OBJECTIVES: The aim of this extension study was to investigate the long-term safety and efficacy of rVIII-SingleChain prophylaxis in ≥200 previously treated patients (PTPs) with hemophilia A with ≥100 exposure days (EDs).
METHODS: In total, 222 patients were enrolled, of which 204 rolled over from prior rVIII-SingleChain studies. The median age was 21 years (range, 2-65 years), including 155 patients ≥12 years and 67 patients <12 years. Patients continued with their previously assigned dose and regimen, or switched at the investigator's discretion. Patients were treated for a mean duration of 31 months (range, 1-47 months), the mean ED was 342 (standard deviation, 135.5), and 212 (95.5%) patients achieved >100 EDs. When the study ended, most patients were on either a prophylaxis regimen of 34.9 (17-62) IU/kg, 3×/week (N = 88; 39.6%), or 37.2 (13-65) IU/kg, 2×/week regimen (N = 72; 32.4%).
RESULTS: Hemostatic efficacy was rated excellent or good in 87.1% of assessed bleeds. The median (range) annualized bleeding rate was 1.21 (0.0-42.6), and the annualized spontaneous bleeding rate (AsBR) was 0.32 (0.0-33.0) for prophylaxis regimens. Median AsBR was similar for patients treated 3×/week and 2×/week (0.31 and 0.30, respectively). Surgical hemostatic efficacy was rated excellent or good in 100% of surgeries. No inhibitors, anaphylactic reactions, or thromboembolic events were reported in PTPs.
CONCLUSION: These results confirm the safety and efficacy of rVIII-SingleChain as a long-term prophylaxis treatment modality for PTPs with severe hemophilia A.
OBJECTIVE: To develop awareness and skills for the screening and identification of cases with bleeding symptoms among ASHAs in Udupi District, Karnataka, India.
METHODS: An interventional study was undertaken in Udupi District, which has three taluks and approximately 233 villages. All ASHAs with a current role (586) from rural Udupi were provided a competency-based training program at the community health center using a specifically designed training manual for the identification of cases with bleeding disorders. A pre-test/post-test evaluation was performed to discover the training outcomes.
RESULTS: Sixteen (2.7%) participants had average knowledge in the first post-test, and 570 (92.2%) participants had good knowledge. Thirty-nine (6.6%) participants had average knowledge in second post-test, and 547 (94.3%) participants had good knowledge. The effectiveness of the training program was assessed using Friedman's two-way test. A significant difference in knowledge scores (χ2 = 955.1) was found at baseline evaluation and end of the training test 1 and at 30 days of training test 2 among the ASHAs.
CONCLUSION: Accredited social heath activists health care workers, who are the most important link between the community and health services, successfully created public awareness concerning the early detection of bleeding disorders.