GSK China announced approval of Viread’s updated safety statistics for treatment of chronic hepatitis B in pregnant patients
12 March 2019
Recently, GSK China announced that its specification of Viread (tenofovir disoproxil fumarate), an oral antiviral drug for chronic hepatitis B treatment, has received approval by the National Medical Products Administration1 for its updated safety statistics on chronic hepatitis B treatment in pregnant patients. The statistics show that Viread has a positive impact on safeguarding the treatment of chronic hepatitis B in pregnant. Thanks to its effectiveness, zero resistance as of now, and liver cirrhosis reversal, Viread has been recommended as the first-line chronic hepatitis B therapy drug according to guidelines at home and abroad. Meanwhile, based on a number of real-world research data, Viread has been verified for its safety in pregnant patients and has been recommended for the first-line treatment of chronic hepatitis B in pregnant patients according to international guidelines.
Data released in 2017 by World Health Organization shows that more than 90 million persons are chronically infected with hepatitis B virus in China2. Statistics show that in 2010 there were about 380 million women of childbearing age in China3, and the HBsAg positive rate of this group was around 6.0%4. Estimates show there were around 22.80 million women of childbearing age that were chronically infected with HBV, which include a large number of chronic hepatitis B patients that need treatment. As such, a safe and effective therapy for pregnant chronic hepatitis B patients will contribute significantly to the further reduction of viral hepatitis transmission. In addition, with the liberalization of the family planning policy in China, the general public has an increasing awareness on drug safety for pregnant women and newborns. The government has also recently launched a series of regulations and guidelines on drug safety, including “Strengthening Clinical Medication Management in Pregnant Women and Children”, in order to increase the drug safety.
Dr. James He, Vice President, Head of R&D and Medical in GSK China, commented, “Pregnant chronic hepatitis B patients are a special group in that they are entitled to particularly high standards for the safety of drug use. The approval of Viread’s updated safety statistics is important to ensure higher safety of drug use for pregnant hepatitis B patients.”
The pregnancy exposure registry monitored pregnancy outcomes in women exposed to tenofovir disoproxil fumarate (TDF) during pregnancy, and the results were evaluated based on prospective reports from the Antiretroviral Pregnancy Registry (APR). It shows
that in the 3,342 exposed cases in the first trimester and the 1,475 exposed cases in the second/third trimester, there was no increase in overall major birth defects (2.3%, 2.1%) with TDF compared with the background birth defect rate of 2.7% in a U.S. reference population of the MACDP. In addition, a large number of data (more than 1000 pregnancy outcomes in women) shows that no malformation or fetal / neonatal toxicity has been found related to TDF exposure.
Viread has currently been approved in more than 100 countries and regions for chronic hepatitis B treatment. Since its launch in China in 2014, it has played a critical role in controlling chronic hepatitis B transmission in China and meeting unmet treatment needs providing effective support for more patients.
“GSK has remained devoted to supporting chronic hepatitis B prevention and treatment in China by delivering safe and effective medicines, actively engaging in R&D, and participating in physician training and education in grass-roots hospitals,” Dr. James He added. “Guided by its patient-focusing values, GSK will strive to provide more care and create more benefit for all the patient groups suffering from chronic hepatitis B.”
1 Official website of National Medical Products Administration: http://samr.cfda.gov.cn/WS01/CL0135/;please check on comprehensive matters ofadministrative licensesvia the website.
2 Source: World Health Organization“Global HepatitisReport 2017”, Page 42;https://www.who.int/hiv/pub/hepatitis/global-hepatitis-report2017-executive-summary/zh/;please check on the full report via the website.
3 Qin Zhu, The Estimation of Fertility Level in China from 2000 to 2010 based on the Initial Research on the 6th Population Census of the People’s Republic of China[J], Chinese Journal of Population Science 2012(4):68-77
4 Xin X, Wang Y, Cheng J, et al. [J]. Journal of Clinical Virology, 2016, 81:47-52.