HCV-infected People Who Inject Drugs Research Articles

Reduction in Depressive Symptoms in People who Inject Drugs who Are Cured of Hepatitis C Virus Infection: The HERO Study.

Depressive symptoms are prevalent among people who inject drugs (PWID) and people with hepatitis C virus (HCV). We examined changes in depressive symptoms among HCV-infected PWID following direct-acting antiviral treatments to evaluate whether these changes differed by history of depressive symptoms, substance use, or HCV treatment outcome. We conducted a secondary analysis of the HERO Study (NCT02824640), a pragmatic randomized clinical trial among PWID, to test the effectiveness of HCV care models. Depressive symptoms (primary outcome) were measured using the Patient Health Questionnaire (PHQ-9) at baseline, end of treatment (EOT), and at follow-up 12 and 24 weeks after EOT. Sustained virologic response (SVR) was defined as undetectable HCV RNA at ≥12 weeks following EOT. Baseline drug use was defined as having a positive urine screening test for amphetamine, methamphetamine, benzodiazepine, cocaine, cannabis, opiate, or oxycodone. The sample (n = 498) was 72.3% male, 64.2% White, and on average 43.9 years old. In patients who achieved SVR (F(3432) = 4.58; P = .004) and those with drug use at baseline (F(3478) = 5.11; P < .01), PHQ-9 scores significantly declined over time, with scores lower at EOT and both follow-ups as compared with baseline. Mean PHQ-9 scores at EOT and follow-ups were significantly lower than at baseline, except for those with no depression or mild depression at baseline. This study showed that HCV treatment in PWID is associated with sustained declines in depression up to 24 weeks post-treatment among those who achieve SVR and that drug use does not interfere with improvement in depressive symptoms.

Relationship between depressive symptoms and adherence to direct-acting antivirals: Implications for Hepatitis C treatment among people who inject drugs on medications for opioid use disorder

BackgroundInterferon-based regimens exacerbated depressive symptoms, which interfered with treating hepatitis C virus (HCV) among people who inject drugs (PWID). Direct-acting antivirals (DAA) are not associated with worsening depressive symptoms; however, the impact of depressive symptoms on adherence remains little known. We examined the association between depressive symptoms and adherence to DAA among HCV-infected PWID. A secondary aim was to identify the optimal cut-off for major depressive disorder for this population. MethodsParticipants were 150 HCV-infected PWID on maintenance treatment enrolled in a randomized clinical trial testing three HCV care models. Severity of depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) at baseline and every 4 weeks during treatment. Current major depressive disorder at baseline was diagnosed by the Mini-International Neuropsychiatric Interview. Adherence was measured during treatment (weeks 1–12) using electronic blister packs ResultsBDI-II scores ≥ 18 were identified as the optimal threshold for diagnosing major depressive disorder. Participants with BDI scores ≥ 18 at baseline had significantly lower adherence rates at weeks 1–4 of treatment compared to those with BDI scores < 18 (b = −0.23, 95% CI: 0.45–0.01, p = 0.044), but not in any other time intervals (weeks 5–8, b = −0.03, 95% CI: −0.32, 0.26, p = 0.825; weeks 9–12, b = −0.33, 95% CI −0.70, 0.02, p = 0.066). ConclusionsElevated depressive symptoms were associated with lower adherence to DAA only during the first 4 weeks of HCV treatment. Neither severe depressive symptoms nor major depressive disorder appears to be a barrier to DAA adherence among PWID.

Impact of an Accelerated Pretreatment Evaluation on Linkage-to-Care for Hepatitis C-infected Persons Who Inject Drugs.

Background:Historically, hepatitis C virus (HCV) pretreatment evaluation has required multiple visits, frequently resulting in loss to follow-up and a delayed initiation of treatment. New technologies can accelerate this process. We investigated the feasibility of a single-day evaluation program and its impact on evaluation completion, treatment eligibility awareness, and treatment initiation among people who inject drugs (PWIDs).Methods:HCV-infected PWID who were unaware if they were eligible for treatment were recruited in a prospective evaluation of an accelerated model of care between 2017 and 2019 and compared to a historical cohort. The patients underwent a medical evaluation, rapid HCV viral load testing, and transient elastography during a single visit, at the end of which they were informed whether they were eligible for treatment. A historical cohort of patients fulfilling the same inclusion criteria and evaluated with the usual standard of care spanning several visits who were examined at the addiction medicine clinic from 2014 to 2016 served as the comparison group.Results:The accelerated and historical cohorts included 99 and 76 patients, respectively. The cohorts did not differ significantly by age and gender, but more patients in the historical cohort were undergoing opioid agonist therapy, while more patients in the accelerated cohort injected drugs in the last month. An accelerated evaluation resulted in a higher rate of evaluation completion (100% vs 67.1%; P < .001). Among those eligible for treatment, the proportion of those initiating treatment was similar between the groups (51/64 (79.7%) vs. 26/37 (70.3%); P = .28). The delay in the initiation of treatment was shorter in the accelerated cohort than in the historical cohort (69 (IQR: 49-106) days vs. 219 (IQR: 141-416) days; P < .001).Conclusions:Accelerated evaluation enhanced the awareness of eligibility and reduced the time to initiation among eligible patients.Trial Registration:This study is registered on www.clinicaltrials.gov (NCT02755402).

