobulin administered at birth effectively prevent most transmission from HBV infected mothers but, despite this active and passive immunization, about 12% of HBV highly viremic mothers transmit the virus to their infants. The antigen HBe (HBeAg) is a marker of high replication. Studies have suggested that antiviral treatment at the end of pregnancy and in the postpartum can reduce the risk of transmission to the child. A potential limitation to this approach is the risk of hepatic disease exacerbation (flare) following discontinuation of antiviral treatment, which has not been properly evaluated. No randomized clinical trials have adequately demonstrated the efficacy and safety of antiviral treatment and this approach is not recommended by the Associations for the Study of Liver Diseases. We hypothesize that tenofovir or lamivudine can decrease HBV viral load in HBV infected pregnant women and therefore the risk of in utero, intrapartum and postpartum transmission before infants are protected by passive-active immunization. We also hypothesize that only moderate flares will be observed after discontinuation of a short antiviral course (5 months). While the primary objective of the study is to assess the efficacy of tenofovir or lamivudine versus placebo for the prevention of perinatal transmission, an important secondary objective is the assessment of the risk of postpartum hepatic disease exacerbation. HBsAg positive women will be enrolled if they have an HBeAg positive test and ALT 30 U/L. They will be randomized to receive tenofovir or lamivudine or placebo from 28 weeks of pregnancy until 2 months postpartum. Within 2 years, 588 women and their infants will be enrolled in 8 sites of the PHPT network in Thailand, where the teams have gained considerable experience in conducting trials for the prevention of mother to child transmission of HIV over the past 15 years. Mothers and infants will be followed until one year postpartum. The primary endpoint will be the detection of HBsAg and HBV DNA at six months of life. An interim analysis will be conducted when half of the outcomes are available. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.


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: 2018 ( Subtotal = -$7,648 )
2018	2016	INSTITUT RECHERCHE POUR LE DEVELOPPEMENT	CS90009 RESIDENCE LE SEXTANT	MARSEILLE	PROVENCE-ALPES-COTE D'AZUR	13002		FRA	Child Health and Human Development Extramural Research	002	4	1/5/2018	SUPPLEMENT FOR EXPANSION	$0
2018	2015	INSTITUT RECHERCHE POUR LE DEVELOPPEMENT	CS90009 RESIDENCE LE SEXTANT	MARSEILLE	PROVENCE-ALPES-COTE D'AZUR	13002		FRA	Child Health and Human Development Extramural Research	004	4	3/20/2018	NON-COMPETING CONTINUATION	$286,747
2018	2015	INSTITUT RECHERCHE POUR LE DEVELOPPEMENT	CS90009 RESIDENCE LE SEXTANT	MARSEILLE	PROVENCE-ALPES-COTE D'AZUR	13002		FRA	Child Health and Human Development Extramural Research	001	4	1/5/2018	NON-COMPETING CONTINUATION	-$294,395
2018	2014	INSTITUT RECHERCHE POUR LE DEVELOPPEMENT	CS90009 RESIDENCE LE SEXTANT	MARSEILLE	PROVENCE-ALPES-COTE D'AZUR	13002		FRA	Child Health and Human Development Extramural Research	003	3	3/20/2018	NON-COMPETING CONTINUATION	$333,131
2018	2014	INSTITUT RECHERCHE POUR LE DEVELOPPEMENT	CS90009 RESIDENCE LE SEXTANT	MARSEILLE	PROVENCE-ALPES-COTE D'AZUR	13002		FRA	Child Health and Human Development Extramural Research	000	3	1/5/2018	NON-COMPETING CONTINUATION	-$333,131
														Subtotal = -$7,648

Issue Date FY: 2016 ( Subtotal = $100,000 )
2016	2016	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	000	4	6/30/2016	SUPPLEMENT FOR EXPANSION	$100,000
														Subtotal = $100,000

Issue Date FY: 2015 ( Subtotal = $482,549 )
2015	2015	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	001	4	9/17/2015	NON-COMPETING CONTINUATION	$294,395
2015	2015	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	000	3	5/18/2015	SUPPLEMENT FOR EXPANSION	$188,154
														Subtotal = $482,549

Issue Date FY: 2014 ( Subtotal = $479,336 )
2014	2014	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	002	3	8/25/2014	NON-COMPETING CONTINUATION	$479,336
2014	2013	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	001	2	1/17/2014	EXTENSION WITH OR WITHOUT FUNDS	$457,666
2014	2013	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	000	2	1/15/2014	EXTENSION WITH OR WITHOUT FUNDS	-$457,666
														Subtotal = $479,336

Issue Date FY: 2013 ( Subtotal = $457,666 )
2013	2013	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	001	2	9/11/2013	EXTENSION WITH OR WITHOUT FUNDS	$457,666
2013	2013	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	003	2	1/17/2014	EXTENSION WITH OR WITHOUT FUNDS	$457,666
2013	2013	INSTITUT DE RECHERCHE POUR LE DEVELOPPEMENT	213 RUE LA FAYETTE	PARIS				FRA	Child Health and Human Development Extramural Research	002	2	1/15/2014	EXTENSION WITH OR WITHOUT FUNDS	-$457,666
2013	2012	INSTITUT DE RECHERCHES POUR LE DEVELOPPEMENT	44 BOULEVARD DE DUNKERQUE	MARSEILLE 13002				FRA	Child Health and Human Development Extramural Research	000	1	8/20/2013	NEW	$0
														Subtotal = $457,666

Issue Date FY: 2012 ( Subtotal = $461,199 )
2012	2012	INSTITUTE OF RESEARCH AND DEVELOPMENT	44, BOULEVARD DUNKERQUE	MARSEILLE				FRA	Child Health and Human Development Extramural Research	000	1	8/30/2012	NEW	$461,199
														Subtotal = $461,199

Grand Total All Awards = $1,973,102

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Antiviral prophylaxis to prevent perinatal transmission of HBV in Thailand

Award Number: U01HD071889

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2012

PERIOD OF PERFORMANCE END DATE: 08/31/2017

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