Tenofovir Alafenamide for Pregnant Chinese Women With Active Chronic Hepatitis B: A Multicenter Prospective Study,Clinical Gastroenterology and Hepatology

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Tenofovir Alafenamide for Pregnant Chinese Women With Active Chronic Hepatitis B: A Multicenter Prospective Study
Clinical Gastroenterology and Hepatology ( IF 12.6 ) Pub Date : 2021-12-11 , DOI: 10.1016/j.cgh.2021.12.012
Qing-Lei Zeng ₁ , Hong-Xu Zhang ₂ , Ji-Yuan Zhang ₃ , Shuo Huang ₁ , Wei-Zhe Li ₁ , Guang-Ming Li ₄ , Ya-Jie Pan ₁ , Ying-Hua Feng ₅ , Zhi-Qin Li ₁ , Guo-Fan Zhang ₆ , Jiang-Hai Xu ₇ , Wan-Bao Lin ₈ , Guang-Hua Xu ₉ , Na Liu ₉ , Guo-Qiang Zhang ₁₀ , Guo-Tao Li ₁₀ , Wei Li ₁₁ , Yan-Li Zeng ₁₁ , Ning Song ₁₂ , Meng Wang ₁₃ , Da-Wei Zhang ₃ , Zhi-Min Chen ₁₄ , Guang-Lin Cui ₁₅ , Juan Li ₁ , Jun Lv ₁ , Yan-Min Liu ₁ , Hong-Xia Liang ₁ , Chang-Yu Sun ₁ , Yi-Hua Zhou ₁₆ , Zu-Jiang Yu ₁ , Fu-Sheng Wang ₃

Affiliation

Department of Infectious Diseases and Hepatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province.
Department of Infectious Diseases, Luohe Central Hospital, Luohe, Henan Province.
Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, National Clinical Research Center for Infectious Diseases, Beijing.
Department of Hepatology, The Sixth People's Hospital of Zhengzhou City, Zhengzhou, Henan Province.
Department of Hepatology, The Sixth People's Hospital of Kaifeng City, Kaifeng, Henan Province.
Department of Infectious Diseases, The First Affiliated Hospital of Nanyang Medical College, Nanyang, Henan Province.
Department of Hepatology, The Fifth People's Hospital of Anyang City, Anyang, Henan Province.
Department of Infectious Diseases, Xinyang Central Hospital, Xinyang, Henan Province.
Department of Infectious Diseases, The Affiliated Hospital of Yan'an University, Yan'an, Shaanxi Province.
Department of Infectious Diseases, Luoyang Central Hospital, Luoyang, Henan Province.
Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan Province.
Center for Reproductive Medicine, Henan Key Laboratory of Reproduction and Genetics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province.
Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province.
Department of Obstetrics, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province.
Department of Clinical Laboratory, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province.
Department of Experimental Medicine and Jiangsu Key Laboratory for Molecular Medicine, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu Province, China.

Background & Aims

Data on long-term tenofovir alafenamide (TAF) therapy for pregnant women with active chronic hepatitis B (CHB) (immune clearance and reactivation phases, currently and previously diagnosed) and their infants are lacking.

Methods

Pregnant women with active CHB treated with TAF and tenofovir disoproxil fumarate (TDF) were enrolled in this multicenter prospective study, and infants received immunoprophylaxis. The primary outcomes were rates of adverse (safety) events in pregnant women and defects in infants and fetuses. The secondary outcomes were virologic responses in pregnant women, infants’ safety, hepatitis B surface antigen (HBsAg) status, and growth conditions.

Results

One hundred three and 104 pregnant women were enrolled and 102 and 104 infants were born in the TAF and TDF groups, respectively. In the TAF group, the mean age, gestational age, alanine aminotransferase level, and viral loads at treatment initiation were 29.3 years, 1.3 weeks, 122.2 U/L, and 5.1 log₁₀ IU/mL, respectively. TAF was well-tolerated, and the most common adverse event was nausea (29.1%) during a mean of 2 years of treatment. Notably, 1 (1.0%) TAF-treated pregnant woman underwent induced abortion due to noncausal fetal cleft lip and palate. No infants in either group had birth defects. In the TAF group, the hepatitis B e antigen seroconversion rate was 20.7% at postpartum month 6, infants had normal growth parameters, and no infants were positive for HBsAg at 7 months. The TDF group had comparable safety and effectiveness profiles.