Real-world outcomes of rapid regional hepatitis C virus treatment scale-up among people who inject drugs in Tayside, Scotland.

SummaryBackgroundIn 2017, Tayside, a region in the East of Scotland, rapidly scaled‐up Hepatitis C Virus (HCV) outreach and treatment among People Who Inject Drugs (PWID) using novel community care pathways.AimsWe aimed to determine treatment outcomes for PWID during the scale‐up against pre‐determined targets; and assess re‐infection, mortality, and post‐treatment follow up.MethodsHCV treatment was delivered in community pharmacies, drug treatment centres, nurse‐led outreach clinics, prisons, and needle exchanges, alongside conventional hospital care. We retrospectively analysed clinical outcomes and compared pathways using logistic regression models.ResultsOf 800 estimated HCV‐infected PWID, 718 (90%) were diagnosed. 713 treatments commenced among 662 (92%) PWID, delivering 577 (81%) Sustained Virologic Responses (SVR). SVR was 91% among those who attended for testing. Forty‐six individuals were treated more than once. Needle exchanges and community pharmacies initiated 49% of all treatments. Regression analyses implied pharmacies had superior follow‐up, but there was no difference in likelihood of achieving SVR in community pathways relative to hospital care. Re‐infection occurred 39 times over 256.57 person years (PY), yielding a rate of 15.20 per 100 PY (95% CI 10.81‐20.78). 54 deaths occurred (29 drug related) over 1,553.04 PY, yielding a mortality rate of 3.48 per 100 PY (95% CI 2.61‐4.54). Drug‐related mortality was 1.87 per 100 PY (95% CI 1.25‐2.68).ConclusionsRapid HCV treatment scale‐up to PWID in community settings, whilst maintaining high SVR, is achievable. However, other interventions are required to minimise re‐infection; reduce drug‐related deaths; and improve post‐SVR follow‐up testing regionally.

HCV communication within ego-centric networks of men and women who inject drugs

IntroductionLeveraging interpersonal communication among social networks of people who inject drugs (PWID) may be an innovative strategy to increase awareness and access to hepatitis C (HCV) care. However, little is known about HCV communication patterns among PWID and if these patterns vary by gender. MethodsEgocentric network data collected at baseline from HCV-infected PWID enrolled in a randomized HCV treatment intervention trial in Baltimore, Maryland were analyzed. Logistic generalized estimating models were conducted to identify predictors of HCV communication. ResultsAmong 227 PWID, the mean age was 43.8 (SD=10.3), 28.2% (n = 64) were women and 71.8% (n = 163) were men. Female participants reported 516 dyadic relationships and male participants 1139 dyadic relationships. While there were significant gender differences based on socio-demographics, risk behavior and network composition, there were few differences in HCV communication patterns. Both men and women had increased odds of HCV communication with alters who are currently enrolled in drug treatment (AOR 1.7, 95% CI: 1.3–2.4), alters with whom participants share drug preparation equipment (AOR 3.0, 95% CI: 1.9–4.6), alters who are sex partners compared to kin (AOR 3.0; 95% CI: 1.9–4.9) and alters with whom respondents have increased trust (AOR 1.1; 95% CI: 1.11.2) and daily/weekly interactions (AOR 1.7; 95% CI 1.3–2.1). ConclusionPWID engaged with trusted alters about HCV disclosure and information, highlighting the important role network interventions could play in this vulnerable population.

Model of Care for Microelimination of Hepatitis C Virus Infection among People Who Inject Drugs.

