News & Events

Published On: 7/1/2021

Target RWE HBV Research on Antiviral Treatments, Characteristics, and Clinical Outcomes Published in Digestive Diseases and Sciences

The hepatitis B virus (HBV) is a vaccine-preventable liver infection that can spread through contact with a person infected with the virus by sharing needles, having unprotected sex, being exposed to their blood, or from maternal-to-child transmission in endemic areas of the world.¹ Chronic HBV is managed by balancing the benefits of long-term suppression of the virus with the potential serious side effects associated with prolonged, often lifelong, antiviral therapy. Oral antiviral therapies including entecavir and tenofovir disoproxil fumarate (TDF) have been available in the U.S. since 2005 and 2008, respectively, for the treatment of chronic HBV. A newer treatment option approved in 2016, tenofovir alafenamide (TAF) that is also known as the brand Vemlidy, is an FDA-approved antiviral prescription medicine for the treatment of HBV in adults that has demonstrated a reduction in kidney and bone side effects compared to TDF.^2,3 

The latest Target RWE analysis of patients enrolled in the active TARGET-HBV (NCT03692897) longitudinal study was recently published in Digestive Diseases and Sciences (https://doi.org/10.1007/s10620-021-07033-y). The Target RWE study analysis, Safety and Effectiveness of Tenofovir Alafenamide in Usual Clinical Practice: TARGET-HBV, gathered retrospective real-world data from electronic health records of 500 patients enrolled in TARGET-HBV and examined the characteristics and clinical outcomes of those patients treated with TAF in usual clinical practice. The TARGET-HBV research found:

• Most patients (82%) treated with TAF had been switched from other antiviral medications
• TAF’s perceived safety profile was cited as the primary reason for changing therapy to TAF (32%); and
• Only 4 patients discontinued TAF therapy due to an adverse event during a median duration of 74 weeks, ultimately supporting the growing body of evidence related to the safety and effectiveness of TAF.

Launched in 2018, Target RWE sponsors and actively generates valuable real-world data of patients diagnosed with chronic hepatitis B through its observational, longitudinal study- TARGET-HBV. TARGET-HBV conducts a comprehensive review of therapeutic outcomes for people living with HBV who are currently taking TAF relative to those patients following other treatment approaches. The ongoing, prospective collection of data from patients at academic and community medical centers will address important clinical questions regarding the current and future management of chronic hepatitis B.

Contact Target RWE today to learn more about TARGET-HBV!

 

¹ https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#overview
² Chan HL, Fung S, Seto WK, Chuang WL, Chen CY, Kim HJ, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg-positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1(3):185-95.
³ Buti M, Gane E, Seto WK, Chan HL, Chuang WL, Stepanova T, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet Gastroenterol Hepatol. 2016;1(3):196-206.