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Tenofovir to prevent Hepatitis B transmission in mothers with high viral load. N Engl J Med. All the infants received immunoprophylaxis. The primary outcomes were the rates of mother-to-child transmission and birth defects.

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Evidence-based Medicine Viewpoint. Relevance : Perinatal transmission of Hepatitis B infection is associated with unpleasant consequences for individuals as well as the society — the former because transmission from mothers with active viral replication is associated with high probability of chronicity in the affected offspring, and the latter because it contributes to the pool of chronic carriers in the community. The impact of perinatal transmission has been ificantly mitigated by the strategy of combined passive immunoglobulin and active vaccination immunization [1].

In such situations, there is emerging data that antiviral agents such as telbivudine administered to pregnant women may be efficacious [4], well tolerated [5] as well as cost-effective [6]. Researchers have also tried other antiviral agents including tenofovir [7]; however robust evidence is lacking. Pan, et al. Table I presents the trial outline.

Critical appraisal : The RCT was well deed and conducted as planned. Table II presents a summary of critical appraisal of methodological characteristics using the Cochrane Risk of Bias tool [9]. Overall, the trial had moderate risk-of-bias. The trial included several refinements worthy of mention. Follow-up till 28 weeks postpartum is fairly standard in such trials.

The investigators attempted to measure adherence to therapy by counting pills at follow-up visits although the data are not presented. Follow-up visits were fairly frequent every 4 weeks before delivery and thereafter at 4, 12, 24 and 28 weeks postpartum. The investigators also attempted to monitor development of antiviral resistance by genome sequencing of HBV in case of breakthrough or early discontinuation of treatment.

Various terminologies associated with the trial were strictly defined and objective criteria used where feasible. The authors also conducted several post hoc analyses and presented them in Supplementary tables. Data were analyzed by intention-to-treat, although the principle that all randomized participants should be included in the analysis irrespective of whether or not they receive the intended treatment was not strictly followed. The investigators did not pursue statistical modelling with best-case and worst-case scenarios.

Current data indicate that less than For these reasons, the decision to treat eligible pregnant women with antiviral agents, in our setting has to be individualized rather than empiric [16]. Conclusion: This well-deed multicentric randomized trial suggests that in pregnant women with high probability of transmitting hepatitis B vertically, tenofovir initiated during the third trimester and continued beyond delivery could be a useful intervention to reduce perinatal transmission. : dr. Hepatitis B vaccination with or without hepatitis B immunoglobulin at birth to babies born of HBsAg-positive mothers revents overt HBV transmission but may not prevent occult HBV infection in babies: a randomized controlled trial.

J Viral Hepat. Protective effect of an improved immunization practice of mother-to-infant transmission of hepatitis B virus and risk factors associated with immunoprophylaxis failure. Medicine Baltimore. Nucleos t ide antiviral agents for preventing mother-to-child transmission of hepatitis B virus: an interpretation of relevant international guidelines.

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Telbivudine for prevention of perinatal transmission in pregnant women infected with hepatitis B virus in immune-tolerant phase: a study of efficacy and safety of drug withdrawal. The safety of telbivudine in preventing mother-to-infant transmission of hepatitis B virus in pregnant women after discontinuation. Cost-effectiveness of antiviral therapy during late pregnancy to prevent perinatal transmission of hepatitis B virus. Tenofovir rescue therapy in pregnant females with chronic hepatitis B. World J Gastroenterol. Tenofovir to prevent hepatitis B transmission in mothers with high viral load.

Cochrane Risk of Bias Tool modified for quality assessment of randomize controlled trials. Accessed September 15, Averoff F. Hepatitis B. Puri P. J Clin Exp Hepatol. Seroprevalence of hepatitis B infection during pregnancy and risk of perinatal transmission. Indian J Gastroenterol. Immunological mechanisms of hepatitis B virus persis-tence in newborns. Indian J Med Res ; Evaluation of a programme for prevention of vertical transmission of hepatitis B in a rural block in southern India.

Indian J Med Res. Int Rev Immunol. Kar P, Mishra S. Management of hepatitis B during pregnancy. Expert Opin Pharmacotherap. In their study, Pan, et al. Factors to consider drug therapy for routine use in prevention of mother-to-child transmission include risk of postpartum flares on stopping treatment, drug resistance and lack of long term safety data. Drug resistance is reported to be low with TDF as compared to Lamuvidine, and in this trial all five women with viral rebound showed no genotypic mutation.

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The birth defects rate is 2. Tenofovir was given to women in the third trimester; hence teratogenic potential of the drug cannot be interpreted in the study. One stillbirth and neonatal death was reported in the TDF group as compared to none in the controls but the reasons cited were not linked to TDF.

Limited data is available on maternal side effects like bone remodelling and osteoporosis; maternal creatinine kinase levels were elevated in this study and the result was interpreted as clinically non-ificant. Another area of contention is optimal duration of continuation of therapy postpartum 4 weeks or 12 weeks as the drug is excreted in breast milk and safety data on neonates is insufficient.