Background: People who inject drugs (PWID) are the largest group at risk for HCV infection. Despite the direct acting antivirals (DAA) advancements, HCV elimination has been hindered by real-life difficulties in PWID. Aims: This study aimed to assess the impact of a multidisciplinary intervention strategy where HCV screening, treatment and follow-up were performed at the same location on efficacy and safety of DAA-therapy in real-life PWID population. Methods: All HCV-infected PWID referred to five specialized outpatient centers for drug addicts (SerDs) in Northern Italy were prospectively enrolled from May 2015 to December 2019. Hepatologists and SerDs healthcare workers collaborated together in the management of PWID inside the SerDs. Sustained virologic response (SVR), safety of treatment, proportion of patients lost to follow-up and reinfection rate were evaluated. Results: A total of 358 PWID started antiviral treatment. About 50% of patients had advanced fibrosis/cirrhosis, 69% received opioid substitution treatment, and 20.7% self-reported recent injecting use. SVR was achieved in 338 (94.4%) patients. Two patients died during treatment; one prematurely discontinued, resulting in a non-responder; twelve were lost during treatment/follow-up; and five relapsed. No serious adverse events were reported. SVR was lower in recent PWID than in former ones (89.2% vs. 95.8%; p = 0.028). Seven reinfections were detected, equating to an incidence of 1.25/100 person-years. Reinfection was associated with recent drug use (OR 11.07, 95%CI 2.10–58.38; p = 0.005). Conclusion: Our embedded treatment model could be appropriate to increase the linkage to care of HCV-infected PWID. In this setting, DAA regimens are well tolerated and highly effective, achieving a lower rate of reinfection.

Utilizing patient perception of group treatment in exploring medication adherence, social support, and quality of life outcomes in people who inject drugs with hepatitis C

People who inject drugs (PWID) have a high prevalence of hepatitis C virus (HCV). Group treatment is a practical option for addressing barriers to treatment in this population. Prior research on group treatment has resulted in mixed conclusions about its effectiveness in addressing barriers to treatment. A patient's perception of the group environment may help to explain this variability. This study sought to explore the association between indicators of group treatment environment and improved outcomes in HCV-infected PWID. This secondary analysis of a randomized controlled trial exploring different models of treatment for HCV in a PWID population consisted of 42 participants randomized to the group treatment branch of the trial. Independent variables consisted of group sessions attended and group climate constructs of engagement, conflict, and avoidance. Dependent variables consisted of medication adherence, social support, and health-related quality of life. The study implemented generalized estimating equations to assess associations with the outcomes at the end of treatment. Factors indicative of group treatment environment were related to medication adherence and other barriers to health for HCV-infected PWID: social support and health-related quality of life. Perceptions of conflict or avoidance were associated with worse outcomes, while increased session attendance was generally associated with better outcomes. The study attests to the importance of examining group environment factors during treatment interventions. Although preliminary, the study provides specific indicators of treatment success for HCV-infected PWID and practical implications to improve patients' health outcomes and better tailor treatment to the patient.

Directly Acting Antiviral-Based Treatment for HCV-Infected Persons Who Inject Drugs: A Multicenter Real-Life Study.

Background: We aimed to evaluate the factors associated with a virological response in a cohort of Hepatitis C virus (HCV)-infected people who inject drugs (PWID) treated with direct acting antivirals (DAAs). Methods: We conducted a multicenter retrospective cohort study enrolling HCV-infected PWID treated with DAAs. The primary outcome evaluated was the sustained virological response (SVR12) rate. Results: Five hundred and twenty HCV-infected PWID treated with all-oral DAA-based regimens were enrolled; a total of 168 (32.3%) patients presented genotype 1a, 109 (21.0%) genotype 1b, and 174 (33.5%) genotype 3; a total 152 of the 520 subjects (29.2%) were cirrhotics; a total 118 (22.7%) and 373 (71.7%) were treated with DAA regimens of second and third generation, respectively; a total 169 (33.6%) patients were receiving an opioid agonist at the start of antiviral therapy. Only 11 subjects (2.1%) did not show an SVR12. A significant correlation was found between treatment with opioid substitution therapy (p < 0.001), Human Immunodeficiency Virus (HIV) coinfection (p = 0.002), and treatment with first- or second-generation regimens (p = 0.0015) and HCV failure. Upon multivariate analysis, treatment with a first- or second-generation DAA was the only factor independently associated with failure (OR 10.4, 95% CI: 1.43 to 76.1, p = 0.02). Conclusions: Treatment with DAAs led to a high SVR12 rate (97.9%) in a large cohort of HCV-infected PWID. The only predictor of viral failure found in our analysis was treatment with first- and second-generation DAA.

Factors and HCV treatment outcomes associated with smoking among people who inject drugs on opioid agonist treatment: secondary analysis of the PREVAIL randomized clinical trial

