In the Journals

Tenofovir safe, effective in mother-to-child HBV transmission prevention

Data from a recently published meta-analysis showed that administrating tenofovir in the second or third trimester of pregnant women with hepatitis B and high HBV DNA levels was safe and tolerable for both mother and child, and can prevent viral transmission when combined with HBV immunoglobulin and vaccine.

“Majority of worldwide guidelines recommend tenofovir as the preferred choice for [mother-to-child transmission] prevention in terms of anti-viral potency, available safety data during pregnancy and concerns for resistance compared to other anti-viral agents. To date, a small number of case series and relatively well-designed non-randomized controlled trails ... using tenofovir have been conducted,” the researchers wrote. “However, since there is only one [randomized control trial] currently available, there are still concerns whether [one] provides sufficient evidence to disregard all the other [non-randomized control trials].”

The researchers reviewed the PubMed, EMBASE and Cochrane databases from inception to Aug. 16, 2016, for cases that included data on tenofovir use in pregnant women with HBV during the second or third trimester and control comparisons. The meta-analysis included 10 studies — one randomized control trial, four non-randomized control trials and five case studies — with a total of 733 patients. The randomized and non-randomized control trials had comparable data.

Mean patient age was 29.7 years, all were HBeAg-positive except for one trial, and all patients had a high maternal HBV DNA level of over 2 x 105 IU/mL.

One randomized trial and two non-randomized trials reported significant HBV DNA suppression in patients undergoing treatment with tenofovir (OR = 260.41; 95% CI, 29.92-2,266.17), though the definition of HBV DNA suppression differed between the studies. Alanine aminotransferase normalization rates from one non-randomized trial (OR = 2.55; 95% CI, 0.65-10.01) were comparable with HBeAg seroconversion rates in one randomized and one non-randomized trial (OR = 1.28; 95% CI, 0.07-24.11) between tenofovir patients and control groups.

In one randomized and one non-randomized trial, newborn HBsAg seropositivity rates were an average of 8% in the tenofovir group and an average of 9% in the control group (OR = 0.87; 95% CI, 0.31-2.4). In the same comparison of trials, HBV DNA was an average of 4.3% in the tenofovir group and 20.5% in the control group, demonstrating a reduced risk for newborn HBV DNA positivity by 84% with tenofovir (OR = 0.16; 95% CI, 0.07-0.39).

The trial studies reported HBsAg seropositivity of infants within 6 to 12 months. HBsAg seropositivity was an average of 2.9% in the tenofovir group and 11% in the control group, demonstrating a reduced risk for HBsAg seropositivity by 77% with tenofovir (OR = 0.23; 95% CI, 0.1-0.52).

Among comparable trial studies, tenofovir treatment had similar creatine kinase elevation rates (OR = 8.49; 95% CI, 0.98-73.28), creatinine elevation rates (OR = 0.34; 95% CI, 0.01-8.45), ALT flares (OR = 1; 95% CI, 0.31-3.24), cesarean section rates (OR = 1.27; 95% CI, 0.85-1.87) and post-partum hemorrhage rates (OR = 0.76; 95% CI, 0.27-2.16) compared with the control groups.

Tenofovir groups and control groups also had no significant differences between congenital malformations (OR = 1.6; 95% CI, 0.3-8.47), pre-term birth rates (OR = 2.39; 95% CI, 0.84-6.81), low birthweights of less than 2,500 g (OR = 1.1; 95% CI, 0.06-18.77) or fetal deaths (OR = 1.28; 95% CI, 0.2-8.25).

“Tenofovir therapy in HBV infected mothers in the second or third trimester efficiently interrupts [mother-to-child transmission], as indicated by infant serum HBsAg positivity,” the researchers concluded. “Tenofovir treatment is safe and tolerable for both the mother and fetus. Clinicians who manage pregnant patients with high hepatitis B viral loads should consider tenofovir therapy to prevent [viral transmission] in addition to immunoprophylaxis combination therapy.” – by Talitha Bennett

Disclosures: The researchers report no relevant financial disclosures.

