Journal Article > ResearchAbstract Only
J Viral Hepat. 2 May 2020; Volume 27 (Issue 9); 886-895.; DOI:10.1111/jvh.13311
Zhang M, O'Keefe D, Iwamoto M, Sann K, Kien A, et al.
J Viral Hepat. 2 May 2020; Volume 27 (Issue 9); 886-895.; DOI:10.1111/jvh.13311
Safe and efficacious pan-genotypic direct-acting antiviral (DAA) regimens, such as sofosbuvir and daclatasvir (SOF+DCV) facilitate simplified models of care for hepatitis C virus (HCV). However, in Cambodia access to HCV testing and treatment has typically been low. In response, Médecins Sans Frontières(MSF) implemented a HCV testing and treatment pilot project in Phnom Penh, Cambodia in 2016. This project provides the first real-world evidence of SOF+DCV effectiveness across a large patient cohort using a simplified care model in Cambodia. Patients treated with SOF+DCV from September 2016 to June 2019 were included in the analysis. Medical standard operational procedures (SOPs) were simplified significantly across the study period. Treatment effectiveness was assessed by sustained viral response at 12 weeks post-treatment (SVR12) according to a modified intention to treat methodology. Treatment safety was assessed by clinical outcome and occurrence of serious and non-serious adverse events (S/AE). Of 9158 patients, median age was 57 years and 39.6% were male. At baseline assessment, 27.2% of patients had compensated cirrhosis and 2.9% had decompensated cirrhosis. Genotype 6 was predominant (53.0%). Among patients analysed according to modified intention to treat (n=8525), treatment effectiveness was high, with 97.2% of patients achieving SVR12. Occurrence of SAE was low (0.7%). Treatment effectiveness and safety was not affected by the iterative simplification to treatment modality. In conclusion, in this large treatment cohort in Phnom Penh, Cambodia, the SOF+DCV regimen showed high rates of treatment effectiveness and safety across patient sub-groups and during progressive simplification.
Journal Article > ResearchFull Text
J Viral Hepat. 4 November 2020; Volume 28 (Issue 2); 268-278.; DOI:10.1111/jvh.13422
Mafirakureva N, Lim AG, Khalid GG, Aslam K, Campbell L, et al.
J Viral Hepat. 4 November 2020; Volume 28 (Issue 2); 268-278.; DOI:10.1111/jvh.13422
Despite the availability of effective direct-acting antiviral (DAA) treatments for Hepatitis C virus (HCV) infection, many people remain undiagnosed and untreated. We assessed the cost-effectiveness of a Médecins Sans Frontières (MSF) HCV screening and treatment programme within a primary health clinic in Karachi, Pakistan. A health state transition Markov model was developed to estimate the cost-effectiveness of the MSF programme. Programme cost and outcome data were analysed retrospectively. The incremental cost-effectiveness ratio (ICER) was calculated in terms of incremental cost (2016 US$) per disability-adjusted life year (DALY) averted from the provider's perspective over a lifetime horizon. The robustness of the model was evaluated using deterministic and probabilistic sensitivity analyses (PSA). The ICER for implementing testing and treatment compared to no programme was US$450/DALY averted, with 100% of PSA runs falling below the per capita Gross Domestic Product threshold for cost-effective interventions for Pakistan (US$1,422). The ICER increased to US$532/DALY averted assuming national HCV seroprevalence (5.5% versus 33% observed in the intervention). If the cost of liver disease care was included (adapted from resource use data from Cambodia which has similar GDP to Pakistan), the ICER dropped to US$148/DALY, while it became cost-saving if a recently negotiated reduced drug cost of $75/treatment course was assumed (versus $282 in base-case) in addition to cost of liver disease care. In conclusion, screening and DAA treatment for HCV infection are expected to be highly cost-effective in Pakistan, supporting the expansion of similar screening and treatment programmes across Pakistan.
Journal Article > ResearchFull Text
J Viral Hepat. 12 March 2022; Online ahead of print; DOI: 10.1111/jvh.13672
Morgan JR, Marsh E, Savinkina A, Shilton S, Shadaker S, et al.
J Viral Hepat. 12 March 2022; Online ahead of print; DOI: 10.1111/jvh.13672
Achieving global elimination of hepatitis C virus requires a substantial scale-up of testing. Point-of-care HCV viral load assays are available as an alternative to laboratory-based assays to promote access in hard to reach or marginalized populations. The diagnostic performance and lower limit of detection are important attributes of these new assays for both diagnosis and test of cure. Therefore, our objective was to determine an acceptable LLoD for detectable HCV viraemia as a test for cure, 12-weeks post-treatment (SVR12). We assembled a global dataset of patients with detectable viraemia at SVR12 from observational databases from 9 countries (Egypt, the United States, United Kingdom, Georgia, Ukraine, Myanmar, Cambodia, Pakistan, Mozambique), and two pharmaceutical-sponsored clinical trial registries. We examined the distribution of HCV viral load at SVR12 and presented the 90th , 95th, 97th, and 99th percentiles. We used logistic regression to assess characteristics associated with low-level virological treatment failure (defined as <1000 IU/mL). There were 5,973 cases of detectable viremia at SVR12 from the combined dataset. Median detectable HCV RNA at SVR12 was 287,986 IU/mL. The level of detection for the 95th percentile was 227 IU/mL (95% CI 170-276). Females and those with minimal fibrosis were more likely to experience low-level viremia at SVR12 compared to men (adjusted odds ratio AOR = 1.60 95% confidence interval [CI] 1.30-1.97 and those with cirrhosis (AOR=1.49 95% CI 1.15-1.93). In conclusion, an assay with a level of detection of 1000 IU/mL or greater may miss a proportion of those with low-level treatment failure
Journal Article > CommentarySubscription Only
J Viral Hepat. 5 August 2013; Volume 20 (Issue 9); 600-601.; DOI:10.1111/jvh.12123
Lemoine M, Thursz M, Gore C, Swan T, Kamarulzaman A, et al.