BackgroundCigarette smoking has emerged as a leading cause of mortality among people with hepatitis C virus (HCV). People who inject drugs (PWID) represent the largest group of adults infected with HCV in the US. However, cigarette smoking remains virtually unexplored among this population. This study aimed at (1) determining prevalence and correlates of cigarette smoking among HCV-infected PWID enrolled in opiate agonist treatment programs; (2) exploring the association of smoking with HCV treatment outcomes including adherence, treatment completion and sustained virologic response (SVR); and 3) exploring whether cigarette smoking decreased after HCV treatment.MethodsParticipants were 150 HCV-infected PWID enrolled in a randomized clinical trial primarily designed to test three intensive models of HCV care. Assessments included sociodemographics, presence of chronic health and psychiatric comorbidities, prior and current drug use, quality of life, and HCV treatment outcomes.ResultsThe majority of the patients (84%) were current cigarette smokers at baseline. There was a high prevalence of psychiatric and medical comorbidities in the overall sample of PWID. Alcohol and cocaine use were identified as correlates of cigarette smoking. Smoking status did not influence HCV treatment outcomes including adherence, treatment completion and SVR. HCV treatment was not associated with decreased cigarette smoking.ConclusionsThe present study showed high prevalence of cigarette smoking among this population as well as identified correlates of smoking, namely alcohol and cocaine use. Cigarette smoking was not associated with HCV treatment outcomes. Given the detrimental effects that cigarette smoking and other co-occurring, substance use behaviors have on HCV-infected individuals’ health, it is imperative that clinicians treating HCV also target smoking, especially among PWID. The high prevalence of cigarette smoking among PWID will contribute to growing morbidity and mortality among this population even if cured of HCV. Tailored smoking cessation interventions for PWID along with HCV treatment may need to be put into clinical practice.Trial registrationNCT01857245. Registered May 20, 2013.

Declines in Depressive Symptoms Among People who Inject Drugs Treated With Direct-Acting Antivirals While on Opioid Agonist Therapy.

BackgroundHepatitis C virus (HCV) frequently co-occurs with symptoms of depression, which are aggravated on interferon-based regimens. However, it is unknown whether HCV treatment with direct-acting antivirals (DAAs) has effects on depressive symptoms among people who inject drugs (PWID). In this study, we examined changes in depressive symptoms during and after HCV treatment among PWID on opioid agonist therapies (OATs).MethodsParticipants were 141 PWID who achieved sustained viral response after on-site HCV treatment at 3 OAT programs.Depressive symptoms were assessed using the Beck Depression Inventory–II (BDI-II) at baseline, every 4 weeks during treatment, and 12 and 24 weeks after treatment completion. Current diagnosis of depression or other psychiatric diagnoses were obtained through chart review. Use of illicit drugs was measured by urine toxicology screening. Alcohol use was measured using the Addiction Severity Index–Lite.ResultsOf the 141 PWID infected with HCV, 24.1% had severe, 9.9% had moderate, 15.6% had mild, and 50.4% had minimal levels of depression as per BDI-II scores at baseline. HCV treatment was significantly associated with reductions in depressive symptoms that persisted long term, regardless of symptom severity (P < .001) or presence of depression (P ≤ .01) or other psychiatric diagnoses (P ≤ .01) at baseline. Concurrent drug use (P ≤ .001) or hazardous alcohol drinking (P ≤ .001) did not interfere with reductions in depressive symptoms.ConclusionsDepressive symptoms are highly prevalent among HCV-infected PWID. HCV treatment was associated with sustained reductions in depressive symptoms. HCV therapy with DAAs may have important implications for PWID that go beyond HCV cure.

Individual and network factors associated with HCV treatment uptake among people who inject drugs

BackgroundHepatitis C virus (HCV) treatment uptake among people who inject drugs (PWID), a population with disproportionately high rates of HCV, remains low. Peers have been shown to positively impact a broad range of health outcomes for PWID. There is, however, limited data on the impact of PWID social network members on HCV treatment. MethodsHCV-infected PWID enrolled in an ongoing community-based cohort were recruited as “indexes” to complete an egocentric social network survey. The survey elicited from the index PWID a list of their network members and the index's perception of network member characteristics. Logistic regression analyses were conducted to compare individual and network factors associated with HCV treatment in the index PWID. ResultsAmong 540 HCV-infected PWID, the mean age was 55.7 years and the majority were black (87.2%) and male (69.8%). PWID reported a mean of 4.4 (standard deviation [SD] 3.2) network members, most of whom were relatives (mean 2.2 [SD 1.5]). In multivariable analysis, increasing index age and HIV infection were positively associated with HCV treatment, while drug use and homelessness in the preceding 6 months were negatively associated with HCV treatment. From a network perspective, having at least one network member who regularly talked with the index about seeing their doctor for HIV care was associated with HCV treatment (Adjusted Odds Ratio [AOR] 2.7; 95% Confidence Interval (CI) [1.3, 5.6]). Conversely, PWID who had at least one network member who helped them understand their HCV care were less likely to have been HCV treated (AOR 0.2; CI [0.1, 0.6). ConclusionHCV treatment uptake in this group of PWID appeared to be positively influenced by discussions with network members living with HIV who were in care and negatively influenced by HCV information sharing within PWID networks. These findings underscore the influence of peers on health seeking behaviors of their network members and emphasizes the importance of well-informed peers.

Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study

BackgroundAlthough people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models – patient navigation (PN) or modified directly observed therapy (mDOT) – results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection. MethodsThe HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT. ConclusionsThis study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.

