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High Virologic Cure Rates for Hepatitis C Virus among Veterans with Opioid Use Disorder Treated with Elbasvir/Grazoprevir
Elbasvir (EBR)/grazoprevir (GZR) is a fixed-dose combination treatment for hepatitis C virus (HCV). This study sought to evaluate the real-world effectiveness of EBR/GZR among Veterans with HCV genotype (GT) 1 who also had a diagnosis of opioid use disorder (OUD). Findings showed that high rates of virologic cure were achieved among VA patients with HCV, OUD, and multiple comorbidities, including very high rates of psychiatric medication use, after receiving EBR/GZR for 12 weeks. Overall, 97% of Veterans achieved sustained virologic response (SVR). SVR rates were high regardless of baseline characteristics, comorbidities, or concomitant medications. SVR was achieved by 95% of Veterans receiving medication for OUD (MOUD) – and by 98% of Veterans who were not receiving MOUD. A total of 128 Veterans were reported as homeless during the year prior to initiating treatment; 98% of those Veterans achieved SVR. This first real-world evaluation of EBR/GZR in a population of patients with OUD suggests that treatment for 12 weeks represents an effective option for patients with HCV GT1 infection receiving MOUD, including people who inject drugs.
Date: January 25, 2022
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Veterans Advocate Treating “Sickest First” When Discussing Limited Resources for Hepatitis C Treatment
Investigators in this study used Democratic Deliberation (DD) methods as a proof of concept for informing policy decisions related to the allocation of scarce resources for treatment of chronic hepatitis C virus in VA. Findings showed that most Veterans endorsed a sickest-first policy over a first-come-first-served policy, emphasizing the ethical and medical appropriateness of treating the sickest Veterans first. When given the option, almost two-thirds of participants insisted that all Veterans be treated without delay regardless of symptoms or degree of disease severity (note: this is currently VA policy but not common outside of VA). Only when required to choose between the two policies did a majority opt for the SF policy (86% before DD session; 93% after DD session). Veterans also suggested modifications to the “sickest first” policy: 1) need to consider additional health factors, 2) taking behavior and lifestyle into account, 3) offering education and support to overcome barriers to treatment, 4) improving access to testing/treatment, and 5) improving how allocation decisions are made. The approach of using DD to incorporate the opinions of patients may have implications for how to develop policies around allocation of limited healthcare resources during the current COVID-19 pandemic.
Date: May 1, 2020
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VA Successfully Implements Interferon-free Treatment for Hepatitis C Virus in Previously Undertreated Patient Populations
This study examined the adoption of interferon-free treatment for hepatitis C virus (HCV) in VA to learn who received this therapy and whether the limitations of interferon-containing treatments have been overcome, including low rates of use among VA healthcare users who are African American or Hispanic, and among those with HCV-HIV co-infection. Findings showed that with the advent of interferon-free regimens, the percentage of VA patients with HCV infection that was treated increased from 2% in 2010 to 18% in 2015, an absolute increase of 16%. There were large treatment gains realized by groups of patients that had been less likely to be treated in 2010. Large absolute increases in the percentage treated were achieved in Veterans with HIV co-infection (19%), alcohol use disorder (12%), and drug use disorder (13%), and in Veterans who were African-American (14%) or Hispanic (14%). Veterans with mental illnesses exacerbated by interferon, depression, PTSD, and bipolar disorder, had absolute increases in treatment that were larger than the overall increase.
Date: March 7, 2018
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HCV-Related Complications Increasing among Women Veterans
This study examined gender-related differences in the incidence and prevalence of cirrhosis, decompensated cirrhosis, and hepatocellular cancer (HCC) between 2000 and 2013. Findings showed that the incidence and prevalence of hepatitis C virus (HCV) complications was higher in men than in women. However, the rate of increase in the incidence rates of cirrhosis and decompensated cirrhosis among HCV-infected women is similar to the rate of increase in men. In 2000, 3% of women vs. 5% of men had been diagnosed with cirrhosis. By 2013, the prevalence for cirrhosis had risen to 14% and 21% in women vs. men, respectively. In 2000, the prevalence of decompensated cirrhosis was 1.6% in women and 2.4% in men, but increased by 2013 to 7% in women and 12% in men.
