Last updated on August 2019

Tenofovir Alafenamide in Preventing Liver Complications in Participants With Current or Past Hepatitis B Virus Who Are Receiving Anti-Cancer Therapy for Solid Tumors


Brief description of study

This phase III trial studies how well tenofovir alafenamide works in preventing liver complications in participants with current or past hepatitis B virus (HBV) who are receiving anti-cancer therapy for solid tumors. People with chronic or past HBV who are undergoing therapy for cancer are at an increased risk for changes in the liver which could be minor or severe. Tenofovir alafenamide is a drug that acts against infections caused by HBV and may help reduce the chance that HBV gets worse or comes back in participants receiving anti-cancer therapy for solid tumors.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare the effect of prophylactic tenofovir alafenamide (TAF) therapy versus upon indication TAF therapy on time-to-adverse liver outcomes of liver failure or liver-related death in patients with chronic HBV infection (hepatitis B surface antigen positive [HBsAg+] and antibody to hepatitis B core antigen positive [anti-HBc+]) receiving anti-cancer therapy for solid tumors.

II. To compare the effect of upon indication TAF therapy versus usual care on time-to-adverse liver outcomes of liver failure or liver-related death in patients with past HBV infection (hepatitis B surface antigen negative [HBsAg-] and anti-HBc+) receiving anti-cancer therapy for solid tumors.

SECONDARY OBJECTIVES:

I. Using time-to-event analysis, to compare the effect of TAF therapy versus upon indication TAF therapy on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with chronic HBV infection receiving anti-cancer therapy for solid tumors.

II. Using time-to-event analysis, to compare the effect of upon indication TAF therapy versus usual care on HBV reactivation, on the combined endpoint of adverse liver outcomes (liver failure or liver-related death) and HBV reactivation, and on HBV flare by arm in patients with past HBV infection receiving anti-cancer therapy for solid tumors.

TRANSLATIONAL OBJECTIVES:

I. To compare baseline and changes in overall immune status and HBV-specific immune response in patients with solid tumors and chronic or past HBV infection receiving anti-cancer therapy, and to compare the differences in these immune responses by HBV reactivation status.

II. To identify demographic and clinical predictors and correlative immunologic biomarkers of HBV reactivation after receipt of anti-cancer therapy in patients with solid tumors and chronic or past HBV infection.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP A (Cohorts 1a & 2a): Participants receive TAF orally (PO) once daily (QD) immediately or within 28 days after initial dose of chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

GROUP B (Cohorts 1b & 2b): Participants receive TAF PO QD after HBV reactivation during chemotherapy. Treatment continues for up to 6 months after the last dose of chemotherapy or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

GROUP C (Cohort 3): Participants receive TAF PO QD at the discretion of the physician during usual care. Treatment continues for up to 6 months after discontinuation of usual care or a maximum of 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up for up to 24 months.

Clinical Study Identifier: NCT03887702

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Heartland Regional Medical Center

Saint Joseph, MO United States
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