Scaling Up Hepatitis C Prevention and Treatment Interventions for Achieving Elimination in the United States: A Rural and Urban Comparison.

In the United States, hepatitis C virus (HCV) transmission is rising among people who inject drugs (PWID). Many regions have insufficient prevention intervention coverage. Using modeling, we investigated the impact of scaling up prevention and treatment interventions on HCV transmission among PWID in Perry County, Kentucky, and San Francisco, California, where HCV seroprevalence among PWID is >50%. A greater proportion of PWID access medication-assisted treatment (MAT) or syringe service programs (SSP) in urban San Francisco (established community) than in rural Perry County (young, expanding community). We modeled the proportion of HCV-infected PWID needing HCV treatment annually to reduce HCV incidence by 90% by 2030, with and without MAT scale-up (50% coverage, both settings) and SSP scale-up (Perry County only) from 2017. With current MAT and SSP coverage during 2017-2030, HCV incidence would increase in Perry County (from 21.3 to 22.6 per 100 person-years) and decrease in San Francisco (from 12.9 to 11.9 per 100 person-years). With concurrent MAT and SSP scale-up, 5% per year of HCV-infected PWID would need HCV treatment in Perry County to achieve incidence targets-13% per year without MAT and SSP scale-up. In San Francisco, a similar proportion would need HCV treatment (10% per year) irrespective of MAT scale-up. Reaching the same impact by 2025 would require increases in treatment rates of 45%-82%. Achievable provision of HCV treatment, alongside MAT and SSP scale-up (Perry County) and MAT scale-up (San Francisco), could reduce HCV incidence.

Response to direct-acting antiviral therapy among ongoing drug users and people receiving opioid substitution therapy

People who inject drugs (PWID) and are on opioid agonist therapy (OAT) might have lower adherence to direct-acting antivirals (DAAs) against hepatitis C virus (HCV) and, therefore, lower rates of sustained virologic response (SVR). Because of this, we compared the SVR rates to interferon-free DAA combinations in individuals receiving OAT and those not receiving OAT in a real-world setting. The HEPAVIR-DAA cohort, recruiting HIV/HCV-coinfected patients (NCT02057003), and the GEHEP-MONO cohort (NCT02333292), including HCV-monoinfected individuals, are ongoing prospective multicenter cohorts of patients receiving DAAs in clinical practice. We compared SVR 12 weeks after treatment (SVR12) in non-drug users and PWID, including those receiving or not receiving OAT. Intention-to-treat and per protocol analyses were performed. Overall, 1,752 patients started interferon-free DAA treatment. By intention-to-treat analysis, 778 (95%, 95% CI 93%-96%) never injectors, 673 (92%, 95% CI 89%-93%) PWID not on OAT and 177 (89%, 95% CI 83%-92%) PWID on OAT achieved SVR12 (p = 0.002). SVR12 rates for ongoing drug users (with or without OAT) were 68 (79%) compared with 1,548 (95%) for non-drug users (p <0.001). Among ongoing drug users, 15 (17%) were lost-to-follow-up, and 3 (3.5%) became reinfected. In the per protocol analysis, 97% never injectors, 95% PWID not on OAT and 95% PWID on OAT achieved SVR12 (p = 0.246). After adjustment, ongoing drug use was associated with SVR12 (intention-to-treat) and OAT use was not. HCV-infected PWID achieve high SVR12 rates with DAAs whether they are on OAT or not, but their response rates are lower than those of patients who never used drugs. This is mainly attributable to more frequent loss to follow-up. Accounting for active drug use during DAA therapy nearly closed the gap in SVR rates between the study groups. Patients with hepatitis C virus infection who are on opioid agonist therapy can achieve high cure rates with current treatments. The use of illicit drugs during treatment can drive drop-outs and reduce cure rates. However, hepatitis C can be cured in most of those using drugs who complete treatment and follow-up. Clinical trial number: HEPAVIR-DAA cohort, NCT02057003; GEHEP-MONO cohort, NCT02333292.

Barriers and facilitators of hepatitis C treatment uptake among people who inject drugs enrolled in opioid treatment programs in Baltimore

