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There are special considerations regarding patients with HCV from ethnic minorities that may help us justify the extra effort it may take to fully engage some of these populations. In my practice in the United Kingdom, we do see significantly more genotype 3 disease in people of Pakistani and Indian origin, which together form a significant part of our immigrant population. We now know very clearly that genotype 3 disease is associated with increased risk of liver cancer and metabolic syndrome rates.
Therefore, it is not infrequent that in a transplant center, like the one I work with, we see people in their 30s presenting de novo with decompensated liver cirrhosis caused by hepatitis C genotype 3 that they have almost certainly had for 30 years, since they were children.
I think this is often exacerbated by the fact that these patients have a BMI that is below that for overweight or obese. We are increasingly recognizing that the BMI thresholds that were largely derived in the White population do not apply in people from different ethnic backgrounds. It is an obvious failure of our healthcare systems that we still see people presenting with very advanced disease who require transplantation.
This slide illustrates a retrospective study by Kanwal and colleagues14 that investigated sustained virologic response (SVR) after DAAs in relation to rates of hepatocellular cancer (HCC). Using retrospective review of 2 large datasets—the US Department of Veterans Affairs Corporate Data Warehouse and the Central Cancer Registry—researchers reviewed data for 25,232 patients who received DAA therapy between January 1, 2015, and December 31, 2015, with follow-up for HCC until September 30, 2018. Of these, 1948 patients were excluded because SVR status could not be determined. Also excluded were 705 who had evidence of HCC prior to therapy, 79 who developed HCC during therapy, and 4424 who did not achieve SVR 12 weeks after treatment completion.
Of the 18,076 evaluable patients, the mean age at treatment initiation was 61.6 years (standard deviation: 6.1 years), and the majority were men (96.5%); 49.6% were White and 36.5% were Black. At baseline 38.4% had cirrhosis and 11.7% had advanced fibrosis. HCC incidence rates from 1.5 to 2.3 per 100 person-years in patients with cirrhosis, resulting in cumulative incidence of HCC of 2.2% in Year 1, 3.8% in Year 2, and 5.6% in Year 3 for this group. This was a 4.1-fold increased risk compared with patients who did not have cirrhosis at baseline. Of interest, Black patients had decreased risk of HCC compared with White patients (adjusted HR: 0.74; 95% CI: 0.60-0.92).
Hispanic patients, as we have already mentioned, have a significantly higher risk of mortality from liver disease. The first US large-cohort study to look at the effects of metabolic syndrome on liver-related complications in patients with chronic HCV infection was conducted by Wong and colleagues.15 Of the 3503 total patients with chronic HCV infection and cirrhosis, 238 (6.7%) developed HCC. Of these, 49% had baseline decompensation. Of the 51% who did not have baseline decompensation, 25.2% (n = 488) developed hepatic decompensation over 8 years of follow-up.
The hepatic decompensation in Hispanic patients vs non-Hispanic patients was found to be significantly higher, with 8-year incidence of 66.1% vs 59.3% (P = .047), respectively. That is especially the case with people without an SVR, with an adjusted HR of 2.53.
Hispanic patients with HCV and 2 or more metabolic risk factors, such as diabetes, high blood pressure, and metabolic syndrome, have a 1.89% increased chance of liver decompensation compared with non-Hispanic patients who have the same metabolic risk factor profile. Even those Hispanics without metabolic risk factor profiles have a 1.42 adjusted HR of decompensation.
There is something driving the increasing risk of decompensation in Hispanic individuals. Regardless of whether you are approaching this from a cost-effectiveness perspective or through an equity lens, increased screening efforts in this population are justified in order to diagnose infection earlier, prevent liver decompensation, and hopefully cure.
Not only do we get increased amounts of decompensation and of cirrhosis incidence, but there is also an increased incidence of HCC in Hispanic patients, again justifying spending time, resources, and money in screening, curing, and preventing complications in this subpopulation. The 8-year HCC incidence of HCC for Hispanic patients in the Wong study discussed on the previous slide was 28.4% (3.4/100 person-years (PY)) compared with 18.4% (2.44/100 PY) for non-Hispanic patients (P = .013).15
There was also an increased risk of HCC for Hispanic patients with HCV demonstrated in this study by Hashem El-Serag, who is well known in the HCC field.16 El-Serag and colleagues examined a very large cohort of patients with active HCV viremia between 2000-2009, with at least 1 year of follow-up, using the Veterans Administration HCV Clinical Case Registry.
Of all patients, 3551 had developed HCC after an average follow-up of 5.2 years, with Hispanic patients having the highest incidence rate (7.8%) of all ethnic groups (non-Hispanic White patients: 4.7%; Black patients: 3.9%).
Another interesting subgroup is Asian patients infected with genotype 6 HCV. These patients are most commonly found in regions such as Vietnam. Compared with Asian patients with genotypes 1, 2, 3, and 4 combined, those with genotype 6 have an increased risk of HCC, as demonstrated on the slide.
You can see that the odds ratio is double that for patients with nongenotype 6 disease. Again, these data reinforce the need for focused screening in populations with rare genotypes because they seem to be associated with more pathogenic disease and more development of cancer moving forward.