Date: November 1, 2017
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Direct-Acting Antiviral Agents Reduce Risk of Hepatocellular Cancer among Veterans with Hepatitis C
This study examined the risk of hepatocellular cancer (HCC) following sustained virological response (SVR) among 22,500 Veterans with hepatitis C virus (HCV) who received directing-acting antivirals (DAA) treatment at any of 129 VA hospitals between January and December 2015. Findings showed that in Veterans treated with DAAs, SVR was associated with a 76% reduction in the risk of developing hepatocellular cancer compared to those who did not achieve SVR. This benefit persisted even after accounting for demographic and clinical variables. Patients with cirrhosis had the highest annual incidence of HCC after SVR, ranging from 1% to 2% per year based on other demographic and clinical characteristics. In contrast, the risk of HCC was low in almost all Veterans without cirrhosis, with the exception of patients with findings suggesting the presence of advanced fibrosis. There was no evidence to suggest that DAAs promote HCC either during or after treatment completion, as some previous studies have suggested.
Date: October 1, 2017
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VA Hepatitis C Care and Experiences with the Choice Program
This study examined perspectives and experiences with the VA Choice Program among Veterans with HCV and their providers at three VAMCs in the New England region. Findings showed that the Choice Program has the potential to increase Veterans’ access to hepatitis C virus (HCV) treatment, but Veterans and VA providers described substantial problems in the initial years of the program. Four main themes emerged: (1) Difficulties in enrollment, ongoing support, and billing with third-party administrators (i.e., many Veterans described confusion about eligibility and enrollment for the Program); (2) Veterans experienced a lack of choice in location of treatment (i.e., most Veterans at the study sites did not have the option to receive VA HCV treatment, but many wanted to); (3) Fragmented care led to coordination challenges between VA and community providers (i.e., various challenges arose around sharing medical records, prescription delays, and working with designated VA staff trained on the Choice Program); and (4) VA providers expressed reservations about sending Veterans to community providers (i.e., VA providers were cautious about sending patients to the Choice Program because some community providers lacked specific experience in treating advanced cases of HCV).
Date: March 3, 2017
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Engagement in Hepatitis C Virus Care among Homeless and non-Homeless VA Patients
This study sought to describe engagement in hepatitis C virus (HCV) care among homeless and non-homeless Veterans in the new era of HCV treatment, which includes direct-acting agents (DAAs) with shorter treatment durations, fewer side effects, and higher sustained virologic response (SVR) rates than the older treatment regimens. Findings showed that VA providers do a better job of testing for and diagnosing chronic HCV infection among homeless Veterans than they do among non-homeless Veterans: 90% of homeless Veterans who were estimated to have chronic HCV were diagnosed by laboratory testing compared with 77% of non-homeless Veterans. The percentage of the total homeless population with chronic HCV infection who had ever received HCV antiviral therapy (23%) was lower than the percentage of the total non-homeless population who had ever received HCV antiviral therapy (31%). However, the cumulative SVR rates achieved among homeless Veterans who had ever received HCV antiviral therapy (68%) and non-homeless Veterans who had ever received HCV antiviral therapy (74%) were comparable. Efforts are needed to identify appropriate interventions to ensure that more homeless Veterans are candidates for HCV antiviral therapy. Homelessness should not necessarily preclude receipt of HCV antiviral therapy as the direction of future HCV care and treatment eligibility criteria with all-oral DAA regimens is considered.
Date: March 1, 2017
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VA Pharmacy Use in the First Year of Choice Act
This study sought to describe pharmaceutical use during the first year of the Veterans Choice Program (VCP) and to understand barriers and facilitators for VA pharmacists to dispensing medications under the VCP. Findings showed that a majority of VCP pharmacy spending in the first year was for hepatitis C virus (HCV) medications, which accounted for only 5% of prescriptions but 90% of costs. However, in 2015, VA experienced greater than expected demand for HCV medications, which exceeded available funding, thus some patients obtained medications through the VCP. The impact of HCV medications on the VCP should be short-lived given broadened availability in VA in 2016. Topical eye drops and opioids represented the most commonly dispensed prescriptions: 16% and 9% of all prescriptions, respectively.
Most prescriptions dispensed (93%) were for formulary agents, but substantial efforts were required from VA pharmacists to work with non-VA providers to use formulary drugs. Challenges related to obtaining medications from VA pharmacies through VCP included requiring controlled substance prescriptions to be hand-delivered, a lack of access to lab data required to safely dispense medications, and substantial time required by pharmacists to communicate with non-VA providers. Safe use of opioids, efficient management of non-formulary medications, and unintended new barriers to access created by the VCP must be addressed, in addition to robust ongoing evaluations to identify new cost, quality, and safety concerns.
