Efficacy and safety of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in preventing HBV vertical transmission of high maternal viral load

Li, Baijun; Liu, Zhaozhe; Xing, Liu; Liu, Dongchun; Duan, Mingyu; Gu, Ye; Liu, Qiong; Ma, Qiang; Wei, Yushi; Wang, Yan

doi:10.1007/s12072-021-10235-1

Cited by 19 publications

(27 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…While there are no TAF switching studies in pregnant women, studies of TAF during pregnancy have been conducted. Three studies that evaluated TAF treatment in pregnant women reported that TAF could effectively reduce maternal HBV transmission with no observed safety concerns, 77 , 78 , 79 suggesting that TAF switching may be appropriate in these patients, although it is not indicated for such use. ETV and TDF have been studied in children with CHB, 3 , 4 , 5 while TAF is currently under investigation in this setting.…”

Section: Discussion and Clinical Implicationsmentioning

confidence: 99%

Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

Lim

Seto

Kurosaki

et al. 2022

Aliment Pharmacol Ther

View full text Add to dashboard Cite

Summary Background The nucleos(t)ide analogues (NAs) entecavir (ETV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are preferred treatment options for patients with chronic hepatitis B infection (CHB). However, resistance to ETV has been reported, especially with prior exposure to other NAs, and long‐term TDF treatment has been associated with decline in renal function and loss of bone mineral density in some patients. Consequently, TAF may be preferable to ETV, TDF or other NAs in specific circumstances such as in patients with risk of bone or renal complications, elderly patients or those with previous NA experience. Aim To provide a summary of the available efficacy and safety data following switch to TAF from other NAs in patients with CHB in clinical studies and real‐world settings. Methods Literature searches were performed on PubMed and abstracts from three major international liver congresses between 2019 and 2021. Studies that included efficacy and/or safety data for patients with CHB switching from any NA to TAF were selected. Results Thirty‐six papers and abstracts were included in this narrative review. Switching from TDF to TAF maintained or improved virological and biochemical responses with improved bone and renal safety. Switching from ETV or other NAs to TAF maintained or improved virological and biochemical responses and varying results for bone and renal safety. Conclusions Switching to TAF appears to maintain or improve virological, biochemical and bone‐ and renal‐related safety outcomes. These data support the concept of switching to TAF in some patients with CHB based on their individual circumstances.

show abstract

Section: Discussion and Clinical Implicationsmentioning

confidence: 99%

Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

Lim

Seto

Kurosaki

et al. 2022

Aliment Pharmacol Ther

View full text Add to dashboard Cite

show abstract

“…For maternal viral load reduction, all studies on TAF indicated that the mean of serum HBV DNA viral load significantly decreased following treatment 17,19–21. In Ding’s study, the mean maternal baseline HBV DNA of the TAF group was 7.78±0.72 Log10 IU/mL 19.…”

Section: Literature Reviews For Tdf and Taf Therapymentioning

confidence: 94%

“…Currently, 4 published studies (1 RCT and 3 cohort studies) have reported the outcomes of TAF for preventing MTCT of HBV (Table 1 and Sup 4. Table S4-6, Supplemental Digital Content 1, http://links.lww.com/JCG/A900) in China for highly viremic mothers 17,19–21. All studies provided the appropriate infant immunoprophylaxis with a timely dose of the HBIG and HBV vaccines.…”

Section: Literature Reviews For Tdf and Taf Therapymentioning

confidence: 99%

The Use of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide for Preventing Vertical Transmission of Hepatitis B

