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The World Health Organization (WHO) has targeted eliminating viral hepatitis as a public health problem by 2030. Thus, high-risk groups such as Methadone Maintenance Therapy (MMT) clients should be targeted for hepatitis C health intervention to increase intention for hepatitis C infection treatment. This study aims to evaluate the effectiveness of theory-based hepatitis C health education and learning module (HEAL) in increasing intention to participate in hepatitis C treatment among MMT clients in Malacca. A single-blinded cluster randomised control trial was conducted among selected MMT clients from government health clinics in Malacca from July 2023 to February 2024. The clinics involved was randomly allocated into intervention and control groups. The intervention group received HEAL module developed based on the Theory of Planned Behavioural while the control group attended clinic session as usual. Generalized Estimating Equation (GEE) analysis was used for statistical analysis. GEE shows that there is significant interaction between time and group for both intention for hepatitis C treatment and knowledge on hepatitis C. Intervention group at immediately post intervention follow up had higher intention for hepatitis C treatment as compared to control group (β = 0.56, 95% CI = 0.12, 1.01, p-value < 0.01). However, there were no significant different in intention for hepatitis C treatment between the two group at 3-month post intervention follow up. Furthermore, intervention group had significant higher knowledge at immediately post intervention (β = 8.85, 95% CI = 7.35, 10.36, p-value < 0.001) and at 3-month post intervention (β = 5.25, 95% CI = 3.76, 6.75, p-value < 0.001) as compared to the control group. However, the knowledge level among the intervention group reduces at 3-month post intervention follow up as compared to knowledge level at immediately post intervention follow up. HEAL module which utilizes motion video and group discussion was effective in increasing MMT client's intention for hepatitis C treatment and knowledge about hepatitis C. However, future research should focus on finding effective strategies to ensure retention of the outcomes of HEAL module intervention over time.

Abstract Background To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to direct-acting antivirals (DAAs), especially among people who inject drugs (PWID). We aimed to determine the effectiveness of providing DAAs in primary care, compared with hospital-based specialist care. Methods We randomized PWID with HCV attending primary care sites in Australia or New Zealand to receive DAAs at their primary care site or local hospital (standard of care [SOC]). The primary outcome was to determine whether people treated in primary care had a noninferior rate of sustained virologic response at Week 12 (SVR12), compared to historical controls (consistent with DAA trials at the time of the study design); secondary outcomes included comparisons of treatment initiation, SVR12 rates, and the care cascade by study arm. Results We recruited 140 participants and randomized 136: 70 to the primary care arm and 66 to the SOC arm. The SVR12 rate (100%, 95% confidence interval [CI] 87.7–100) of people treated in primary care was noninferior when compared to historical controls (85% assumed). An intention-to-treat analysis revealed that the proportion of participants commencing treatment in the primary care arm (75%, 43/57) was significantly higher than in the SOC arm (34%, 18/53; P < .001; relative risk [RR] 2.48, 95% CI 1.54–3.95), and the proportion of participants with SVR12 was significantly higher in the primary care arm, compared to in the SOC arm (49% [28/57] and 30% [16/53], respectively; P = .043; RR 1.63, 95% CI 1.0–2.65). Conclusions Providing HCV treatment in primary care increases treatment uptake and cure rates. Approaches that increase treatment uptake among PWID will accelerate elimination strategies. Clinical Trials Registration NCT02555475. Providing direct-acting antivirals for hepatitis C virus in primary care significantly increases treatment uptake and cure rates in people who inject drugs, compared to referral to hospital-based services. Hepatitis C treatment should be available in primary care.

