Efficacy and safety of tenofovir disoproxil fumarate in pregnancy for the prevention of vertical transmission of HBV infection.

Abstract

AIM:

To evaluate the effects of tenofovir disoproxil fumarate (TDF) use during late pregnancy to reduce hepatitis B virus (HBV) transmission in highly viremic mothers.

METHODS:

This retrospective study included 45 pregnant patients with hepatitis B e antigen (+) chronic hepatitis B and HBV DNA levels > 10⁷ copies/mL who received TDF 300 mg/d from week 18 to 27 of gestation (n = 21). Untreated pregnant patients served as controls (n = 24). All infants received 200 IU of hepatitis B immune globulin (HBIG) within 24 h postpartum and 20 μg of recombinant HBV vaccine at 4, 8, and 24 wk. Perinatal transmission rate was determined by hepatitis B surface antigen and HBV DNA results in infants at week 28.

RESULTS:

At week 28, none of the infants of TDF-treated mothers had immunoprophylaxis failure, whereas 2 (8.3 %) of the infants of control mothers had immunoprophylaxis failure (P = 0.022). There were no differences between the groups in terms of adverse events in mothers or congenital deformities, gestational age, height, or weight in infants. At postpartum week 28, significantly more TDF-treated mothers had levels of HBV DNA < 250 copies/mL and normalized alanine aminotransferase compared with controls (62% vs none, P < 0.001; 82% vs 61%, P = 0.012, respectively).

CONCLUSION:

TDF therapy during the second or third trimester reduced perinatal transmission rates of HBV and no adverse events were observed in mothers or infants.

• Authors: Mustafa Kemal Celen, Duygu Mert, Müzeyyen Ay, Tuba Dal, Safak Kaya, Necmettin Yildirim, Serda Gulsun, Tunga Barcin, Sevgi Kalkanli, Mehmet Sinan Dal, Celal Ayaz
• Journal: World journal of gastroenterology (World J Gastroenterol) Vol. 19 Issue 48 Pg. 9377-82 (Dec 28 2013) ISSN: 2219-2840 [Electronic] United States
• PMID: 24409065 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Antiviral Agents
• Biomarkers
• DNA, Viral
• Hepatitis B Vaccines
• Hepatitis B e Antigens
• Immunoglobulins
• Organophosphonates
• Tenofovir
• Adenine
• hepatitis B hyperimmune globulin

Topics

• Adenine (adverse effects, analogs & derivatives, therapeutic use)
• Antiviral Agents (adverse effects, therapeutic use)
• Biomarkers (blood)
• DNA, Viral (blood)
• Female
• Hepatitis B (diagnosis, drug therapy, transmission)
• Hepatitis B Vaccines (administration & dosage)
• Hepatitis B e Antigens (blood)
• Hepatitis B virus (drug effects, genetics, immunology)
• Humans
• Immunization Schedule
• Immunoglobulins (administration & dosage)
• Infant
• Infant, Newborn
• Infectious Disease Transmission, Vertical (prevention & control)
• Organophosphonates (adverse effects, therapeutic use)
• Pregnancy
• Pregnancy Complications, Infectious (diagnosis, drug therapy, virology)
• Pregnancy Outcome
• Pregnancy Trimester, Second
• Pregnancy Trimester, Third
• Retrospective Studies
• Tenofovir
• Time Factors
• Treatment Outcome
• Turkey
• Viral Load