Drug Therapy Okay for Pregnant Women With HBV

AASLD: Drug Therapy Okay for Pregnant Women With Hep B
By Kristina Fiore, Staff Writer, MedPage TodayPublished: October 31, 2010Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco.

BOSTON -- Pregnant women with active hepatitis B infection can be safely and effectively treated with telbivudine (Tyzeka), researchers said here.

A study involving more than 80 women found that just over half of the women given telbivudine achieved a complete virologic response right before delivery compared with none of the controls (P<0.001), according to Calvin Pan, MD, of Mount Sinai School of Medicine in Flushing, N.Y., and colleagues.

Additionally, a smaller proportion of babies born to women in the telbivudine group had surface antigens for hepatitis B virus compared with controls (4% versus 23%, P<0.001), the researchers reported at the annual meeting of the American Association for the Study of Liver Diseases (AASLD).

"I think this treatment is safe, and I support its use if the mother has active virus," Pan told MedPage Today.

There has been a controversy over whether pregnant women with hepatitis B should be treated, mainly due to concerns over the safety of the fetus.

Pan said this is the first randomized controlled trial to investigate drug safety and efficacy in pregnant women with active hepatitis B infection. Other case series have examined the question -- but no studies have been randomized and controlled.

To evaluate both virologic responses and safety parameters, Pan and colleagues assessed 88 pregnant women with active hepatitis B from their second or third trimester until four weeks postpartum.

A total of 53 women received 600 mg of telbivudine per day, while 35 women who refused drug treatment agreed to serve as controls.

All babies born to women in the study cohort also received 200 IU of hepatitis B immune globulin within 24 hours of birth to prevent the disease -- and were then vaccinated against the virus with the standard three-dose course at 0, 1, and 6 months.

The mean duration of treatment in the telbivudine group was 15 weeks and 100% were followed through the end of study, compared with 92% of the controls.

The researchers found that 53% of the telbivudine-treated women achieved complete virologic response prior to delivery, compared with none among the control group (P<0.001).

Four weeks after giving birth, 62% of the treated patients had a complete virologic response versus none of the controls (P<0.001).

As well, more women on treatment also had normalized alanine aminotransferase (ALT) levels compared with controls (77% versus 29%, P<0.001).

Both groups appeared to have decreased levels of hepatitis B "e" antigen -- but the drop was higher for those women treated with telbivudine (98% versus 60%, P<0.001).

Pan explained that pregnant women with active hepatitis B can have natural clearance of the virus without treatment, but noted that the decrease in the treatment arm "was still significantly higher."

In terms of fetal outcomes, more babies born to mothers who weren't on treatment had hepatitis B surface antigens compared with those on treatment (23% versus 4%, P<0.001).

Pan added that newborn outcomes were examined in greater detail in a second study, which found that at birth 6.32% of babies born to telbivudine-treated women had surface antigen to the hepatitis B virus -- compared with 30.43% in the control arm (P<0.001).

There were no discontinuations of telbivudine treatment due to adverse events -- nor were there any congenital deformities four weeks postpartum in either group.

Also, there were no differences in terms of postpartum hemorrhage, gestational age, infant height and weight, or Apgar scores.

Arun Sanyal, MD, of Virginia Commonwealth University in Richmond, Va., and president of AASLD, highlighted the findings during a press conference.

"Now we have more evidence," Sanyal said, "showing that it is possible with pharmacotherapy to reduce perinatal transmission and treat these women safely."

Pan said he had no disclosures.

Sanyal reported relationships with Takeda, Salix, Ikaria, Astellas, Exhalenz, Bayer Onyx, Norgine, Gore, Gilead, Intercept, and Roche.


Primary source: American Association for the Study of Liver Diseases
Source reference:
Pan C, et al "A prospective open-label study to evaluate the efficacy, safety, and tolerability of telbivudine in HBeAg + chronic hepatitis B pregnant women" AASLD 2010; Abstract 364.
http://www.medpagetoday.com/MeetingCoverage/AASLD/23068