Date: February 17, 2017
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Cost-Effectiveness of New Hepatitis C Virus Treatments in VA and Non-VA Patient Populations
This study analyzed the cost-effectiveness of multiple new hepatitis C virus (HCV) treatments for VA and non-VA treatment-naïve patients, accounting for differences in patient characteristics and costs of ongoing care and current drug prices, as well as potential reductions in these prices. Findings showed that in the non-VA HCV population, the latest generation of highly effective but costly HCV treatments delivers good value – comparable to other medical interventions commonly deemed high value. HCV treatment is even more cost-effective in VA’s patient population due to VA’s lower costs of drugs, despite patients being older with more comorbid conditions.
Date: October 3, 2016
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Antiviral Treatment Reduces Risk of Cirrhosis, Hepatocellular Cancer and Mortality among Veterans, Irrespective of Age
This study examined the association between age subgroups and risk of cirrhosis, hepatocellular cancer (HCC), or death among Veterans who tested positive for the hepatitis C virus (HCV), including those who received treatment in VA facilities. Findings showed that receipt of curative antiviral treatment was associated with a reduction in the risk of cirrhosis, HCC, and overall mortality, irrespective of age. Elderly Veterans were significantly less likely to receive antiviral treatment; however, among those who received treatment, sustained virological response was not different among the age groups, even after adjusting for other demographic and clinical factors, including comorbidities. Given the accelerated progression to advanced liver disease, elderly patients with chronic hepatitis C constitute a high-risk group that may need to be prioritized in the era of new antiviral treatments.
Date: April 3, 2016
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Hepatitis C Virus Genotype 3 Associated with Increased Risk of Cirrhosis and Hepatocellular Cancer among Veterans
Investigators in this study identified 110,484 Veterans with chronic Hepatitis C virus (HCV) infection and an average follow-up of more than five years to examine the differences between HCV genotypes in the risk of progression to cirrhosis and hepatocellular cancer (HCC). Findings showed that HCV genotype 3 (present in 8% of all cases) was associated with a significantly increased risk of developing cirrhosis and HCC compared to HCV genotype 1 (80% of cases). Veterans with HCV genotype 3 were 31% and 80% more likely to develop cirrhosis and HCC, respectively, compared to Veterans with the most common HCV genotype 1 infection. Genotype 3 has traditionally been considered easier to treat than genotype 1 infection. Investigators found that a significantly higher proportion of Veterans with genotype 3 received and subsequently responded to antiviral treatment than those with genotype 1. However, this therapeutic advantage did not counterbalance the negative impact of genotype 3 on cirrhosis and HCC. Given the accelerated progression to advanced liver disease, patients with HCV genotype 3 may serve as a high-risk group that will need to be prioritized in the era of new antiviral treatments.
Date: February 24, 2014
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VA HIV and Hepatitis C Telemedicine Clinics Improve Patient Outcomes among Rural Veterans
Among a rural-dwelling study sample, HIV and hepatitis C telemedicine clinics were associated with improved access, high patient satisfaction, and a reduction in health visit-related time. Clinic completion rates (proxy for access) were higher for telemedicine (76%) than for in-person visits (61%). Of the 43 Veterans in the study, 30 (70%) completed a telemedicine-facilitated survey. More than 95% of these Veterans rated telemedicine at the highest level of satisfaction and preferred telemedicine to in-person visits. Veterans estimated that total health visit time was 340 minutes less for telemedicine compared to in-person visits. The majority of perceived time reduction was related to travel.
Date: April 1, 2012
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Chronic Conditions among Veterans and Related VA Healthcare Spending Trends: 2000-2008
This study estimated the change in prevalence and total VA spending for 16 chronic conditions (e.g., hypertension, diabetes, heart conditions, depression, PTSD, renal failure, cancer) between 2000 and 2008. Findings showed that most of the total VA spending increases during the study period were driven by the increase in VA’s patient population – from 3.3 million in 2000 to 4.9 million in 2008. In addition, the prevalence of many chronic conditions among VA patients increased as the VA population got older. Spending on renal failure increased the most, by more than $1.5 billion, with 66% of this increase related to greater prevalence of the disease. Spending increases for other conditions, such as hepatitis C, stroke, hypertension, diabetes, PTSD, and depression were also driven in large part by higher prevalence among VA patients. Higher treatment costs did not contribute much to higher spending; instead, lower costs per patient for several conditions may have helped to slow spending. During this time period, VA continued to expand its outpatient care system with community-based outpatient clinics; better access to outpatient care may have shifted costs away from more expensive inpatient care.