BackgroundHepatitis C virus (HCV) infection is a major public health issue among people who inject drugs (PWID) with prevalence of 50–80% in the United States. Effective, simple, oral direct acting agents (DAA) of short duration with minimal side effects have been associated with cure rates > 95%. However, HCV treatment uptake among PWID remains low. We characterized the HCV care continuum, HCV treatment knowledge, as well as barriers and facilitators to HCV treatment uptake among PWID enrolled in two opioid treatment programs (OTPs) in Baltimore, Maryland, USA. MethodsBetween July and November 2016, 124 HCV infected PWID were recruited from two opioid treatment programs in Baltimore through convenience sampling. Participants completed a 50-item questionnaire to assess HCV treatment knowledge, attitudes, and practices. Progress through the HCV care continuum was assessed based on a series of questions assessing evaluation for HCV treatment, recommendation for HCV treatment by a provider, and HCV treatment initiation. HCV status was assessed based on participant self-report. ResultsThe median age was 52 years (IQR 44–58), 56% were male, the majority were African American (69%), and 19% reported HIV coinfection. Participants had been tested for HCV at their primary care provider's (PCP's) office (34%), drug treatment center (20%), emergency room (11%), or prison (9%), and most (60%) had been diagnosed with HCV over 5 years prior. The majority reported that HCV was a major health concern for them (91%), were aware there were new treatments for HCV (89%), and that the new treatments cure most people (69%). More than half (60%) had seen a health professional who could treat HCV, 40% had HCV therapy recommended by their HCV specialist, and 20% had started or completed treatment. In univariable analysis, PWID were significantly more likely to have been treated if they were HIV co-infected (OR 3.4 (95% CI 1.3–9.2)) or had a partner or friend concerned about their HCV (OR 3.4 (95% CI 1.2–9.7)), and were significantly less likely to have been treated if they had used any illicit drugs in the preceding 6 months (OR 0.4 (95% CI 0.2–0.99). In multivariable analysis, having a friend or partner concerned about their HCV remained significantly associated with HCV treatment (OR 5.0 (95% CI 1.4–17.7)). When questioned about what would facilitate HCV treatment, the majority (85%) reported that a friend telling them that HCV treatment had helped them and having HCV treatment provided at their opioid treatment program would make them more likely to engage in HCV treatment. ConclusionDespite a high prevalence of HCV among opioid treatment program patients and the availability of effective treatments, uptake remains low. We identified several key barriers and facilitators that can affect HCV treatment uptake.

2216. Hepatitis C Treatment Wanted Yet Not Received: Barriers to Receiving HCV Treatment Among People Who Inject Drugs

BackgroundTo expand hepatitis C (HCV) treatment for people who inject drugs (PWID), programs need to overcome barriers to initiating treatment. We asked HCV-infected PWID about past experiences with HCV care.MethodsThese data are collected from the first 44 participants enrolled in an ongoing study of HCV care for PWID delivered at a syringe services program in New York City. Eligible participants were HCV RNA positive and had injected drugs in the past 90 days. We used a structured interview to ask about prior linkage to HCV treatment and the reasons for not obtaining treatment.ResultsAmong the 44 participants, mean age is 40 years; 73% are males; 48% Hispanic, 38% non-Hispanic white; 7% non-Hispanic black and 7% mixed-race or other. Almost all (96%) had health insurance, with 86% having public insurance (Medicaid). Most participants (91%) were aware of their HCV diagnosis before enrollment. All wanted to be treated for HCV, and 88% wanted treatment to prevent infecting others. 48% had previously been referred for HCV treatment, only 21% had been offered treatment, and none had started. When asked about barriers to treatment, 56% participants felt that they would need to stop using drugs to get HCV treatment, 61% felt that HCV treatment had many side effects and 20% reported insurance coverage barriers.ConclusionAmong PWID enrolled at a syringe services program, all wanted HCV treatment; most to prevent infecting others. Despite high rates of insurance coverage and desire to be treated, most participants have neither been referred to HCV care nor offered treatment. Many participants also had misconceptions about HCV treatment eligibility and side effects. Providing HCV care and education in a low-threshold model, such as walk-in visits at community sites, may help alleviate these barriers.Disclosures S. Kapadia, Gilead Sciences Inc.: Grant Investigator, Research grant. B. Eckhardt, Gilead Sciences Inc.: Grant Investigator, Research grant. K. M. Marks, Gilead Sciences Inc.: Grant Investigator, Research grant; Merck: Grant Investigator, Research grant; Bristol-Meyers Squibb: Grant Investigator, Research grant.

Commentary on Grebely et al. (2019): Ending HCV epidemics among people who inject drugs.

