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) log IU/mL for 454 samples quantifiable on Roche and -0.07 (95% CI -0.12, -0.02) log IU/mL for GT6 (n = 195). The limit of agreement (LOA) was -0.76 to 0.73 log IU/mL for all GTs and -0.76 to 0.62 log 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.

The importance of measuring the quality of cancer care has been well recognized in many developed countries, but has never been successfully implemented on a national level in Japan. We sought to establish a wide‐scale quality monitoring and evaluation program for cancer by measuring 13 process‐of‐care quality indicators (QI) using a registry‐linked claims database. We measured two QI on pre‐treatment testing, nine on adherence to clinical guidelines on therapeutic treatments, and two on supportive care, for breast, prostate, colorectal, stomach, lung, liver and cervical cancer patients who were diagnosed in 2011 from 178 hospitals. We further assessed the reasons for non‐adherence for patients who did not receive the indicated care in 26 hospitals. QI for pretreatment testing were high in most hospitals (above 80%), but scores on adjuvant radiation and chemoradiation therapies were low (20–37%), except for breast cancer (74%). QI for adjuvant chemotherapy and supportive care were more widely distributed across hospitals (45–68%). Further analysis in 26 hospitals showed that most of the patients who did not receive adjuvant chemotherapy had clinically valid reasons for not receiving the specified care (above 70%), but the majority of the patients did not have sufficient reasons for not receiving adjuvant radiotherapy (52–69%) and supportive care (above 80%). We present here the first wide‐scale quality measurement initiative of cancer patients in Japan. Patients without clinically valid reasons for non‐adherence should be examined further in future to improve care.

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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 nonserious 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.

In Cambodia, little epidemiological data of hepatitis C virus (HCV) is available. All previous studies were limited to only small or specific populations. In the present study, we performed a characterization of HCV genetic diversity based on demography, clinical data, and phylogenetic analysis of HCV non-structural 5B (NS5B) sequences belonging to a large cohort of patients (n = 3,133) coming from majority part of Cambodia between September 2016 and December 2017. The phylogenetic analysis revealed that HCV genotype 1 and 6 were the most predominant and sharing equal proportions (46%). The remaining genotypes were genotype 2 (4.3%) and unclassified variants (3.6%). Among genotype 1, subtype 1b was the most prevalent subtype accounting for 94%. Within genotype 6, we observed a high degree of diversity and the most common viral subtypes were 6e (44%) and 6r (23%). This characteristic points to the longstanding history of HCV in Cambodia. Geographic specificity of viral genotype was not observed. Risks of HCV infection were mainly associated with experience of an invasive medical procedure (64.7%), having partner with HCV (19.5%), and blood transfusion (9.9%). In addition, all of these factors were comparable among different HCV genotypes. All these features define the specificity of HCV epidemiology in Cambodia.