Trial Outcomes & Findings for Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors (NCT NCT03887702)
NCT ID: NCT03887702
Last Updated: 2024-05-20
Results Overview
Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
4 participants
Primary outcome timeframe
From randomization to 24 months
Results posted on
2024-05-20
Participant Flow
Participant milestones
| Measure |
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 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.
Entecavir: Given PO
Tenofovir Alafenamide: Given PO
Tenofovir Disoproxil Fumarate: Given PO
|
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
Entecavir: Given PO
Tenofovir Alafenamide: Given PO
Tenofovir Disoproxil Fumarate: Given PO
|
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
Entecavir: Given PO
Tenofovir Alafenamide: Given PO
Tenofovir Disoproxil Fumarate: Given PO
|
Arm 4 (Anti-Viral Therapy: Usual Care)
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
2
|
2
|
|
Overall Study
Received Anti-HBV Treatment Per Assignment
|
0
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir PO QD immediately or within 42 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.
Entecavir: Given PO
Tenofovir Alafenamide: Given PO
Tenofovir Disoproxil Fumarate: Given PO
|
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
Entecavir: Given PO
Tenofovir Alafenamide: Given PO
Tenofovir Disoproxil Fumarate: Given PO
|
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
Entecavir: Given PO
Tenofovir Alafenamide: Given PO
Tenofovir Disoproxil Fumarate: Given PO
|
Arm 4 (Anti-Viral Therapy: Usual Care)
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for HBV may be used.
|
|---|---|---|---|---|
|
Overall Study
Study terminated
|
0
|
0
|
2
|
2
|
Baseline Characteristics
Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therapy for Solid Tumors
Baseline characteristics by cohort
| Measure |
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
\[Cohort 1\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 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.
|
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
n=2 Participants
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 4 (Anti-Viral Therapy: Usual Care)
n=2 Participants
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
—
|
47.5 years
n=5 Participants
|
75.4 years
n=4 Participants
|
62.45 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From randomization to 24 monthsPopulation: There were no participants registered to the Chronic HBV infection cohort \[Cohort 1, Arms 1 and 2\]
Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review.
Outcome measures
| Measure |
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
\[Cohort 1\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 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.
|
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
n=2 Participants
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 4 (Anti-Viral Therapy: Usual Care)
n=2 Participants
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Liver Outcome
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization up to 24 monthsPopulation: There were no participants registered to the Chronic HBV infection cohort \[Cohort 1, Arms 1 and 2\]
HBV reactivation is is defined as one of the following: * ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or * HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or * HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or * HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-.
Outcome measures
| Measure |
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
\[Cohort 1\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 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.
|
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
n=2 Participants
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 4 (Anti-Viral Therapy: Usual Care)
n=2 Participants
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.
|
|---|---|---|---|---|
|
Number of Participants With Hepatitis B Virus (HBV) Reactivation
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to 24 monthsPopulation: There were no participants registered to the Chronic HBV infection cohort \[Cohort 1, Arms 1 and 2\]
Hepatitis flare is defined as ALT \> 3 x baseline and \>100 U/L.
Outcome measures
| Measure |
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
\[Cohort 1\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 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.
|
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
n=2 Participants
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 4 (Anti-Viral Therapy: Usual Care)
n=2 Participants
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.
|
|---|---|---|---|---|
|
Number of Participants With Hepatitis B Virus (HBV) Flare
|
—
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From randomization to 24 monthsPopulation: There were no participants registered to the Chronic HBV infection cohort \[Cohort 1, Arms 1 and 2\]
Adverse liver outcome: Defined as liver-related death or liver failure (ascites, hepatic encephalopathy or impaired hepatic synthetic function defined as total bilirubin ≥ 5 mg/dL or INR ≥ 2.0) not due to disease progression in the liver. Assessment of the primary endpoint will be made by sites and subsequently adjudicated by the research oversight team by blinded review. HBV reactivation is defined as one of the following: * ≥ 2 log (100-fold) increase in HBV DNA compared to baseline in patients with detectable HBV DNA at baseline, or * HBV DNA ≥ 3 log (1,000) IU/mL in a patient with previously undetectable HBV DNA, or * HBV DNA ≥ 4 log (10,000) IU/mL if baseline HBV DNA not available, or * HBsAg seroreversion (HBsAg- to HBsAg+) in a patient previously HBsAg-. The combined endpoint of adverse liver outcomes and HBV reactivation is the occurrence of either adverse liver outcome or HBV reactivation as defined above.
Outcome measures
| Measure |
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
\[Cohort 1\] Patients receive tenofovir alafenamide (TAF) orally (PO) once daily (QD) or tenofovir disoproxil fumarate (TDF) PO QD or entecavir PO QD immediately or within 42 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.
|
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
\[Cohort 1\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
n=2 Participants
\[Cohort 2\] Patients receive TAF PO QD or TDF PO QD or entecavir 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.
|
Arm 4 (Anti-Viral Therapy: Usual Care)
n=2 Participants
\[Cohort 2\] Patients receive anti-HBV therapy at the discretion of the physician. Any Food and Drug Administration (FDA) approved anti-viral medication for treatment of HBV may be utilized.
|
|---|---|---|---|---|
|
Combined Endpoint of Adverse Liver Outcomes and HBV Reactivation, Number of Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1 (TAF, TDF, Entecavir: Prophylactic)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2 (TAF, TDF, Entecavir: Upon Indication)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3 (TAF, TDF, Entecavir: Upon Indication)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4 (Anti-Viral Therapy: Usual Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
SWOG Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60