The new direct-acting antiretroviral drugs for treating hepatitis C have generated considerable momentum for treating HCV infection among people who inject drugs and perhaps ‘ending the HCV epidemic’. There are, however, important epidemiological and behavior research problems that need to be addressed before ‘ending the HCV epidemic’ will be possible. The development of direct-acting antivirals (DAAs) that cure HCV infection in more than 90% of patients with minimal side effects has led to calls for ‘eliminating HCV infection’ or ‘ending HCV epidemics’ among people who inject drugs (PWID) 1. Some of the calls for eliminating HCV infection have included substantial allocations of new funds, e.g. New York State 2. Grebely et al. 3 have estimated the number and prevalence of people with a recent history (within past year) of injecting drug use who are living with hepatitis C virus (HCV) viremia and the proportion of people with recent injecting drug use among all people living with HCV infection at the global, regional and national levels. A major value of this study is its potential contribution as a baseline for ‘eliminating HCV’. While DAAs and the lessons from successfully controlling HIV among PWID in many areas 4 should certainly be useful in controlling HCV among PWID, the data presented in Grebely et al. illustrate that there is still a major amount of epidemiological and behavioral science that will be needed before ‘eliminating’ (or even ‘controlling’) HCV among PWID can be accomplished. First, what would ‘elimination/ending the epidemic’ of HCV among PWID look like? From early in the HIV epidemic among PWID, we had multiple examples, e.g. Glasgow, Scotland, Lund, Sweden, Sydney, Australia and Tacoma, WA, USA, where large-scale implementation of syringe access programs have kept HIV prevalence stable at less than 5% 5. The Grebely et al. data do not provide many (if any) examples of areas where HCV viremia has been stabilized at ‘ending the epidemic’ levels. Would 5% viremia in the local PWID population be a realistic goal? What sort of HCV combined prevention and care programs would be needed to stabilize HCV at 5% or less in a PWID population? Such a system would need to detect and treat existing cases of HCV infection as rapidly as new infections were occurring. Secondly, how will we develop better estimates of the size of PWID populations and the percentage of PWID who are HCV viremic? The uncertainty intervals in the Grebely et al. estimates are rather large, typically almost as large as the estimates themselves. Uncertainty in the estimates of the PWID population size and the percentage of PWID who are HCV viremic would create difficult problems for local officials who would have the task of allocating resources and planning logistical operations for rapidly scaling-up treatment for HCV-infected PWID. Thirdly, what new interventions can be developed to reduce HCV transmission behavior among viremic PWID? One of the important factors in HIV prevention was that PWID who learned that they were HIV-seropositive greatly reduced transmission behavior (passing their used needles and syringes to others) well before antiretroviral therapy (ART) was available 6. We have not yet seen the equivalent reductions in transmission behaviors among PWID who know that they are HCV-seropositive 7. How do we successfully encourage HCV viremic PWID to reduce transmission behavior? Fourthly, what interventions can be developed and implemented to reduce the very high HCV incidence rates among people who have recently begun injecting drugs 8? Many new injectors typically do not identify as ‘drug injectors’, and thus do not utilize HIV/HCV safer injection programs 9. Fifthly, what interventions will be implemented to reduce the rates that drug users transition to injecting drug use? There have been calls for more research on this topic 10, and there are current research studies addressing this subject. However, the objective should be to develop an evidence base for reducing initiation into injecting drug use that is comparable to the evidence base for medication assisted treatment and for syringe access programs. The new DAAs certainly give us the capability of treating very large numbers of HCV infected people who use drugs and greatly reduce morbidity and mortality, and programs to provide access to HCV treatment should be scaled-up in high-, middle- and low-income countries as quickly as feasible, and the additional research needed to learn how to ‘end HCV epidemics’ among PWID should be funded. Finally, and perhaps most importantly, while the above may be considered scientific tasks, it is important to emphasize that the research should be conducted in full collaboration with PWID and drug-user organizations. Such collaboration should not only greatly improve the quality of the research, but also greatly improve the likelihood that the findings will be incorporated into public health programs that could ‘end the HCV epidemic’ among people who use drugs. None.

Hepatitis C virus prevention and care for drug injectors: the French approach

After France removed hepatitis C treatment reimbursement restrictions on 25 May 2016, an expert report presented recommendations, which focused on vulnerable groups including people who inject drugs (PWID). This commentary presents the key points of the chapter with a particular focus on policy.Thanks to the official lifting of restrictions based on disease stage and to the excellent efficacy and tolerance of the new DAA (Direct-Acting Antivirals) among PWID, the main issue is to improve the HCV care cascade. In France, many HCV-infected PWID, especially active/current PWID, remain undiagnosed and unlinked to care. Our challenge is to improve HCV screening by point of care testing (POCT), outreach methods with mobile teams, rapid tests, FibroScan, etc. and to provide PWID with appropriate services in all the settings they attend, such as drug treatment or harm reduction services, social services, prisons, etc. Another important issue is the prevention of reinfection through comprehensive and long-term follow-up.The report recommends a new national policy: testing and treating PWID as a priority, since this is the best way to eliminate HCV infection. It requires a global strategy consisting of combined and long-term interventions: prevention, outreach, screening, DAA, drug treatment programs including opiate substitution treatment (OST) and various harm reduction programs, including needle exchange programs (NEP). Ideally, these services should be delivered in the same place with an integrated approach. This should lead to meeting the national objective set by the government of eliminating hepatitis C by 2025.

Real-world Efficacy of Direct-Acting Antiviral Therapy for HCV Infection Affecting People Who Inject Drugs Delivered in a Multidisciplinary Setting.

