Early Start Of Tenofovir Treatment Achieves Better Viral Suppression In Pregnant Women With A High HBV Viral Load: A Real-World Prospective Study

Abstract

Purpose: To investigate whether tenofovir disoproxil fumarate (TDF) treatment that started from the second trimester had an advantage over TDF treatment that started from the third trimester.

Patients and methods: Twenty 35-year-old pregnant women with hepatitis B virus (HBV) DNA >2×106 IU/mL were prospectively enrolled in this study. All participants were divided into two subgroups: the second trimester group who started TDF treatment at 24-27 weeks and the third trimester group who started TDF treatment at 28-30 weeks. The primary outcome was the change in serum HBV DNA level from baseline to delivery. Each parameter was tested every 4 weeks from TDF initiation to 3 months postpartum.

Results: There were 80 pregnant women in the second trimester group and 49 pregnant women in the third trimester group. The decline in HBV DNA from baseline to delivery was more obvious in the second trimester group (4.8±1.2 log10 IU/mL) than that in the third trimester group (4.3±1.1 log10 IU/mL, p=0.041). The downward shift of haemoglobin (HB) from baseline to delivery was greater in the second trimester group (10.6±10.7 g/L) than in the third trimester group (6.3±12.3 g/L, p=0.041). The decline in HBV DNA from baseline to delivery was linearly related to the start of TDF treatment from the second trimester (β=0.50 and 95% CI: 0.26-0.75, p<0.001). There were no significant differences between the two groups regarding HBV serologic markers and safety indicators.

Conclusion: Starting TDF treatment from the second trimester achieved better viral suppression than starting TDF treatment from the third trimester in highly viraemic pregnant women without increasing additional adverse reactions. HB level needed frequent monitoring during treatment to avoid anaemia.

Registry number: Clinical Trial No. NCT02719808.

Keywords: efficacy; safety; second trimester; tenofovir disoproxil fumarate; third trimester.

Conflict of interest statement

The authors report no conflicts of interest in this work.

© 2019 Gao et al.

Figures

Figure 1

The screening process of study population. Abbreviations: HBsAg, hepatitis B surface antigen; HBeAg, hepatitis Be antigen; HBV, hepatitis B virus; DNA, deoxyribonucleic acid; TDF, tenofovir disoproxil fumarate.

Figure 2

The dynamic changes in the level of HBV DNA. Notes:p1 was calculated to test whether the effect of the group (sencond trimester vs third trimester) is significant in the mixed linear model. p2 was calculated to test whether the effect of follow-up time is significant in the mixed linear model.

Figure 3

The dynamic changes in the level of HBsAg (A), HBeAg (B), HBeAb (C) and HBcAb (D). Notes:p1 was calculated to test whether the effect of the group (sencond trimester vs third trimester) is significant in the mixed linear model. p2 was calculated to test whether the effect of follow-up time is significant in the mixed linear model. Abbreviations: HBsAg, hepatitis B surface antigen; HBeAg, hepatitis Be antigen; HBeAb, hepatitis Be antibody; HBcAb, hepatitis B core antibody.

Figure 4

The dynamic changes of safety indicators: ALT (A), AST (B), ALB (C), HB (D), BUN (E), Cr (F). Notes:p1 was calculated to test whether the effect of the group (sencond trimester vs third trimester) is significant in the mixed linear model. p2 was calculated to test whether the effect of follow-up time is significant in the mixed linear model. Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALB, albumin; HB, haemoglobin; BUN, blood urea nitrogen; Cr, creatinine.