Article ; Online: Clinical trials in hepatitis D virus: Measuring success.
2022 Volume 77, Issue 6, Page(s) 2147–2157
Abstract: Chronic hepatitis D infection results in the most severe form of chronic viral hepatitis but currently lacks effective treatment options. Therapy with pegylated interferon alpha is recommended for finite treatment duration by major liver societies. Still, ...
Abstract | Chronic hepatitis D infection results in the most severe form of chronic viral hepatitis but currently lacks effective treatment options. Therapy with pegylated interferon alpha is recommended for finite treatment duration by major liver societies. Still, it is plagued by low rates of sustained virologic response (SVR) and frequent relapses even if SVR is achieved. Recently, a wave of investigational therapies has come under evaluation, including bulevirtide, lonafarnib, pegylated interferon lambda, and REP-2139 creating excitement with this viral infection. However, there has been significant variability in the endpoints used to evaluate these therapeutics. One of the recently introduced endpoints is characterized by a decline in HDV RNA by 2 logs, with or without achieving an undetectable serum hepatitis D virus (HDV) RNA, as a marker of virologic response. Furthermore, this measure has been combined with alanine aminotransferase normalization, also known as a biochemical response, to formulate the primary endpoint of several late-stage studies. Per recent guidance by the US Food and Drug Administration, these should be surrogate endpoints that will ultimately portend long-term clinical benefits. These clinical benefits may include reducing the risk of progression to cirrhosis, hepatic decompensation, hepatocellular carcinoma, liver transplantation, and mortality. However, the optimal way to measure success in HDV clinical trials remains unknown and will continue to evolve. |
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MeSH term(s) | Humans ; Hepatitis Delta Virus ; Antiviral Agents ; Neoplasm Recurrence, Local ; Hepatitis D ; Hepatitis D, Chronic/drug therapy ; Polyethylene Glycols/therapeutic use ; RNA |
Chemical Substances | Antiviral Agents ; Polyethylene Glycols (3WJQ0SDW1A) ; RNA (63231-63-0) |
Language | English |
Publishing date | 2022-10-22 |
Publishing country | United States |
Document type | Journal Article |
ZDB-ID | 604603-4 |
ISSN | 1527-3350 ; 0270-9139 |
ISSN (online) | 1527-3350 |
ISSN | 0270-9139 |
DOI | 10.1002/hep.32732 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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