BACKGROUND
Hepatitis C virus (HCV) antibody self-testing (HCVST) may help expand screening access and support HCV elimination efforts. Despite potential benefits, HCVST is not currently implemented in Pakistan. This study aimed to assess the usability and acceptability of HCVST in a high HCV prevalence informal settlement in Karachi, Pakistan.
METHODS
We performed a cross-sectional study in a hepatitis C clinic from April through June 2023. Participants were invited to perform a saliva-based HCVST (OraSure Technologies, USA) while following pictorial instructions. A study member evaluated test performance using a standardized checklist and provided verbal support if a step could not be completed. Perceived usability and acceptability were assessed using a semi-structured questionnaire. The HCVST was considered successful if the participant was able to complete all steps and correctly interpret test results. Overall concordance and positive and negative agreement were estimated in comparison with the HCVST result read by the study member (inter-reader concordance and agreement) and result of a second rapid HCV test (Abbott Diagnostics Korea Inc, South Korea) performed by a trained user (inter-operator concordance and agreement).
RESULTS
The study included 295 participants of which 97 (32%) were illiterate. In total, 280 (95%, 95% CI 92–97%) HCVSTs were successful. Overall, 38 (13%) people performed the HCVST without verbal assistance, 67 (23%) needed verbal assistance in one step, 190 (64%) in two or more. Assistance was most often needed in managing the test buffer and test reading times. The inter-reader concordance was 96% and inter-operator concordance 93%. Inter-reader and inter-operator positive percent agreement were 84 and 70%, respectively. All participants reported they would use HCVST again and would recommend it to friends and family.
CONCLUSION
Saliva-based HCVST was very well accepted in this clinic-based setting. However, many people requested verbal support in several steps, highlighting the need for clear instructions for use and test devices that are simple to use, particularly in low literacy settings. Moderately low positive percent agreement with the results of a rapid test performed by a trained user highlights potential uncertainty in the accuracy of HCVST in the hands of lay users.
BACKGROUND
Hepatitis C virus (HCV) is a major cause of liver diseases globally. Transmission is primarily bloodborne through unsafe injections or healthcare practices. Effective treatment exists, yet access to diagnosis and treatment is limited. Few data indicated high HCV exposure among Rohingya refugees/FDMN residing in crowded camps in Cox’s Bazar District, Bangladesh, where Médecins Sans Frontières is pioneering HCV services. Representative information on the prevalence of active HCV infection and exposure risk factors was lacking.
METHODS
A cross-sectional survey was carried out in May-June 2023, including adults (≥18 years) by simple random geo-sampling (one participant per household, target sample 680), in seven camps (8W, 12, 13, 16, 17, 18, 19) in Cox’s Bazar District. Participants were screened with an HCV-antibody test (SD Bioline), and active infection assessed with Xpert® HCV Viral Load test (Cepheid) if seropositive. A structured questionnaire was administered to identify risk factors of exposure.
RESULTS
Of the 641 participants, median age was 34 years [IQR 28, 46], 66.3% were female. The estimated prevalence of HCV-seropositivity was 29.7% (95%CI: 26.0-22.8), and the prevalence of active infection was 19.6% (16.4-23.2). Multivariable regression revealed higher odds of HCV-seropositivity for female (adjusted odds ratio (aOR)=1.7 (1.0-2.6)), age groups ≥25 years old (aORs ranging from 2.3 to 2.9), reported medical injection(s) (aOR=1.7 (95% CI: 1.0-2.6)) or surgery (aOR=4.7 (95%CI: 1.3-16.7). Half of participants never heard about Hepatitis C, 4.0% of viremic participants reported previous HCV treatment.
CONCLUSION
The survey revealed a significant burden of active HCV infection among adult Rohingya camp residents, which, extrapolated may affect an estimated 86,000 individuals. Urgent action is required to expand diagnosis and treatment to prevent advanced liver disease and transmission. A collaborative task force with camp-based health stakeholders is now underway for a mass screening and treatment initiative, as well as a camp-wide HCV awareness campaign.
To determine whether a nurse-led model of care for patients with hepatitis C virus (HCV) infections can provide safe and effective diagnosis and treatment in a resource-poor setting in rural Cambodia.
METHODS
The nurse-led initiation pilot project was implemented by Médecins Sans Frontières in collaboration with the Cambodian health ministry in two operational districts in Battambang Province between 1 June and 30 September 2020. Nursing staff at 27 rural health centres were trained to identify signs of decompensated liver cirrhosis and to provide HCV treatment. Patients without decompensated cirrhosis or another comorbidity were initiated at health centres onto combined treatment with sofosbuvir, 400 mg/day, and daclatasvir, 60 mg/day, orally for 12 weeks. Treatment adherence and effectiveness were assessed during follow-up.
