Multiple regression analysis showed that the patient's annual income (P < .001), the severity of CHC (P < .001), and comorbidity (P < .001), such as HBV, HIV, and kidney disease were independent predictors of the patients’ not receiving antiviral therapy (Table 2 and Table S2, http://links.lww.com/MD/B839).
We further investigated the factors that influenced the choice of antiviral therapy between patients with different levels of income. Our results showed that in both low income (annual income <1610 dollars) and nonlow income patients (annual income> = 1610 dollars), the severity of CHC was all the independent risk factor. (Table S3, Table S4, http://links.lww.com/MD/B839).
The reasons given by chronic HCV infection patients for selecting to defer P/R antiviral therapy were shown in Fig. 3. The most common cause given by nearly one-thirds of patients was waiting for a better new drug. Factors relating to the P/R treatment regimen itself were identified as a reason for not wanting to initiate antiviral therapy in many patients, and the leading reason was the fear of side effects of interferon (27.5% [137/498]), followed by existing contraindication or being intolerance to interferon (21.7% [108/498]). Approximately 26.1% (130/498) patients selected personal economic unaffordable as the main reason that they did not want to be treated.
3.3 Concerns, perception with anti-HCV treatment
Compared with patients receiving treatment, not receiving treatment patients had a higher cognitive impairment for anti-HCV treatment (Table 3). In particular, not receiving treatment patients had more obstacles than treatment group on “contraindications or intolerance to interferon (4.3 vs 5.8, P < .001) or ribavirin (4.0 vs 5.2, P < .001), and wanted to wait for new drugs to be marketed (3.8 vs 6.4, P < .001),” which presented with the receiving treatment group scores being less than 5 points, while no receiving group more than 5. We also found that despite the different degree, both group patients showed the fear of side-effect (6.2 vs 7.0, P < .001), and worrying the low success rate of P/R treatment (6.6 vs 7.2, P < .001) which presented with the scores being more than 5 points. Finally, in addition to treatment regimens, not receiving antiviral treatment patients still exist some other problems, such as poor recognition of HCV (5.4 vs 6.6, P < .001) and inadequate capacity to pay(5.3 vs 6.1, P < .001).
As shown above, the patient's annual income was the independent predictors of patients’ not receiving antiviral therapy, we further analyzed the differences in “concerns, perception with anti-HCV treatment” between low and nonlow income patients (Table S5, http://links.lww.com/MD/B839). We found that low-income patients had more obstacles than non-low income patients on “poor recognition of HCV (6.4 vs 5.6, P < .001)” and “fear of side-effects (6.8 vs 6.3, P = .012).” In addition, both group patients showed high obstacles on “worrying the low success rate of P/R treatment (7.0 vs 6.8, P
= .222)” and “treatment duration too long” (7.0 vs 6.6, P
= .040) which presented with the scores being more than 6 points.
3.4 Expectations about future treatment
Both groups of patients showed the similar strong expectations for new drugs with high efficacy, low side-effects and short duration in the future treatment (Table 4). Each expectation rated on a 10-point Likert scale, from 0 “not expecting” to 10 “very expecting.” Both groups showed expectations of up to 9 points or more in the 4 aspects: “improve therapeutic efficacy,” “shorten period of treatment,” “convenient, no need for no need for injection,” and “reduce side effects, improve safety.” All in all, the data indicated that the patients with HCV infection in mainland China are expecting more potent and well tolerance medication available soon.
HCV is a curable disease now.[12,13] Previously we have demonstrated that increasing the use of antiviral therapy for HCV in China can reduce the overall disease burden. Due to the high percentage of favorable host genotype IL-28B CC among Chinese patients, reported SVR rates of peg-IFN/RBV were relative higher than other ethnics. In spite of that, in present survey we first reported that a considerable proportion, nearly up to one third of CHC patients with chronic HCV infection declined currently available peg-IFN/RBV regimen. Not satisfied with peg-IFN/RBV treatment and expecting more potent and well tolerance medication were the major reasons. This finding will give data support for police maker of Chinese government.