Date: December 1, 2011
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Rates of Liver Cancer and Cirrhosis Increase Significantly among Veterans with Hepatitis C Virus
This study identified all Veterans with hepatitis C virus (HCV) who visited any of 128 VA medical centers over a 10-year period to examine the prevalence of cirrhosis, hepatic decompensation, and hepatocellular cancer, as well as risk factors that may be associated with an accelerated progression to cirrhosis. The number of Veterans diagnosed with HCV increased over the ten years from 17,261 to 106,242. Over the same time period, among HCV patients, the prevalence of cirrhosis increased from 9% to 18.5%, while the prevalence of liver cancer increased approximately 19-fold (from 0.07% to 1.3%). Regarding risk factors among HCV-infected Veterans, the proportion of patients with co-existing diabetes increased from 12% in to 23%, while the number of patients with HIV, hepatitis B virus, or a diagnosis of alcohol use declined slightly.
Date: December 22, 2010
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Patients with Hepatitis C Benefit from Collaborative Care
This study evaluated the quality of healthcare that patients (non-Veterans) with Hepatitis C (HCV) receive and factors associated with receipt of quality care, using research data from one of the largest commercial health insurance carriers in the U.S. Findings show that collaboration between specialists and primary care physicians translates into better care for patients with HCV. Patients were less likely to receive any recommended care if they were being treated by specialists or generalists only, compared with being seen by both. Only about 19% of patients with HCV received all recommended care, and the proportion of patients who met quality indicators varied substantially. For example, most patients (79%) received a genotype test before treatment, whereas relatively few (25%) received recommended vaccinations.
Date: August 17, 2010
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Self-Management Program for Veterans with Hepatitis C Improves Health, Independent of Antiviral Therapy
This randomized controlled trial sought to examine the effects of a Hepatitis C (HCV) self-management intervention on the quality of life of Veterans with HCV who were not currently on or scheduled to start antiviral treatment. Findings show that the HCV Self-Management Program was well attended and produced significant improvements along a number of dimensions of quality of life and other outcomes six weeks later. When compared to the information-only group, Veterans who attended the self-management workshop improved more on HCV knowledge, self-efficacy, and had more energy and vitality.
Date: May 31, 2010
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Chronic Kidney Failure Associated with Increased Mortality among Veterans with HIV and Hepatitis C Virus
Compared with their mono-infected counterparts, Veterans with HIV who were co-infected with HCV had significantly higher rates of chronic kidney disease (14% vs. 11%) and mortality. HCV co-infection independently increased the likelihood of death by nearly 25%, after adjusting for other important HIV- and HCV-related factors. Co-infected Veterans also were less likely to have received highly active antiretroviral therapy (HAART) at baseline. Authors suggest that efforts should be targeted toward optimizing medical care for mono- and co-infected Veterans, including HAART therapy, HCV antiviral therapy, and treatment of comorbid medical conditions.
Date: February 1, 2010
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Areas for Mental Health Intervention for Patients with Hepatitis C
In addition to the physiological side effects of treatment for the hepatitis C virus (HCV), there also can be significant neuropsychiatric effects such as depression, anxiety, psychosis, and suicidality. Moreover, numerous studies have documented the high prevalence of pre-existing psychiatric disorders among patients with HCV. This article reviews the psychological and psychosocial issues that are relevant to patients with HCV and provides mental health treatment recommendations. Some of these issues include stigma (i.e., more than half diagnosed with HCV have experienced discrimination) and social support. The authors also identify areas in which clinicians can intervene, including adjustment to having a chronic medical illness, management of side effects, and implementing healthy lifestyle recommendations.
Date: March 1, 2009
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Low Rates of Hepatitis Vaccination among Veterans with HCV
Among veterans diagnosed with HCV between 2000 and 2005, approximately 8% overall received hepatitis vaccination and 7% of those with cirrhosis were vaccinated. In veterans with HCV who did not receive hepatitis vaccinations, 66%-96% had hepatitis A or B serology checked and about one-third had negative serology indicating susceptibility to co-infection and missed opportunity for vaccination.
Date: November 1, 2008
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