BackgroundMany clinicians and insurance providers are reluctant to embrace recent guidelines identifying people who inject drugs (PWID) as a priority population to receive hepatitis C virus (HCV) treatment. The aim of this study was to evaluate the efficacy of direct-acting antiviral (DAA) HCV therapy in a real-world population comprised predominantly of PWID.MethodsA retrospective analysis was performed on all HCV-infected patients who were treated at the Vancouver Infectious Diseases Centre between March 2014 and December 2017. All subjects were enrolled in a multidisciplinary model of care, addressing medical, psychological, social, and addiction-related needs. The primary outcome was achievement of sustained virologic response (undetectable HCV RNA) 12 or more weeks after completion of HCV therapy (SVR-12).ResultsOverall, 291 individuals were enrolled and received interferon-free DAA HCV therapy. The mean age was 54 years, 88% were PWID, and 20% were HCV treatment experienced. At data lock, 62 individuals were still on treatment and 229 were eligible for evaluation of SVR by intent-to-treat (ITT) analysis. Overall, 207 individuals achieved SVR (90%), with 13 losses to follow-up, 7 relapses, and 2 premature treatment discontinuations. ITT SVR analysis show that active PWID and treatment-naïve patients were less likely to achieve SVR (P = .0185 and .0317, respectively). Modified ITT analysis of active PWID showed no difference in achieving SVR (P = .1157) compared with non-PWID.ConclusionWithin a multidisciplinary model of care, the treatment of HCV-infected PWID with all-oral DAA regimens is safe and highly effective. These data justify targeted efforts to enhance access to HCV treatment in this vulnerable and marginalized population.

Respondent-driven sampling for identification of HIV- and HCV-infected people who inject drugs and men who have sex with men in India: A cross-sectional, community-based analysis.

BackgroundA major barrier to achieving ambitious targets for global control of HIV and hepatitis C virus (HCV) is low levels of awareness of infection among key populations such as men who have sex with men (MSM) and people who inject drugs (PWID). We explored the potential of a strategy routinely used for surveillance in these groups, respondent-driven sampling (RDS), to be used as an intervention to identify HIV- and HCV-infected PWID and MSM who are unaware of their status and those who are viremic across 26 Indian cities at various epidemic stages.Methods and findingsData were collected as part of the baseline assessment of an ongoing cluster-randomized trial. RDS was used to accrue participants at 27 sites (15 PWID sites and 12 MSM sites) selected to reflect varying stages of the HIV epidemic among MSM and PWID in India. A total of 56 seeds recruited a sample of 26,447 persons (approximately 1,000 participants per site) between October 1, 2012, and December 19, 2013. Across MSM sites (n = 11,997), the median age was 25 years and the median number of lifetime male partners was 8. Across PWID sites (n = 14,450), 92.4% were male, the median age was 30 years, and 87.5% reported injection in the prior 6 months. RDS identified 4,051 HIV-infected persons, of whom 2,325 (57.4%) were unaware of their HIV infection and 2,816 (69.5%) were HIV viremic. It also identified 5,777 HCV-infected persons, of whom 5,337 (92.4%) were unaware that they were infected with HCV and 4,728 (81.8%) were viremic. In the overall sample (both MSM and PWID), the prevalence of HIV-infected persons who were unaware of their status increased with sampling depth, from 7.9% in participants recruited in waves 1 through 5 to 12.8% among those recruited in waves 26 and above (p-value for trend < 0.001). The overall detection rate of people unaware of their HIV infection was 0.5 persons per day, and the detection rate of HIV-infected persons with viremia (regardless of their awareness status) was 0.7 per day. The detection rate of HIV viremic individuals was positively associated with underlying HIV prevalence and the prevalence of HIV viremia (linear regression coefficient per 1-percentage-point increase in prevalence: 0.05 and 0.07, respectively). The median detection rate of PWID who were unaware of their HCV infection was 2.5 per day. The cost of identifying 1 unaware HIV-infected individual ranged from US$51 to US$2,072 across PWID sites and from US$189 to US$5,367 across MSM sites. The mean additional cost of identifying 1 unaware HCV-infected PWID was US$13 (site range: US$7–US$140). Limitations of the study include the exclusivity of study sites to India, lack of prior HIV/HCV diagnosis confirmation with clinic records, and lack of cost data from other case-finding approaches commonly used in India.ConclusionsIn this study, RDS was able to rapidly identify at nominal cost a substantial number of unaware and viremic HIV-infected and HCV-infected individuals who were currently not being reached by existing programs and who were at high risk for transmission. Combining RDS (or other network-driven recruitment approaches) with strategies focused on linkage to care, particularly in high-burden settings, may be a viable option for achieving the 90-90-90 targets in key populations in resource-limited settings.