Biotest AG: Hepatect(R) CP and Zutectra(R) show marked efficacy in the prevention of HBV reinfection after liver transplantation in long-term study
News: Biotest AG / Key word(s): Research Update
Hepatect(R) CP and Zutectra(R) show marked efficacy in the prevention of HBV reinfection after liver transplantation in long-term study
- 371 liver transplanted patients observed over almost seven years
- No hepatitis B virus reinfection was observed in patients receiving Zutectra(R)
- Results support the long-term use of Hepatect(R) CP / Zutectra(R)
- Biotest plans to enter further markets
Dreieich, 20 November 2018. Biotest reports positive results from a long-term data collection of Hepatect(R) CP and Zutectra(R) use after liver transplantation. The study involved 371 patients from 20 transplant centres across Germany, Italy, the United Kingdom, the Netherlands and Switzerland. Patients were observed over an average of 6.8 years.
Overall, the number of reinfections with the hepatitis B virus was only 0.65 percent per year; only 16 of the 371 study participants were reinfected during the observation period. No HBV reinfection occurred in the 236 patients treated with Zutectra(R), with one exception, which resulted from underdose.
The data collection comprised many patients with a pronounced high risk of HBV reinfection. For example, 147 patients underwent liver transplantation due to HBV-associated liver cell carcinoma (HCC). HCC, a virulent (malignant) cancer that develops directly from liver cells, is one of the leading causes of cancer-related deaths worldwide. These patients may benefit additionally from treatment with Hepatect(R) CP and Zutectra(R): The study showed an annual average recurrent HCC rate of only 1.7 percent.
The data from the long-term study clearly demonstrate the benefit of a lifelong therapy with Hepatect(R) CP and Zutectra(R). The data also supports the 2017 updated clinical practice guidelines of EASL (European Association for the Study of the Liver). According to these guidelines, combination therapy with immunoglobulins such as Hepatect(R) CP and Zutectra(R) and an antiviral drug is an effective strategy to prevent HBV reinfection in high-risk liver transplant recipients.
Biotest has become one of the market leaders as an expert in plasma proteins and hepatitis B immunoglobulins. With Zutectra(R), Biotest is the first and only provider worldwide of a subcutaneous administration form, i.e. a product that patients can administer themselves at home. In order to meet the high medical needs worldwide, Biotest plans to enter new and attractive markets in the future.
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