Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women

Официальное название

Efficacy of Tenofovir Disoproxil on Mother-to-child Transmission of HBV in Tokombéré, Cameroon in Pregnant Women Infected With Hepatitis B Virus (HBeAg Positive or With a High Viral Load) and Whose Newborns Had Been Vaccinated at Birth

Обзор

Pregnant women with HBeAg-positive viral hepatitis b or high viral load will receive Tenofovir disoproxil fumarate (TDF) from the 28th week of amenorrhoea until 6 weeks after delivery. Their newborns will receive the hepatitis B vaccine, starting with one dose at birth and followed by three booster doses, according to the Expanded Programme on Immunisation. The investigators hypothesise that a short course of TDF could greatly reduce the risk of HBV MTCT in pregnant women at high risk of MTCT (HBeAg positive or with high viral load).

Подробное описание

This is a prospective, single-arm, open-label, descriptive, phase IV clinical trial in HBsAg and HBeAg positive pregnant women. Eligible pregnant women will receive 245 mg of tenofovir disoproxil fumarate once daily from 28 weeks of pregnancy until 6 weeks after delivery. Newborns will receive the hepatitis B vaccine, starting with one dose at birth, followed by three booster doses, in accordance with the expanded programme of vaccination.

The study aims to show that the addition of maternal antiviral treatment to vaccination at birth followed by three booster doses can be favourably considered in the context where vaccination alone is not sufficient to prevent transmission of the hepatitis B virus from mother to child. A total of 150 pregnant women will be included in the Tokombéré district.

Вмешательства

• Препарат Fumarate, Tenofovir Disoproxil
  all participants receive the intervention

Первичные конечные точки

• Proportion of children with HBsAg positive at 9-12 months of life (W36 - W48) in the study population, [Срок оценки: measured between 36 and 48 weeks of life of the child of the mothers included in the study]

Вторичные конечные точки (7)

• Proportion of eligible women who accepted the intervention among eligible women offered the intervention (acceptance rate) [Срок оценки: measured from 7 months of pregnancy to 8 weeks postpartum]
• Compliance with treatment [Срок оценки: from 28 weeks of pregnancy to 8 weeks postpartum]
• Progression of viral load [Срок оценки: measured from 24 weeks of pregnancy until the end of treatment]
• Estimate the protection rate of children with anti-HBs antibody level > 10 mIU/mL [Срок оценки: measured between 36 and 48 weeks of life of the child of the mothers included in the study]
• Assess the clinical and biological tolerance of TDF administration in mothers and children [Срок оценки: measured from 28 weeks of pregnancy until the end of treatment]
• Assess the rate of women requiring extended treatment after delivery [Срок оценки: Assess at 12 and 24 weeks postpartum]
• To assess the cost-effectiveness of the intervention (compared to vaccination alone, without hepatitis B immune globulin (Ig-anti HBV)) [Срок оценки: To evaluate throughout the study]

Критерии участия

Критерии включения

• Pregnant women with a term of less than 24 weeks of amenorrhea;
• HBsAg positive ;
• HBeAg positive or HBeAg negative with a high viral load ( > 200 000 UI/ml) ;
• 16 years old or more on the inclusion day ;
• Signature of free and informed consent (for pregnant women aged 16 to 21, the participant's consent as well as the authorization of a parent/adult husband/ legal tutor will be collected) which also includes consent for the children

Критерии исключения

• HIV co-infection;
• Women treated for HBV;
• Creatinine clearance <30 ml / min;
• Suspicion of poor monitoring of children's vaccination schedule for HBV (vaccination at birth + boosters);
• Disease or treatment contraindicating the taking of TDF.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Cameroon · 1 центр

• Hôpital Privé de Tokombéré — Tokonbéré

Идентификаторы

NCT: NCT05403047 · ANRS 12417 TOPCHIB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