This news release describes a clinical trial testing whether an antiviral drug given to pregnant women in their third trimester reduces their hepatitis B viral load. The study also examined whether the drug limits the transmission of the virus from mother to baby. The answers to both questions are yes, suggesting a new strategy for dealing with the spread of this disease.
The release does a good job describing harms, quantifying benefits and describing the study protocol. Because the cost of hepatitis drugs has been widely debated for the past few years, a mention of the drug’s cost would have made the release stronger.
Almost 240 million people are infected with hepatitis B virus and about 780,000 die each year from the disease, according to the World Health Organization. The hepatitis B virus infects the liver and while many recover with treatment, it can become a chronic infection. Babies and young children infected with the virus are more likely to develop chronic hepatitis B. If administering a drug to infected mothers reduces the proportion of newborns getting the disease, it would be a considerable improvement in public health.
The release makes no mention of the cost of the drug in question, Tenofovir. A web search found that the cost for a month’s supply of the antiviral drug averages just over $1,000. For some patients, that cost may be prohibitive. The cost is an issue of particular concern for developing countries, but it is also true that the price may be much lower for them than in the United States. Many pharmaceutical companies offer their drugs at steeply discounted rates in poorer countries to expand access to life-saving medicines.
The release clearly says that 68 percent of women receiving the drug reduced their viral load while only 2 percent of the women in the control group had that success. It also says that the transmission of hepatitis B from mother to newborn dropped from 18 percent to 5 percent, an important clinical outcome.
The release includes a discussion of harms. It states that “tenofovir was well tolerated; only one participant treated with tenofovir voluntarily withdrew from the study due to nausea.” It also says that researchers “found no significant differences between the tenofovir-treated group and the control group with regard to fetal development and infant growth.” Lastly, it calls for longer term, observational studies to confirm the safety of fetal exposure to tenofovir treatment.
The release provides a good overview of the randomized, placebo-controlled trial which was undertaken to gauge the efficacy of the drug in both reducing the viral load of hepatitis-B-positive mothers and reducing the rate of transmission of the disease from mother to newborn. It offers solid, numerical evidence of both outcomes. It describes the number of patients (200 pregnant women), defined what constituted a “high” viral load, and described the approximate length of treatment. It did omit a mention of whether the trial was blinded.
This release does not commit disease mongering.
The release notes that the research is funded by Gilead Sciences. It should also have mentioned that a corresponding author disclosed speaking and advising fees from Gilead, according to the published study.
The release is comparing the use of an antiviral drug given to pregnant women versus the normal procedure of giving both a vaccine and immune globulin.
The release doesn’t mention that tenofovir (marketed as Viread), the drug being tested, is already an FDA approved drug so many readers may not know that it’s available. It was approved by the FDA in 2001 for HIV and in 2008 for chronic hepatitis B.
The release just barely implies novelty with this statement which suggests a change in treating infected women who are pregnant:
“Based on the findings, the investigators recommend that women be tested for HBV viral load at week 28 of pregnancy. Those with a high viral load should receive tenofovir treatment starting at gestational week 30 until delivery to reduce the risk of transmission to their infants.”
While the drug itself isn’t novel, positive outcomes from a controlled trial on pregnant women carrying the virus does seem to introduce a new treatment approach.
This release does not use any unjustifiable language.