FINDINGS
Of 10 960 individuals screened, 547 had HCV viraemia (i.e. viral load = 1000 IU/mL). Of the 547, 329 were eligible for treatment initiation at health centres through the pilot project. All 329 (100%) completed treatment and 310 (94%; 95% confidence interval: 91-96) achieved a sustained virological response 12 weeks post-treatment. Depending on patient subgroups, this response varied from 89% to 100%. Only two adverse events were recorded; both were determined as unrelated to treatment.
CONCLUSION
The safety and effectiveness of direct-acting antiviral medication has previously been demonstrated. Models of HCV care now need to enable greater access for patients. The nurse-led initiation pilot project provides a model for use in other resource-poor settings to scale up national programmes.
Hepatitis C (HCV) programs face challenges, especially linked to key populations to achieve World Health Organization (WHO) goals of eliminating hepatitis. Médecins Sans Frontières and Mozambique's Ministry of Health first implemented HCV treatment in Maputo, in 2016 and harm reduction activities in 2017.
METHODS
We retrospectively analyzed routine data of patients enrolled between December 2016 and July 2021. Genotyping was systematically requested up to 2018 and subsequently in cases of treatment failure. Sustainable virological response was assessed 12 weeks after the end of treatment by sofosbuvir-daclatasvir or sofosbuvir-velpatasvir.
RESULTS
Two hundred and two patients were enrolled, with 159 (78.71%) males (median age: 41 years [interquartile range (IQR): 37.10, 47.00]). Risk factors included drug use (142/202; 70.29%). One hundred and eleven genotyping results indicated genotype 1 predominant (87/111; 78.37%). Sixteen patients presented genotype 4, with various subtypes. The people who used drugs and HIV coinfected patients were found more likely to present a genotype 1. Intention-to-treat analysis showed 68.99% (89/129) cure rate among the patients initiated and per-protocol analysis, 88.12% (89/101) cure rate. Nineteen patients received treatment integrated with opioid substitution therapy, with a 100% cure rate versus 59.37% (38/64) for initiated ones without substitution therapy (p < 0.001). Among the resistance testing performed, NS5A resistance-associated substitutions were found in seven patients among the nine tested patients and NS5B ones in one patient.
CONCLUSION
We found varied genotypes, including some identified as difficult-to-treat subtypes. People who used drugs were more likely to present genotype 1. In addition, opioid substitution therapy was key for these patients to achieve cure. Access to second-generation direct-acting antivirals (DAAs) and integration of HCV care with harm reduction are crucial to program effectiveness.
BACKGROUND
Globally, 9% of people who inject drugs (PWID), a key hepatitis C-infected population, reside in sub-Saharan Africa. In South Africa, hepatitis C seroprevalence in PWID is high. It is almost 84% in Pretoria and hepatitis C genotypes 1 and 3 predominate. Access to hepatitis C care for PWID is inadequate given low referral rates, socio-structural barriers, homelessness and limited access to harm reduction. Traditional care models do not address the needs of this population. We piloted a simplified complete point-of-service care model, a first of its kind in the country and sub-continental region.
METHODS
Community-based recruitment from Pretoria’s PWID population occurred over 11 months. Participants were screened with point-of-care rapid diagnostic tests for HBsAg (Alere Determine™), hepatitis C and HIV antibodies (OraQuick®). Qualitative HCV viremia was confirmed on site with Genedrive® (Sysmex), similarly at week 4, end of treatment and to confirm sustained virological response. Viremic hepatitis C participants were initiated on 12 weeks of daily sofosbuvir and daclatasvir. Harm reduction and adherence support, through directly observed therapy, peer support, a stipend and transport, was provided.
RESULTS
A total of 163 participants were screened for hepatitis C antibody, and 66% were positive with 80 (87%) viremic. An additional 36 confirmed hepatitis C viremic participants were referred. Of those eligible to initiate treatment, 87 (93%) were commenced on sofosbuvir and daclatasvir, with 98% (n = 85) male, 35% (n = 30) HIV co-infected, 1% (n = 1) HBV co-infected and 5% (n = 4) HIV/HBV/HCV triple infected. Some 67% (n = 58) accessed harm reduction packs, 57% (n = 50) opioid substitution therapy and 18% (n = 16) stopped injecting. A per protocol sustained virological response of 90% (n = 51) was achieved with 14% (n = 7) confirmed reinfections following a sustained virological response. HCV RNA qualitative testing performance was acceptable with all sustained virological responses validated against a laboratory assay. Mild adverse effects were reported in 6% (n = 5). Thirty-eight percent (n = 33) of participants were lost to follow-up.
CONCLUSION
In our setting, a simplified point-of-service hepatitis C care model for PWID yielded an acceptable sustained virological response rate. Retention in care and follow-up remains both challenging and central to success. We have demonstrated the utility of a model of care for our country and region to utilize this more community acceptable and simplified practice.