Purpose
Limited literature on the prevalence of baseline resistance associated substitutions (BL-RAS) among HCV–HIV co-infected patients and their association with treatment outcomes is available especially from India. Hence, the present study aimed to study naturally occurring RAS among non-cirrhotic HCV–HIV co-infected patients and their impact on the response to anti-HCV therapy.
Patients and Methods
In this retrospective study, archived blood samples of 80 HCV–HIV co-infected patients, before anti-HCV therapy initiation, were tested for substitutions at the drug acting sites (NS5a and NS5b) in the HCV genome by direct PCR sequencing.
Results
BL-RAS were seen in 19 (23.7%) patients. As well as BL-RAS, all patients were given sofosbuvir (SOF) 400 mg+ daclatasvir (DCV) 60 mg for 12 weeks. Overall, sustained virological response (SVR) was achieved in 63 (78.8%) patients, in 13 with BL-RAS and in 50 without BL-RAS. All the SVR failure cases (n=17) were retreated with SOF (400 mg) +DCV (60 mg)+ ribavirin (RBV) for 24 weeks. SVR was eventually attained in 14 (82.3%) patients, in 4/6 (66.6%) with BL-RAS and in 10/11 (91%) without BL-RAS. On univariate analysis, age more than 30 years (OR: 11.6; 95% CI: 3.0–45.5, p-value<0.001) and female gender (OR: 8.6; 95% CI: 1.1−69, p-value <0.009) were found to be significant factors associated with the attainment of SVR.
Conclusion
BL-RAS are common in HCV–HIV co-infected patients. The existence of BL-RAS, however, did not affect the attainment of SVR among non-cirrhotic, treatment naive HCV–HIV co-infected patients.
Introduction: Estimation of hepatitis B (HBV) viral load (VL) is critical in hepatitis-B cascade-of-care and currently there is no point of care (POC) molecular assay available for that. This study evaluated the performance of a new near point of care molecular assay Xpert HBV-VL assay against FDA approved Real-time PCR assays.
Materials & methods: In this retrospective study 119 archived plasma samples from HBV infected patients, and 53 hepatitis B surface antigen (HBsAg) patients were simultaneously tested for HBV DNA quantification on 2 real-time PCR conventional assays and Xpert assay. The routine method for reporting to the patient was Abbott Real-Time PCR.
Results: The range of HBV DNA load in samples was 1 to 8.76 log10IU/ml with a median load of 4.46 (IQR: 1-8.76) log10IU/ml as detected by routine assay (Abbott Real-Time HBV VL assay). Genotyping could be done in 95 (79.8%) samples and genotype D (83; 87.37%) was found commonest. The Xpert assay demonstrated a good correlation with Abbott (R2= 0.944) and Roche (R2= 0.963). On comparison, the mean difference (95% Confidence Interval) in average viral load was -0.018 log10 IU/ml and -0.043 log10 IU/ml when Xpert was compared with the Abbott and Roche assay, respectively. The overall sensitivity, specificity, negative predictive value, and positive predictive value of the Xpert assay was found 97.5%, 100%, 94.65 & 100% respectively.
Conclusion: Xpert HBV-VL assay which has a potential for near point of care molecular testing has shown excellent performance and found to be a reliable method for HBV DNA quantification.
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