AbstractObjectivesTo quantify mortality rates for patients successfully treated for hepatitis C in the era of interferon-free, direct acting antivirals and compare these rates with those of the general population.DesignPopulation based cohort study.SettingBritish Columbia, Scotland, and England (England cohort consists of patients with cirrhosis only).Participants21 790 people who were successfully treated for hepatitis C in the era of interferon-free antivirals (2014-19). Participants were divided into three liver disease severity groups: people without cirrhosis (pre-cirrhosis), those with compensated cirrhosis, and those with end stage liver disease. Follow-up started 12 weeks after antiviral treatment completion and ended on date of death or 31 December 2019.Main outcome measuresCrude and age-sex standardised mortality rates, and standardised mortality ratio comparing the number of deaths with that of the general population, adjusting for age, sex, and year. Poisson regression was used to identify factors associated with all cause mortality rates.Results1572 (7%) participants died during follow-up. The leading causes of death were drug related mortality (n=383, 24%), liver failure (n=286, 18%), and liver cancer (n=250, 16%). Crude all cause mortality rates (deaths per 1000 person years) were 31.4 (95% confidence interval 29.3 to 33.7), 22.7 (20.7 to 25.0), and 39.6 (35.4 to 44.3) for cohorts from British Columbia, Scotland, and England, respectively. All cause mortality was considerably higher than the rate for the general population across all disease severity groups and settings; for example, all cause mortality was three times higher among people without cirrhosis in British Columbia (standardised mortality ratio 2.96, 95% confidence interval 2.71 to 3.23; P<0.001) and more than 10 times higher for patients with end stage liver disease in British Columbia (13.61, 11.94 to 15.49; P<0.001). In regression analyses, older age, recent substance misuse, alcohol misuse, and comorbidities were associated with higher mortality rates.ConclusionMortality rates among people successfully treated for hepatitis C in the era of interferon-free, direct acting antivirals are high compared with the general population. Drug and liver related causes of death were the main drivers of excess mortality. These findings highlight the need for continued support and follow-up after successful treatment for hepatitis C to maximise the impact of direct acting antivirals.

Background Facilitated telemedicine is highly effective for hepatitis C virus (HCV) treatment among people with opioid use disorder (OUD). However, the long‐term impact of sustained virological response (SVR) through this model of treatment remains unexplored. We examined how people with OUD perceive SVR achieved through facilitated telemedicine. Methods We conducted two focus group discussions (FGDs) with nine participants at least 5 years post‐SVR through a randomised controlled trial of facilitated telemedicine in opioid treatment programmes (OTPs) (New York State, 2018–2020). Eligibility required active OTP enrolment at the time of FGDs. We used a semi‐structured interview guide and performed thematic analysis of FGD transcripts. Results Participants had a mean age of 52.6 years (SD = 13.7), 66.6% were male, and 88.8% identified as White. We identified three FGD themes, each corresponding to pre‐, during and post‐intervention phases (see Figure 1): (1) Attitudes towards HCV and barriers to treatment among people with OUD, (2) Embracing facilitated telemedicine for HCV care integrated into OTPs, and (3) Experiencing long‐term benefits from facilitated telemedicine across all aspects of HCV care and overall well‐being. Barriers included competing priorities, perceiving HCV treatment as a low priority, and insurance restrictions (Theme 1). Participants valued facilitated telemedicine for its convenience, empathetic clinicians, and one‐stop shop approach (Theme 2). At least 5 years post‐SVR, participants reported benefits in HCV knowledge, improved OUD recovery, and improvement in whole health (Theme 3). Conclusion At least 5 years post‐SVR, people with OUD reported improvements in OUD recovery, overall well‐being and sustained satisfaction with telemedicine‐based HCV care. These findings highlight the lasting impact of both an SVR and care delivery through facilitated telemedicine. Patient and Public Contribution In this study of patient involvement, we conducted focus groups with patient‐participants to examine the long‐term impact of receiving HCV care through facilitated telemedicine integrated into OTPs. Participants had previously taken part in a randomised controlled trial of facilitated telemedicine (New York State, 2018–2020). At least 5 years after achieving an SVR, we sought participant feedback to evaluate the long‐term impact and sustainability of facilitated telemedicine as an approach to achieve an HCV cure with the objective of informing future policy development. Participants had also contributed critical input at various stages of the original study's design and implementation. During the pilot phase, participants advocated for facilitated telemedicine in a testimonial video. Participants provided feedback on design and implementation by participating in planning and site initiation meetings. A Patient Advisory Committee ensured participant voices were integrated into the research process by representing their feedback on study conduct. Additionally, a Sustainability Committee supported public involvement by promoting educational opportunities, providing input on implementation, and addressing long‐term sustainability considerations.

Background Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors. Methods The You’re Empowered for Treatment Initiation (YETI) Partner trial is a single-site randomized controlled trial evaluating the efficacy of a two-session behavioral intervention that engages injecting partners as peer navigators for HCV treatment. We aim to recruit 250 PWID and their primary injecting partners in San Francisco, California, randomizing them 1:1 to either a control or intervention group. The primary outcome is the initiation of HCV treatment, with secondary outcomes including treatment completion and sustained virologic response 12 weeks post-treatment. Data will be collected through questionnaires and electronic health records and analyzed using intention-to-treat and mixed-effects models. Discussion This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment. If successful, the intervention could inform public health strategies and policies to address HCV in marginalized populations. Trial registration ClinicalTrials.gov NCT06179498. Registered on December 22, 2023.