Data from a recently published meta-analysis showed that administrating tenofovir in the second or third trimester of pregnant women with hepatitis B and high HBV DNA levels was safe and tolerable for both mother and child, and can prevent viral transmission when combined with HBV immunoglobulin and vaccine.

“Majority of worldwide guidelines recommend tenofovir as the preferred choice for [mother-to-child transmission] prevention in terms of anti-viral potency, available safety data during pregnancy and concerns for resistance compared to other anti-viral agents. To date, a small number of case series and relatively well-designed non-randomized controlled trails ... using tenofovir have been conducted,” the researchers wrote. “However, since there is only one [randomized control trial] currently available, there are still concerns whether [one] provides sufficient evidence to disregard all the other [non-randomized control trials].”

The researchers reviewed the PubMed, EMBASE and Cochrane databases from inception to Aug. 16, 2016, for cases that included data on tenofovir use in pregnant women with HBV during the second or third trimester and control comparisons. The meta-analysis included 10 studies — one randomized control trial, four non-randomized control trials and five case studies — with a total of 733 patients. The randomized and non-randomized control trials had comparable data.

Mean patient age was 29.7 years, all were HBeAg-positive except for one trial, and all patients had a high maternal HBV DNA level of over 2 x 105 IU/mL.

One randomized trial and two non-randomized trials reported significant HBV DNA suppression in patients undergoing treatment with tenofovir (OR = 260.41; 95% CI, 29.92-2,266.17), though the definition of HBV DNA suppression differed between the studies. Alanine aminotransferase normalization rates from one non-randomized trial (OR = 2.55; 95% CI, 0.65-10.01) were comparable with HBeAg seroconversion rates in one randomized and one non-randomized trial (OR = 1.28; 95% CI, 0.07-24.11) between tenofovir patients and control groups.

In one randomized and one non-randomized trial, newborn HBsAg seropositivity rates were an average of 8% in the tenofovir group and an average of 9% in the control group (OR = 0.87; 95% CI, 0.31-2.4). In the same comparison of trials, HBV DNA was an average of 4.3% in the tenofovir group and 20.5% in the control group, demonstrating a reduced risk for newborn HBV DNA positivity by 84% with tenofovir (OR = 0.16; 95% CI, 0.07-0.39).

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The trial studies reported HBsAg seropositivity of infants within 6 to 12 months. HBsAg seropositivity was an average of 2.9% in the tenofovir group and 11% in the control group, demonstrating a reduced risk for HBsAg seropositivity by 77% with tenofovir (OR = 0.23; 95% CI, 0.1-0.52).

Among comparable trial studies, tenofovir treatment had similar creatine kinase elevation rates (OR = 8.49; 95% CI, 0.98-73.28), creatinine elevation rates (OR = 0.34; 95% CI, 0.01-8.45), ALT flares (OR = 1; 95% CI, 0.31-3.24), cesarean section rates (OR = 1.27; 95% CI, 0.85-1.87) and post-partum hemorrhage rates (OR = 0.76; 95% CI, 0.27-2.16) compared with the control groups.

Tenofovir groups and control groups also had no significant differences between congenital malformations (OR = 1.6; 95% CI, 0.3-8.47), pre-term birth rates (OR = 2.39; 95% CI, 0.84-6.81), low birthweights of less than 2,500 g (OR = 1.1; 95% CI, 0.06-18.77) or fetal deaths (OR = 1.28; 95% CI, 0.2-8.25).

“Tenofovir therapy in HBV infected mothers in the second or third trimester efficiently interrupts [mother-to-child transmission], as indicated by infant serum HBsAg positivity,” the researchers concluded. “Tenofovir treatment is safe and tolerable for both the mother and fetus. Clinicians who manage pregnant patients with high hepatitis B viral loads should consider tenofovir therapy to prevent [viral transmission] in addition to immunoprophylaxis combination therapy.” – by Talitha Bennett

Disclosures: The researchers report no relevant financial disclosures.