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The Impact of Direct-Acting Antiviral Therapy on End-Stage Liver Disease Among Individuals with Chronic Hepatitis C and Substance Use Disorders
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August 2021 Hepatology - Haesuk Park ,1 Xinyi Jiang ,1 Hyun Jin Song ,1 Vincent Lo Re III,2 Lindsey M. Childs- Kean ,3
Wei- Hsuan Lo- Ciganic ,1 Robert L. Cook ,4 and David R. Nelson
"less than one-fourth of HCV patients with an SUD initiated DAA therapy......
all those with HCV and an SUD should receive DAA treatment, and it is important to develop strategies that complement the initiation of DAA treatment and treatment of SUD, especially for those with an alcohol use disorder.....
For both groups of patients, those with and without an SUD, treatment with DAAs resulted in a lower incidence of DCC and HCC when compared with no treatment; this finding further confirms the recommendations of the current treatment guidelines that suggest that HCV antiviral therapy is feasible in patients with an SUD and should be provided as indicated to avoid the development of liver complications"
In conclusion, despite the availability of effective all-oral DAA therapies, the rate of DAA prescribed treatment is much lower among patients with HCV and an SUD compared with patients with HCV without an SUD. The incidence rates for DCC and HCC were higher for those with an SUD compared with those without an SUD, but treatment with DAA therapy was significantly associated with a decreased risk for DCC and HCC. Our findings suggest that all those with HCV and an SUD should receive DAA treatment, and it is important to develop strategies that complement the initiation of DAA treatment and treatment of SUD, especially for those with an alcohol use disorder..
This retrospective cohort study provides U.S. population-based evidence for the effects of all-oral DAA therapy on the incidence of DCC and HCC among a specific but growing population of patients who are infected with HCV: those with an SUD. Despite the National Viral Hepatitis Action Plan that prioritizes efforts to focus on improving access to care and treatment among HCV patients with an SUD,(31) less than one-fourth of HCV patients with an SUD initiated DAA therapy.
For both groups of patients, those with and without an SUD, treatment with DAAs resulted in a lower incidence of DCC and HCC when compared with no treatment; this finding further confirms the recommendations of the current treatment guidelines that suggest that HCV antiviral therapy is feasible in patients with an SUD and should be provided as indicated to avoid the development of liver complications.(32) These results continue to be very encouraging because they help confirm prior studies that showed that patients with an SUD who are treated for HCV can achieve similar adherence and SVR rates(10-14) to patients without an SUD, countering arguments that have been commonly used to limit treatment access in the patient population with an SUD.(33, 34)
injection drug use, which is the most common risk factor for contracting HCV, accounts for ∼75% of newly acquired cases of HCV and ∼50% of cases of chronic HCV infection.(1, 2) In addition, the majority of patients infected with HCV also have an alcohol use disorder, which is highly associated with concomitant use of illegal substances, leading to an increased risk for HCV. In light of the opioid crisis among young persons, the U.S. Centers for Disease Control and Prevention (CDC) reported that the number of cases of acute HCV more than tripled between 2010 and 2016.(5, 6) As a result, the CDC and the U.S. Preventive Services Task Force have now changed their HCV testing recommendations to test all those over the age of 18 once and those with high-risk factors, such as an SUD, annually...... the possibility of a cure for chronic HCV is now feasible. HCV treatment took a major step forward in 2013 with the introduction of highly efficacious all-oral direct-acting antiviral (DAA) interferon-free treatments. Treatment with DAAs has a therapeutic efficacy in more than 95% of patients across the 4 major HCV genotypes and can be administered to groups of patients for whom interferon is contraindicated (e.g., those with SUD and pre-existing medical conditions). In several clinical trials and observational studies, patients with an SUD enrolled in an opioid treatment program who were treated with DAAs achieved equally high sustained virologic response (SVR) rates as treated patients without an SUD.(10-16) Such results now provide the opportunity for the United States to work toward the HCV elimination goals established in the 2017-2020 National Viral Hepatitis Action Plan. Nevertheless, patients with HCV and an SUD continue to be undertreated.(17-19) As a result, patients with chronic HCV and an SUD may be at higher risk for developing end-stage liver disease, specifically, decompensated cirrhosis (DCC) and HCC, compared with those without an SUD. However, little is known about the effects of DAAs on clinical outcome data (DCC and HCC) among this cohort of patients. Therefore, using a large national insurance database, we evaluated the effects of DAA therapy on the incidence of DCC and HCC in patients who are chronically infected with HCV with an SUD compared with those without an SUD.
Abstract
Background and Aims
Our aim was to evaluate the impact of direct-acting antivirals (DAAs) on decompensated cirrhosis (DCC) and HCC in patients with chronic HCV and substance use disorder (SUD) compared with those without an SUD.
Approach and Results
This retrospective cohort study used the MarketScan database (2013-2018) to identify 29,228 patients with chronic HCV, where 22% (n = 6,385) had ≥1 SUD diagnosis. The inverse probability of treatment weighted multivariable Cox proportional hazard models were used to compare the risk of developing DCC and HCC.
Among the those who were noncirrhotic, treatment reduced the DCC risk among SUD (adjusted hazard ratio [aHR] 0.13; 95% CI, 0.06-0.30) and non-SUD (aHR 0.11; 95% CI, 0.07-0.18), whereas the risk for HCC was not reduced for the SUD group (aHR 0.91; 95% CI, 0.33-2.48).
For those with cirrhosis, compared with patients who were untreated, treatment reduced the HCC risk among SUD (aHR, 0.33; 95% CI, 0.13-0.88) and non-SUD (aHR, 0.40; 95% CI, 0.25-0.65), whereas the risk for DCC was not reduced for the SUD group (aHR, 0.64; 95% CI, 0.37-1.13). Among patients with cirrhosis who were untreated, the SUD group had a higher risk of DCC (aHR, 1.52; 95% CI, 1.03-2.24) and HCC (aHR, 1.69; 95% CI, 1.05-2.72) compared with non-SUD group.
Conclusions
Among the HCV SUD group, DAA treatment reduced the risk of DCC but not HCC for those who were noncirrhotic, whereas DAA treatment reduced the risk of HCC but not DCC for those with cirrhosis. Among the nontreated, patients with an SUD had a significantly higher risk of DCC and HCC compared with those without an SUD. Thus, DAA treatment should be considered for all patients with HCV and an SUD while also addressing the SUD.
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