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A prospective, pragmatic post-authorisation safety study of early recurrence of hepatocellular carcinoma in hepatitis C virus-infected patients after direct-acting antiviral (DAA) therapy: DAA-PASS
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DAAs Not Tied to HCC Recurrence After Successful HCC Therapy
EASL Congress 2023, June 21-24, Vienna
Mark Mascolini
A US-European prospective observational study did not link direct-acting antiviral (DAA) therapy for HCV infection to recurrent hepatocellular carcinoma (HCC) in people with earlier successful HCC treatment [1]. But a small sample size limits the weight of this finding.
Initial studies of DAA therapy raised worries that treatment may boost the risk of early and aggressive HCC recurrence. European drug authorities recommended that DAA developers explore this risk in people starting DAA therapy after successful treatment of HCC.
To address this concern, researchers conducted a prospective, longitudinal, observational study called DAA-PASS. Participants had HCV monoinfection, no previous DAA therapy, and a radiologically confirmed complete response to treatment of stage BCLC-A (early-stage) liver cancer. The study did not randomly assign participants to immediate versus delayed DAA therapy. Rather, treating clinicians started DAA therapy at their discretion. Follow-up with regular imaging to spot HCC recurrence continued from an index date defined as the date of first radiologically confirmed complete response to HCC therapy.
Investigators in the United States and Europe began collecting data in March 2018, planning to enroll 600 people with chronic HCV who had a complete response to HCC treatment and had not yet begun a DAA regimen. When data collection ended in June 2021, they had screened 222 people with HCC but had to exclude 180 who did not meet enrollment criteria, including 74 not in the correct BCLC stage and 61 who took a DAA before the documented complete response of HCC.
The small number of people screened and the large number of exclusions resulted in a sample size of only 42. These people had a median age of 62 years when diagnosed with HCC, 79% were men, and 74% white. A large majority, 95%, had cirrhosis, and 45% had hepatic decompensation. Three quarters of the group (74%) received locoregional therapy for HCC, while 17% had surgical resection.
Twenty-four of the 42 participants (57%) got DAA therapy for a median 2.8 months, and follow-up from starting DAAs stood at a median 18.9 months. Ten people had recurrent HCC during follow-up-5 DAA-treated people (incidence 23%) and 5 people not treated with DAAs (incidence 37%). HCC recurrence at 24 months stood at 17.7 cases per 100 person-years, and statistical analysis showed no greater risk of recurrence in the DAA-treated group (hazard ratio 0.6, 95% confidence interval 0.2 to 2.2; age-adjusted hazard ratio 0.7, 95% confidence interval 0.2 to 2.3). Researchers tallied no recurrences at 3 months, 5 at 6 months, 7 at 9 months, 7 at 12 months, 9 at 18 months, and 10 at 24 months.
DAA-PASS investigators noted that the sample size fell far short of the target number because legions of people with HCV in the US and Europe began DAAs soon after their efficacy became known. Few people remained naive to DAAs after successful HCC treatment. But with that limitation in mind, the researchers believe their study "suggests DAA therapy is not associated with an increased risk of HCC recurrence among patients with previous successfully treated HCC."
Reference
1. Singal A, Fried MW, Colombo M, et al. A prospective, pragmatic post-authorisation safety study of early recurrence of hepatocellular carcinoma in hepatitis C virus-infected patients after direct-acting antiviral (DAA) therapy: DAA-PASS. EASL Congress 2023, June 21-24, Vienna. THU-185.
Singal A1, Fried MW2, Colombo M3, Mospan AR2, Morris HL2, Cabrera R4, Kelley K5, Mehta N6, Sangro B7 on behalf of TARGET-HCC/DAA-PASS Investigators
1UT Southwestern, Dallas, TX, USA; 2Target RWE, Durham, NC, USA; 3Humanitas Hospital, Italy; 4University of Florida, Gainesville, FL, USA; 5University of California San Francisco, San Francisco, CA, USA; 6Cleveland Clinic, Cleveland, OH, USA; 7Clinica Universidad de Navarra, Spain
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