DAAs with, without PIs yield similar outcomes in decompensated HCV cirrhosis
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SAN DIEGO — Researchers reported similar clinical outcomes in patients with decompensated hepatitis C virus cirrhosis treated with direct-acting antivirals, with or without protease inhibitors, according to study results.
“The current study reflects real world practice on PI-based DDAs where physicians may choose to initiate PI-based DAAs in view of limited treatment options besides liver transplantation, even if this is beyond the current approved indications,” Yu Jun Wong, MD, of Stanford University, said during a presentation at Digestive Disease Week 2022. “Plus, our cohort consists of a wide range of HCV genotype and DAA regimen, thus making our findings generalizable in the clinical setting.”
Wong and colleagues identified 15,554 patients from the REAL-C registry, a collective of real-world patients on DAAs from the United States, Europe, and Asia Pacific, 935 of whom had decompensated HCV cirrhosis (mean age, 64 years; 59.6% men; from 27 sites), within 6 months of DAA initiation. The percentage of patients with clinically meaningful worsening or improvement [at least 2-point increase or decrease or in Child-Turcotte-Pugh/Model-of-End Stage-Liver-Disease (CTP/MELD)] or at least one CTP class change, respectively, served as the primary outcome. Other outcomes included sustained virologic response (SVR) at 12 weeks (SVR12), SVR at 24 weeks (SVR24), percent of new liver-related events (clinical decompensation or hepatocellular carcinoma) and death.
According to results, baseline mean CTP and MELD scores were 6.5 and 13, respectively, and 45% of patients were treated with a PI-based DAA. Patients in the PI cohort were more likely to have GT1, chronic renal disease and a higher MELD score (P < 0.05 for all), compared with the non-PI cohort.
Among patients given PI-based DAAs, the SVR12 rate was 93.8% and the SVR24 rate was 90.6%, whereas in patients who did not receive PI-based DAAs, the SVR12 and SVR 24 were 88.8% and 89.8%, respectively. At posttreatment weeks 12 and 24, the clinically meaningful worsening in CTP and MELD scores were similar and not significant between patients on PI-based DAAs and non-PI-based DAAs (17.2% vs. 15.6%, and 14.5% vs. 19.4%, respectively).
Further, the frequency of new HCC, decompensating events and death were all similar between patients on PIs-based DAAs and non-PI-based DAAs at posttreatment week 24.
“[In] this large, multinational real-world cohort of diverse patients with decompensated HCV cirrhosis, we found similar rates of significant worsening in terms of CTP score and MELD score between patients treated with PI vs. non-PI-based DAA,” Wong said. “The frequency of liver-related events, clinical decompensations, HCC and death were also similar between the two groups.”
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Wong, et al. Abstract 328. Presented at: Digestive Disease Week; May 21-24, 2022; San Diego (hybrid meeting).
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