The accuracy and cost-effectiveness of hepatitis C core antigen assay in the monitoring of anti-viral therapy in patients with chronic hepatitis C genotype 4.

BACKGROUND: Quantitative hepatitis C (HCV) polymerase chain reaction (qtHCV-PCR), the gold standard for monitoring HCV therapy, is an expensive, time-consuming procedure that requires equipped laboratories and trained personnel. AIMS: To assess the accuracy and cost-effectiveness of the automated Abbott ARCHITECT HCV Ag assay (Wiesbaden, Germany) in monitoring response to pagylated interferon (PEG-IFN) and ribavirin therapy for chronic HCV genotype 4 (G4). METHODS: This longitudinal, non-inferiority study compared the efficacy and cost benefit of an All-HCV core antigen assay protocol and a hybrid qtHCV RNA PCR and HCV core Ag assay protocol to the standard All-qtHCV-PCR protocol in chronic HCV G4 patients treated with pegylated interferon (PEG IFN) and ribavirin. RESULTS: Four hundred and ten patients with chronic hepatitis C genotype 4 met inclusion criteria and were enrolled in the study. The sustained virological response rate (SVR) was 66.34%. The All-HCV core antigen and hybrid monitoring assays resulted in the significant cost savings without compromising performance. A good correlation existed between HCV viral load and HCV core antigen levels (r = 0.944; P < 0.0001). Baseline HCV RNA values <600 IU/mL, baseline HCV core Ag levels <2000 fmol/L, rapid virological response, rapid decline in HCV core antigen were strong predictors of SVR. CONCLUSION: Hepatitis C core Ag assay is a point-of-care, reproducible, reliable, cost-effective monitoring tool with rapid turnaround time that, which can effectively replace or adjunct to qRT-PCR in monitoring interferon based or interferon-free anti-viral therapy in chronic hepatitis genotype 4 patients in resource-limited countries with a high burden of hepatitis C.

Genital Chlamydia trachomatis infection in Egyptian women: incidence among different clinical risk groups.

OBJECTIVE: To investigate genital Chlamydial infection incidence among high risk clinical conditions in Egyptian women. METHODS: A case control study in Ain Shams University Hospital involving 501 patients with cervicitis (n = 58), abnormal cervical smear (n = 256), tubal infertility (n = 85), ectopic pregnancy (n = 22), preterm labour (n = 80) and 192 controls. Active cervical Chlamydial infection was diagnosed using direct immunofluorescent technique. Data were analyzed by Chi-square (chi 2) and Z tests. RESULTS: Significant increase of Chlamydial infection among different clinical conditions compared to controls. The percentage of positive chlamydial infection was 79.3% among cervicitis group, 33.3% among subjects with inflammatory smear, 75.2% among those with cervical condyloma, 82.6% among those with cervical intraepithelial neoplasia, 51.8% among tubal infertility subjects, 77.2% among ectopic patients and 56.3% among subjects with preterm labour. CONCLUSION: The incidence of Chlamydial infection in these high risk Egyptian patients is relatively high. Emperical treatment is recommended as the diagnosis is costly and usually not available.