Zhu

Park

Deng

et al. 2022

Journal of Clinical Gastroenterology

View full text Add to dashboard Cite

Background: Mother-to-child transmission (MTCT) of hepatitis B virus may occur in highly viremic mothers despite the infants receiving appropriate immunoprophylaxis. We aimed to review tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) data for preventing MTCT. Methods and Data Selection: We performed a systematic review between January 1, 2015 and December 31, 2021 on PUBMED, EMBASE, Cochrane, CNKI, and Wanfang databases. Data was extracted from randomized controlled trials or cohort studies in English or Chinese. The outcomes of interest included the efficacy and safety of TDF versus TAF or TDF/TAF versus placebo for preventing MTCT (PROSPERO registration: CRD42021256656). Results: Data from forty-three studies (13 randomized controlled trials, 30 nonrandomized studies) were included in the review. All infants in the studies received appropriate immunoprophylaxis. Among 3656 highly viremic mothers treated with TDF, hepatitis B virus DNA suppression to the levels <200,000 IU/mL at delivery was achieved in 34% to 100% of mothers. MTCT rates were 0 to 5% and 2 to 83% in mothers treated with TDF and in those who received no treatment, respectively. Congenital malformation rates were 0 to 2.1% in the TDF groups, which did not differ from the nontreated groups. Similar findings were reported in 4 studies that enrolled 326 mothers for maternal TAF therapy, resulting in 0% of MTCT and 0% infant malformation. All studies observed that TDF or TAF maternal therapy reduced MTCT rates significantly without safety concerns when compared with untreated groups, except for 1 RCT that failed the therapeutic endpoint. Conclusions: TDF is well established for preventing MTCT in highly viremic mothers, whereas TAF may become an option as data emerges.

show abstract

“…Therefore, the treatment of lamivudine or telbivudine during pregnancy will not be covered in this article. Although one RCT and two cohort studies on maternal tenofovir alafenamide (TAF) therapy for PMTCT have been published [23][24][25][26][27] , the quality of the RCT was low due to the small sample size [24] . The current review aimed to highlight the investigational process for tenofovir disoproxil fumarate (TDF) therapy, honor Dr. Martin's contributions, summarize the updated pieces of evidence, and discuss the advances of maternal TDF therapy for the prevention of HBV transmission.…”

Section: Introductionmentioning

confidence: 99%

The role of tenofovir disoproxil fumarate for preventing vertical transmission of hepatitis B

Pan

2022

Antiviral Therapy

View full text Add to dashboard Cite

Background Since immunoprophylaxis failure can occur if maternal serum hepatitis B virus (HBV) DNA levels are >200,000 IU/ml, tenofovir disoproxil fumarate (TDF) therapy has been investigated for preventing mother to child transmission (PMTCT). Methods A literature search for maternal TDF therapy for PMTCT between 1/1/2015 and 7/1/21 on PUBMED, EMBASE, Cochrane, CNKI, and Wanfang databases was performed. Data from RCTs in English or Chinese were extracted and reviewed. The outcomes of interest included the efficacy and safety of TDF versus placebo for PMTCT. Results Among 11 RCTs identified from the databases, the risk-of-bias was low. All studies demonstrated that maternal TDF therapy initiated from the second or third trimester for highly viremic chronic hepatitis B mothers is highly effective and safe in the PMTCT of HBV, except one RCT performed in Thailand which showed no therapeutic advantage on TDF treatment versus placebo for PMTCT (0% vs 3% transmission). Recent emerging data suggest that maternal TDF therapy initiated at the 2nd or early 3rd trimester in mothers with HBV DNA >200,000 IU/ml achieved viremic control before delivery. In the 4-year long follow-up study for maternal TDF therapy, there were no impacts on infants’ physical growth, psychological or mental development, and bone mineral density after fetal exposure to TDF. In the light of updated efficacy and safety data from RCTs, an algorithm was proposed. The approaches in resource-limit areas were discussed. Conclusions TDF is safe for both mothers and infants as the preferred therapy for PMTCT in highly viremic mothers. TDF should be initiated at the second or early third trimester in the combination of the appropriate infants’ immunoprophylaxis.

show abstract

Efficacy and safety of tenofovir disoproxil fumarate and tenofovir alafenamide fumarate in preventing HBV vertical transmission of high maternal viral load

Cited by 19 publications

References 23 publications

Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

Review article: switching patients with chronic hepatitis B to tenofovir alafenamide—a review of current data

The Use of Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide for Preventing Vertical Transmission of Hepatitis B

The role of tenofovir disoproxil fumarate for preventing vertical transmission of hepatitis B

Contact Info

Product

Resources

About