In the survey, although fairly high proportions of chronic HCV infection patients reported being received antiviral treatment, 24.6% of chronic hepatitis C and 50.7% of HCV-associated cirrhosis and HCC reported receiving no treatment. Because of the aging of populations and delays in diagnosis and treatment of hepatitis C due to low public awareness of the disease, many Chinese patients seen in clinics are presented with advanced liver disease and loss the chance of P/R treatment. In this study, the proportion of patients with cirrhosis or HCC was as high as about 23.4%. As hepatitis C is a curable disease, earlier diagnosis and treatment would improve the outcome of HCV patients and will relief burden on the public health system in China. Therefore, it is necessary to strengthen publicity and education to improve the awareness of the importance of treatment for hepatitis C patients.
Comparison of baseline clinical and demographic characteristics between receiving treated and not receiving treated groups showed higher proportions of elder age, severe disease, and lower-income in not receiving antiviral therapy patients. This was consistent with previous studies in the United States and United Kingdom.[8,15] It is easy to understand that patients with elder age and severe liver disease always are more intolerable to peg-IFN/RBV treatment. Notably, though, fairly high proportions of patients reported being covered by China's major types of government health insurance, health insurance was still affecting the patient's treatment options (91.9% vs 94.8%, P = .029). The finding deserves further attention from government policy-makers. Other research has shown that lack of health insurance for HCV patients will directly affect the health consequences. One US study reported that during the years 2005 to 2009, uninsured HCV patients in the United States had a 49% to 72% greater chance of dying during a hospitalization than HCV patients who had insurance. Apart from the inadequate coverage of health insurance, economic pressures also formed one of obstacles to the antiviral treatment. In our study, up to 32.9% of not receiving antiviral treatment patients have an annual income of less than $1610, while that of receiving treatment less than 17.8%. A study done in the United States also indicates that one-half of HCV patients cited personal financial resources as a barrier to care, despite 90% of patients possessing medical coverage.
Comorbidity represents another significant barrier to HCV treatment. Factors such as kidney disease (P = .003), HBV (P = .015), and HIV (P = .025) all reduced the antiviral selection of HCV patients, except that diabetes mellitus (P = .105) had no effect on patient motivation. Combination with other diseases or coinfection increases the difficulty of treatment. Some diseases, such as severe renal damage, are not well fit for P/R antiviral therapy.[18–20] While for coinfection with HBV, the increased risk of HBV DNA reactivation followed by antiviral HCV therapy should be concerned. Similarly, for HIV coinfection, the treatment regimen is often complex and brings more challenges to both patients and physicians.
Across all global regions, patient-level factors were viewed as the greatest obstacles to treatment.[17,22–24] Specifically, fear of treatment-related side effects was the most frequently cited barrier.[25,26] Consistent with this, our analysis of the reasons for patients not receiving P/R antiviral therapy indicated that the top 2 were “waiting for a better new drug” (31.5%) and “the fear of adverse effects” (27.5%). Considering the potential toxicity, low SVR acquirement, and long treatment duration of P/R treatment, it is easy to understand our data showed that the expected future treatment from both groups should have short course, high efficacy, easy to use, etc. DAA drugs almost meet all the above requirements, and have brought innovative revolutions to anti-HCV treatment. So, our data strongly suggested DAAs are urgent in need in current mainland China.
This study has some limitations. First, it is a cross-sectional investigation that does not reflect the dynamic changes of anti-HCV treatment. Second, the questionnaire was collected from hospital, which might have some deviation from the real world. Despite all this, the present 56 hospitals survey has provided strong evidences for both understanding the current anti-HCV treatment status and forecasting the huge demand of new anti-HCV treatment in mainland China.
To reduce the HCV public burden in China, early diagnosis of hepatitis C infection followed by more effective treatment is the key elements to combat HCV. There were many barriers that impede prompt and appropriate treatment of HCV infection in China. So, strengthening publicity and education, improving the patient's awareness of treatment, and improving medical insurance coverage are needed to achieve affordable and effective treatment of HCV in mainland China. Moreover, safe and efficient DAAs are urgently needed to be introduced into China to facilitate the global strategy of fighting against HCV infection.
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DAAs; deferred treatment; HCV; patient satisfaction
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