People with substance use disorders (SUD) have a high prevalence of chronic hepatitis C virus (HCV) infection and mental health disorders. We aimed to assess the impact of integrated HCV treatment on psychological distress measured by Hopkins-symptom-checklist-10 (SCL-10). This multi-center randomized controlled trial evaluated psychological distress as a secondary outcome of integrated HCV treatment (INTRO-HCV trial). From 2017 to 2019, 289 participants were randomly assigned to receive either integrated or standard HCV treatment with direct-acting antiviral therapy. Integrated HCV treatment was delivered in eight decentralized outpatient opioid agonist therapy clinics and two community care centers; standard treatment was delivered in internal medicine outpatient clinics at centralized hospitals. Participants in the integrated treatment arm had a sustained virologic response of 93% compared to 73% for those in standard treatment arm. Psychological distress was assessed using SCL-10 prior to initiation of HCV treatment and 12 weeks after treatment completion. The mean SCL-10 score prior to HCV treatment was 2.2 (standard deviation [SD]: 0.7) for patients receiving integrated HCV treatment and 2.2 (SD: 0.8) for those receiving standard HCV treatment. Twelve weeks after the end of treatment, the mean SCL-10 score change was − 0.1 (− 0.3;0.0) in the integrated compared to the standard arm. Psychological distress did not substantially change during the treatment period and was not significantly different between the treatment arms.

Background As many as 2.4 million Americans are affected by chronic Hepatitis C Virus (HCV) in the United States.In 2018, the estimated number of adults with a history of HCV infection in San Diego County was 55,354 (95% CI: 25,411–93,329). This corresponded to a seroprevalence of 2.1% (95% CI: 2.1–3.4%). One-third of infections were among PWID. Published research has demonstrated that direct-acting antivirals (DAAs) have high efficacy and can now be used by primary care providers to treat HCV. In addition, limited evidence exists to support the effectiveness of simplified algorithms in clinical trial and real-world settings. Even with expanded access to HCV treatment in primary care settings, there are still groups, especially people who inject drugs (PWID) and people experiencing homelessness, who experience treatment disparities due to access and treatment barriers. The current study extends the simplified algorithm with a streetside ‘one-stop-shop’ approach with integrated care (including the offer of buprenorphine prescriptions and abscess care) using a mobile clinic situated adjacent to a syringe service program serving many homeless populations. Rates of HCV treatment initiation and retention will be compared between patients offered HCV care in a mobile clinic adjacent to a syringe services program (SSP) and homeless encampment versus those who are linked to a community clinic’s current practice of usual care, which includes comprehensive patient navigation. Methods A quasi-experimental, prospective, interventional, comparative effectiveness trial with allocation of approximately 200 patients who inject drugs and have chronic HCV to the \"simplified care\" pathway (intervention group) or the \"usual care\" pathway (control group). Block randomization will be performed with a 1:1 randomization. Discussion Previous research has demonstrated acceptable outcomes for patients treated using simplified algorithms for DAAs and point-of-care testing in mobile medical clinics; however, there are opportunities to explore how these new, innovative systems of care impact treatment initiation rates or other HCV care cascade outcomes among PWID. Trial registration We have registered our study with ClinicalTrials.gov, a resource of the United States National Library of Medicine. This database contains research studies from United States and other countries around the world. Our study has not been previously published. The ClinicalTrials.gov registration identifier is NCT04741750.

Hepatitis C virus (HCV) is a common cause of liver cirrhosis and hepatocellular carcinoma. Globally, nearly 71 million people have chronic HCV infection, and approximately 399,000 dies annually. In patients without cirrhosis, HCV infection is treated with 12 weeks of sofosbuvir/velpatasvir combination. Results from available small, single-centre observational studies suggest that the sofosbuvir/velpatasvir combination given for 8 weeks may be as effective as the standard 12 weeks of treatment. We propose to compare the treatment response of 12 weeks versus 8 weeks of sofosbuvir/velpatasvir in non-cirrhotic people with chronic HCV infection. This multicentric, randomized, open-label, non-inferiority trial will include 880 (2 arms x 440) treatment naïve, viraemic (HCV RNA >10,000 IU/mL), non-cirrhotic adults (age >18 years) with chronic hepatitis C. People who are at high-risk for HCV reinfection such as haemophiliacs, people who inject drugs, those on maintenance hemodialysis or having HIV will be excluded. The presence or absence of cirrhosis will be determined with a combination of history, examination, ultrasound, liver stiffness measured with transient elastography, APRI, FIB-4, and esophagogastroduodenoscopy. Participants will be randomized to receive either 8- or 12-week sofosbuvir/velpatasvir treatment. A blood specimen will be collected before starting the treatment (to determine the HCV genotype), after 4 weeks of treatment (for early virological response), and at 12 weeks after treatment discontinuation for SVR12. The study will provide data on the efficacy of 8 weeks of treatment as compared to the standard of care (12 weeks) in non-cirrhotic patients with chronic HCV infection. Treatment for a shorter duration may improve treatment compliance, reduce the cost of treatment, and ease the treatment implementation from a public health perspective. Registered with Clinical Trial Registry of India (http://ctri.nic.in) Registration No. CTRI/2022/03/041368 [Registered on: 24/03/2022]-Trial Registered Prospectively.

