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Tenofovir alafenamide to prevent perinatal hepatitis B transmission in mothers with high viral load: a multicenter, prospective, observational study.
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TAF and TDF Prevent HBV Transmission From Mothers With High HBV Loads in China
AASLD The Liver Meeting Digital Experience, November 13-16, 2020
Mark Mascolini
Both tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF) taken by pregnant women with an HBV load above 200,000 IU/mL prevented HBV transmission to all newborns in a matched comparison of 232 women in China [1]. All infants also received standard immunoprophylaxis against HBV: 100 IU of hepatitis B immunoglobin and 3 individual 10-μg doses of recombinant HBV vaccine within 12 hours of birth, at 1 month, and at 6 months. TAF also prevented mother-to-child HBV transmission in a separate 71-mother national multicenter study in China [2].
The TAF-TDF comparison enrolled 20- to 40-year-old women pregnant for more than 24 weeks. They all had HBV DNA above 200,000 IU/mL and normal alanine aminotransferase (ALT). The study excluded women who received anti-HBV therapy or treatment to lower ALT and women with evidence of hepatocellular carcinoma, cirrhosis, another hepatitis virus, HIV, or systemic disorders.
Researchers matched 116 mother who chose TDF for prophylaxis to 116 who chose TAF by age (within 1 year), gestational age (within 1 week), and HBeAg status (HBeAg indicates replicating virus that can be transmitted). Women in each matched pair started TDF or TAF within 1 week. Women taking TAF bore 117 infants, and women taking TDF bore 116. All 232 women completed their full course of TAF or TDF from baseline to delivery.
Age averaged a few months over 29 years in both the TAF and TDF group, while gestational age averaged 28.2 weeks in both groups. The groups did not differ in proportions bearing their first child (about three quarters) or in hemoglobin, platelets, ALT, total bilirubin, or creatinine. Fifteen women taking TAF (12.9%) and 14 taking TDF (12.1%) had premature rupture of membranes.
At delivery and 3 and 6 months after delivery, 92% of women in both groups were positive for HBeAg. HBV DNA at delivery averaged 3.5 IU/mL in the TAF group and 3.4 IU/mL in the TDF group. HBV DNA averaged 7.7 IU/mL at 3 months in both the TAF and TDF groups and 7.8 IU/mL at 6 months in both groups. Among infant parameters, the TAF and TDF groups did not differ in weight, height, head circumference, or Apgar score at 1 minute. No infant in either group had congenital defects or malformation. Physical and neurologic development were normal in both groups.
At infant 7-month visits, no infant tested positive for HBsAg in either group, a result indicating none of them had current HBV infection. Almost all infants in both groups tested positive for anti-HBs at 7 months.
For mothers, TAF and TDF had similarly good safety profiles. No mothers stopped TAF because of adverse events. The most frequent TAF adverse event was nausea in 19%.
References
1. Zeng QL, Yu Z, Wang FS. Tenofovir alafenamide to prevent perinatal hepatitis B transmission in mothers with high viral load: a multicenter, prospective, observational study. AASLD The Liver Meeting Digital Experience, November 13-16, 2020. Abstract 160.
2. Ding Y, Cao L, Zhu L, et al. Tenofovir alafenamide fumarate therapy for the prevention of hepatitis B vertical transmission in highly viremic mothers with chronic hepatitis B. AASLD The Liver Meeting Digital Experience, November 13-16, 2020. Abstract 20. (Reported separately by NATAP.)
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