Source: Abstract #PS-098 Ledipasvir/sofosbuvir for 12 weeks is safe and effective in patients with chronic hepatitis C and hepatitis B coinfection: A phase 3 study in Taiwan C—J. Liu, et al.
Study Aims and Results: Compared to people who have either hepatitis B or C, patients who are coinfected with both have more rapid liver disease. This study evaluated the safety and efficacy of treatment using ledipasvir (LDV)/sofosbuvir (SOF) for 12 weeks in patients with chronic HCV and HBV coinfection in Taiwan, which has a high prevalence of HCV/HBV coinfection. The main goal was to measure SVR12 while monitoring HBV DNA during treatment and for 2 years post-treatment. At the time of this presentation, SVR4 rate was 100% based on 111 patients. Although most patients experienced an increase in HBV DNA during treatment, this was not associated with ALT elevations ≥2 × baseline, and no patients started HBV therapy to date.
Conclusions: LDV/SOF was well tolerated, and is a potential treatment option for HCV/HBV coinfected patients.
Editorial Comments: Hepatitis C direct-acting antivirals (DAAs) carry a black box warning, stating that there is a risk of hepatitis B virus reactivation in patients coinfected with hepatitis C and B virus. The FDA reported at least 24 cases of hepatitis B reactivation from 2013-2016. Of these, two patients died; one required a liver transplant. The FDA believes that there may be additional unreported cases of hepatitis B reactivation that occurred with DAA treatment for hepatitis C.
This study is entirely too small and too preliminary to draw conclusions about the safety of HCV treatment using DAAs in coinfected patients, albeit it is a good study. If you are coinfected, be sure your medical provider tests for current or prior hep B infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc), prior to starting hepatitis C treatment with the commonly used DAAs, Click here to read the entire FDA Hepatitis Update.
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