Objectives Chronic hepatitis C virus (HCV) infection is one of the main causes of hepatocellular carcinoma. Before initiating a multilevel HCV screening intervention, we sought to (1) describe concordance between the electronic health record (EHR) data warehouse and manual medical record review in recording aspects of HCV testing and treatment and (2) estimate the percentage of patients with chronic HCV infection who initiated and completed HCV treatment using manual medical record review. Methods We examined the medical records for 177 patients (100 randomly selected patients born during 1945-1965 without evidence of HCV testing and 77 adult patients of any birth cohort who had completed HCV testing) with a primary care or relevant specialist visit at an academic health care system in Tampa, Florida, from 2015 through 2018. We used the Cohen κ coefficient to examine the degree of concordance between the searchable data warehouse and the medical record review abstractions. Descriptive statistics characterized referral to and receipt of treatment among patients with chronic HCV infection from medical record review. Results We found generally good concordance between the data warehouse abstraction and medical record review for HCV testing data (κ ranged from 0.66 to 0.87). However, the data warehouse failed to capture data on HCV treatment variables. According to medical record review, 28 patients had chronic HCV infection; 16 patients were prescribed treatment, 14 initiated treatment, and 9 achieved and had a reported posttreatment undetected HCV viral load. Conclusions Using data warehouse data provides generally reliable HCV testing information. However, without the use of natural language processing and purposeful EHR design, manual medical record reviews will likely be required to characterize treatment initiation and completion.

Background The increase in opioid use disorder among young, nonurban people has fueled sharp rises in hepatitis C virus (HCV) infections. Innovative treatment models are needed that circumvent healthcare system barriers for people who use drugs (PWUD), particularly in rural areas. The Oregon HOPE TeleHCV study randomized PWUD living with HCV in rural Oregon to peer-facilitated and streamlined telemedicine HCV treatment (Peer TeleHCV) versus enhanced usual care (EUC) and assessed sustained virologic response at 12 weeks post treatment (SVR12). Peer Support Specialists (peers) conducted HCV screening in the community, facilitated pretreatment evaluation and linkage to telemedicine HCV treatment clinicians, and supported Peer TeleHCV study participants in HCV medication adherence. A qualitative investigation queried telemedicine clinicians and peers about their experiences with the implementation of the model and key drivers of implementation effectiveness. Methods Two remote audio/video recorded focus groups were conducted, one with the study’s clinicians and one with the peers. Participants were asked their views of key elements for successful implementation and outcomes of the Peer TeleHCV model. Group interviews lasted one hour. Recordings were professionally transcribed for thematic analysis with a mixed deductive and inductive framework, using Atlas.ti. Patients were surveyed about their interactions and satisfaction with peers. Results Quantitative data (n = 78) indicated patients had high levels of satisfaction with and support from the peers. Three themes were identified from the qualitative data (n = 12) including. (1) Key peer-level elements such as providing support during potentially difficult lab draws, creating a peer-facilitated “bubble of trust” between patients and clinicians, enabling technology access, conducting outreach to maintain contact and support treatment retention, and facilitating stabilizing wrap-around services (e.g., housing vouchers) (2) Key clinician-level factors such as capacity for unscheduled peer-facilitated appointments, having dedicated time for case consults with peers, and clinicians trained in working with PWUD and skilled in identifying related clinical concerns (3) Key systems-level elements such as standing lab orders, challenges related to specialty pharmacies and Medicaid managed care organizations, and streamlined communication strategies between peers and clinicians. Conclusion All participants reported that the Peer TeleHCV model built trust and eased barriers for PWUD initiating and remaining in HCV treatment. This low-barrier model makes space for PWUD to receive HCV treatment, regardless of drug use. Implementing support from peer specialists, telemedicine technology, and streamlined testing and treatment strategies may connect more rural PWUD living with HCV with the cure.