In this study, the women were instructed not to breastfeed for 4 weeks in the treatment group. Besides viral load and HBeAg status, other factors responsible for true immunization failure like maternal cytokine polymorphism and transplacental infection are not eliminated with drug therapy. Till date, treatment for hepatitis B infection in pregnant women is given routinely for mothers with advanced disease, acute exacerbation or in liver failure where maternal benefits outweigh fetal risks; its routine use to prevent perinatal transmission is not widely accepted.

The present study indeed adds to the much needed good quality evidence, but larger trials with a longer follow-up in terms of efficacy, duration of treatment and maternal and fetal safety are required for routine practice. Acute hepatitis B virus infection: relation of age to the clinical expression of disease and subsequent development of the carrier state.

Perinatal transmission of hepatitis B virus: an Australian experience. Med J Aust. Interruption of mother-to-child transmission of hepatitis B virus HBV infection is important not only for preventing chronic liver disease and hepatocellular carcinoma in the offspring but also from the perspective of reducing the global burden of chronic liver disease.

Vertical transmission of hepatitis B s for almost half of the chronic liver disease seen worldwide, and India has the second largest pool of chronic HBV infection despite much lower seroprevalence than China and other Southeast Asian countries 0. Combined active and passive immunization is effective in reducing the perinatal transmission of HBV.

However, probability of infant getting infected with HBV despite combined immunization is higher if mother is HBeAg-positive, has high HBV DNA load, is less than 25 years old or infant has not received the required 3 doses of hepatitis vaccine [2]. Overt HBV infection and poor response to hepatitis B vaccine is still common in neonates who receive both hepatitis B immunoglobulin and hepatitis B vaccine [3]. In this scenario, studies have indicated usefulness of nucleotide analogues in enhancing efficacy of combined immunoprophylaxis [4].

The randomized controlled trial by Pan, et al. Tenofovir did not have any ificant adverse effect on mother, fetus or infant. Tenovofir was continued till 4 weeks postpartum and neonates were not breast-fed. However, accumulating evidence from HIV-positive mothers taking tenovofir suggestes that exposure to tenofovir is inificant in a breastfed neonate and there are no ificant adverse effects.

However, based on current recommendations, mother should be counseled about suspending breastfeeding while she is taking tenofovir. With current body of evidence, oral tenofovir prophylaxis must be offered to eligible HBsAg-positive pregnant women. This needs strengthening and standardization of laboratory monitoring and management planning. HBV-DNA levels and HBeAg status must be determined at beginning of third trimester in HBsAg-positive pregnant women, and those classified to have high replicative status should be managed at a tertiary care center by a team of hepatologist, obstetrician and neonatologist.

: drdeepakchawla gmail. Immunological mechanisms of hepatitis B virus persistence in newborns. Outcomes of infants born to women infected with hepatitis B. Hepatitis B vaccination with or without hepatitis B immunoglobulin at birth to babies born of HBsAg-positive mothers prevents overt HBV transmission but may not prevent occult HBV infection in babies: a randomized controlled trial.

Antiviral therapy in chronic hepatitis B viral infection during pregnancy: A systematic review and meta-analysis. Hepatol Baltim Med. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a update. Hepatol Int. Commentaries Evidence-based Medicine Viewpoint Relevance : Perinatal transmission of Hepatitis B infection is associated with unpleasant consequences for individuals as well as the society — the former because transmission from mothers with active viral replication is associated with high probability of chronicity in the affected offspring, and the latter because it contributes to the pool of chronic carriers in the community.

Table I Outline of the Trial. Indian Pediatr ; Section Editor : Abhijeet Saha. Table I Outline of the Trial Study de. Randomized controlled trial. Study setting. Five academic institutions located in five geographic regions in China. Study duration. Sample size. The calculated sample size of was achieved. Inclusion criteria. Exclusion criteria.

Intervention and Comparison groups. Intervention Tenofovir group : Oral tenofovir mg daily from weeks gestation until 4 weeks postpartum. Comparison Usual care group : No placebo was used. Primary outcomes:. Secondary outcomes:. Statistical analysis. Data were analyzed by intention-to-treat ITT wherein all enrolled participants who received the ased treatment were included in analysis.

Per protocol analysis was also done. Investigators undertook appropriate statistical tests. Main tenofovir vs no tenofovir. Primary outcomes. Secondary outcomes.

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Similarity of groups at baseline. Infant gestation, mode of delivery, anthropometric measurements, and 1 minute Apgar score, were also comparable. Sequence generation. A random table was used and participants were randomized in blocks. No other details are available.

Allocation concealment. There was no allocation concealment procedure. This was an open label trial where neither the participants, not outcome assessors were blinded. Incomplete outcome data. Selective outcome reporting. Almost all possible outcomes relevant to the PICO question have been presented. Other sources of bias.

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