Antiviral Agent HARVONI® for the Treatment of HCV-associated Indolent B-Cell Lymphoma
Status:
Unknown status
Trial end date:
2021-08-15
Target enrollment:
Participant gender:
Summary
We and other investigators have revealed an association between Hepatitis C virus (HCV)
seropositivity and an increased risk of developing marginal zone B-cell lymphoma (MZ),
lymphoplasmacytic lymphoma (LPL, also known as Waldenström's macroglobulinemia), follicular
lymphoma (FL), and diffuse large B-cell lymphoma (DLBCL). The sustained virologic response
(SVR) to treatment with interferon or pegylated (Peg)IFN with ribavirin was closely
associated with the regression of HCV-associated B-cell NHL (mainly MZL, and LPL).
Currently, the second-generation direct-acting antiviral agents (DAAs), such as sofosbuvir,
have been shown to have a higher cure rate, less side effects, and a shorter duration of
therapy for chronic HCV infection. After the approval of DAA for HCV therapy, several recent
anecdotal case reports showed that indolent low-grade B-cell NHLs regressed after HCV
clearance by DAAs. It is noted that the time to complete remission of these lymphomas was
around 20 to 24 weeks after starting DAAs. These findings indicate that DAAs can eradicate
the trigger of lymphomagenesis by curing chronic HCV infection.
Because DAAs are more potent and efficient than pegylated (Peg) interferon plus ribavirin and
well-tolerated for the treatment of HCV infection, it is reasonable to use DAAs as the
frontline treatment for HCV-positive patients with indolent B-cell NHL, such as MZL, LPL, and
low-grade FL, who do not require immediate cytoreductive therapy. The aim of this proposal is
to assess whether Harvoni® (ledipasvir and sofosbuvir) could eradicate HCV and lead to
durable complete remission of these lymphomas..
Phase:
Phase 2
Details
Lead Sponsor:
National Taiwan University Hospital
Treatments:
Antiviral Agents Ledipasvir Ledipasvir, sofosbuvir drug combination Sofosbuvir