J Viral Hepat. 5 August 2013; Volume 20 (Issue 9); 600-601.; DOI:10.1111/jvh.12123
Journal Article > ResearchFull Text
J Viral Hepat. 26 July 2018; Volume 25 (Issue 12); DOI:10.1111/jvh.12974
Bilounga Ndongo C, Eteki L, Siedner MJ, Mbaye R, Chen JH, et al.
J Viral Hepat. 26 July 2018; Volume 25 (Issue 12); DOI:10.1111/jvh.12974
Hepatitis B virus (HBV) infection is hyperendemic in Cameroon, and health care workers (HCWs) are at high-risk of infection. We aimed to assess prevalence, risk factors and vaccine coverage of HBV infection among HCWs in Cameroon. We conducted a cross-sectional study in 16 hospitals across all regions of Cameroon. HCWs were tested for HBV using rapid diagnostic tests (RDT). We collected data on socio-demographics and HBV vaccination status. We estimated prevalence of HBV and used Poisson regression models with robust standard errors to model the prevalence ratios of HBV positivity between covariates. We enrolled 1,824 of 1,836 eligible HCWs (97.5%). The mean age was 34 (SD: 10) years, 65.3% (n=1787) were women, and 11.4% (n=1747) had three or more doses of the HBV vaccine. Overall, we found a HBV prevalence of 8.7% (95% CI: 5.2 - 14.3%). Patient transporters had the highest crude prevalence (14.3%; 95%CI: 5.4-32.9%), whereas medical doctors had the lowest (3.2%; 95%CI: 0.8%-12.1%). The Far North Region had the highest prevalence of HBV (24.0%; 95%CI: 18.3%-30.8%). HBV prevalence decreased with increasing doses of the HBV vaccine (10.3% for no doses vs 3.5% for three or more doses; P<0.001). In conclusion, approximately 1 in 12 HCWs in Cameroon have evidence of HBV infection, yet fewer than 1 in 6 have been fully vaccinated. Our results illustrate the urgent need to scale up systematic HBV screening and targeted vaccination of HCWs in the region. This article is protected by copyright. All rights reserved.
Journal Article > ResearchFull Text
J Viral Hepat. 3 December 2018; Volume 26 (Issue 1); 38-47.; DOI:10.1111/jvh.13002
Iwamoto M, Calzia A, Dublineau A, Rouet F, Nouhin J, et al.
J Viral Hepat. 3 December 2018; Volume 26 (Issue 1); 38-47.; DOI:10.1111/jvh.13002
GeneXpert® (Cepheid) is the only WHO prequalified platform for hepatitis C virus (HCV) nucleic acid amplification testing that is suitable for point-of-care use in resource-limited contexts. However, its application is constrained by the lack of evidence on genotype 6 (GT6) HCV. We evaluated its field performance among a patient population in Cambodia predominantly infected with GT6. Between August and September 2017, we tested plasma samples obtained from consenting patients at Médecins Sans Frontières' HCV clinic at Preah Kossamak Hospital for HCV viral load (VL) using GeneXpert® and compared its results to those obtained using COBAS® AmpliPrep/Cobas® TaqMan® HCV Quantitative Test, v2.0 (Roche) at the Institut Pasteur du Cambodge. Among 769 patients, 77% of the seropositive patients (n = 454/590) had detectable and quantifiable VL using Roche and 43% (n = 195/454) were GT6. The sensitivity and specificity of GeneXpert® against Roche were 100% (95% CI 99.2, 100.0) and 98.5% (95% CI 94.8, 99.8). The mean VL difference was -0.01 (95% CI -0.05, 0.02) log10 IU/mL for 454 samples quantifiable on Roche and -0.07 (95% CI -0.12, -0.02) log10 IU/mL for GT6 (n = 195). The limit of agreement (LOA) was -0.76 to 0.73 log10 IU/mL for all GTs and -0.76 to 0.62 log10 IU/mL for GT6. Twenty-nine GeneXpert® results were outside the LOA. Frequency of error and the median turnaround time (TAT) for GeneXpert® were 1% and 0 days (4 days using Roche). We demonstrated that the GeneXpert® HCV assay has good sensitivity, specificity, quantitative agreement, and TAT in a real-world, resource-limited clinical setting among GT6 HCV patients.