Patients with HBV, HCV, or Both in the IMbrave150 Trial
This article responds to your request for information on the use of Tecentriq® (atezolizumab) in patients with hepatitis B (HBV), or hepatitis C (HCV), or both. This article contains data from published and unpublished sources.
Last updated August 31, 2023
Summary
- The Phase 3 IMbrave150 trial assessed the use of first-line Tecentriq in combination with Avastin versus sorafenib in patients with locally advanced or metastatic unresectable HCC.
- HBV and HCV infection levels in patients were assessed at trial enrolment:
- Patients were excluded from the IMbrave150 trial if they had both active HBV and active HCV.
- Patients with active, controlled HBV were included in the trial, if HBV was treated and HBV DNA <500 IU/mL within 28 days of trial initiation.
- Patients with active, controlled HCV infection were included in the trial.
- Nucleoside / nucleotide analogues and antivirals were used in IMbrave150 to treat HBV and HCV in the trial.
Abbreviations
HBV= Hepatitis B virus
HCC= Hepatocellular carcinoma
HCV= Hepatitis C virus
PCR= Polymerase chain reaction
IMBrave150 trial overview
IMbrave150 was a Phase 3, global, open-label, randomised study that evaluated the efficacy and safety of Tecentriq in combination with Avastin, versus sorafenib in 501 patients with locally advanced or metastatic unresectable HCC [1].
Eligible patients had to have
- no prior systemic therapy,
- Child-Pugh A liver cirrhosis,
- performance status of 0 or 1, and
- measurable disease per RECIST v1.1 not amendable to curative or locoregional therapies.
The IMBrave150 protocol provides a full list of additional inclusion and exclusion criteria [1].
Inclusion and exclusion criteria according to HBV and HCV status
Levels of HBV and HCV infection were assessed in patients at trial enrolment. Table 1 provides the inclusion and exclusion criteria for patients with HBV and HCV infection in the IMbrave150 trial.
Table 1. Inclusion and exclusion criteria in the IMbrave150 trial for patients wtih active HBV or HCV [1]
Patient characteristics at baseline
Table 2 provides data on the number of patients in the IMbrave150 trial who had HBV and HCV infection at baseline. As Table 1 shows, patients were not enroled to the trial if they had co-infection with both active HBV and active HCV.
Table 2. Patients receiving treatment for hepatitis in the IMbrave150 trial [2]
HBV and HCV medication
Table 3 provides data on the HBV and HCV medication administered to patients in the IMbrave150 trial.
Table 3. Number of patients with HBV and HCV infections in the IMbrave150 trial [2]
Efficacy and safety stratified by HBV and HCV status
Subgroup analyses of IMbrave150 safety and efficacy data for HBV and HCV patients was not performed [2].
References
- Finn R, Qin S, Ikeda M, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med 2020;382:1894-1905. https://www.ncbi.nlm.nih.gov/pubmed/32402160
- Roche Internal Clinical Study Report (Accessed July 2023).
Medinfo
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