SUSTAINED VIROLOGIC RESPONSE OF PATIENTS WITH CHRONIC HEPATITIS C BEFORE TREATED WITH DAAs AT 2 TROPICAL HOSPITALS

Hương Vũ Thị Thu, Hiếu Nguyễn Trọng, Thạch Phạm Ngọc, Barnady Flower, Thuận Đặng Trọng, Châu Lê Ngọc, Rogier Van Doorn, Graham Cooke

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Abstract

Objective: To describe the sustained virologic response (SVR) results of patients with chronic hepatitis C treated with direct-acting antivirals (DAAs) at the National Hospital for Tropical Diseases (NHTD) and the Hospital for Tropical Diseases in Ho Chi Minh City (HTD). Methods: This is a randomized controlled clinical trial. Patients will be randomly assigned to two groups with a ratio of 1:1. Results: Of the 250 patients participating in the study, 73.2% were male and 27.8% were female. The mean age of the study subjects was approximately 48 years. The duration of hepatitis C infection in group 1 (response-directed treatment) was 4.2 years and in group 2 (standard treatment regimen) was 3.7 years. After 7 days of treatment, 22.6% of the patients in the study group achieved a viral load below the limit of detection (LLOQ), allowing treatment for 4 weeks. Approximately 60.5% of patients had a viral load between the LLOQ and 250 IU/ml and required 8 weeks of treatment, while the remaining 16.9% had a viral load above 250 IU/ml and required 12 weeks of treatment. Comparing the 2 regimens in the response-based treatment group (Group 1) and the standard treatment group (Group 2) at 12 weeks of treatment, the rate of patients achieving DNPH virus was 100%. The sustained virological response rate (SVR12) of the entire response-based treatment group was 93.1%. However, the SVR12 rate of the 8-week treatment group reached 97.1%, not inferior to the standard treatment group at 98.4%. Conclusion: These results showed that the majority of patients had a significant reduction in viral load after 7 days of treatment. The SVR12 rate in the 8-week treatment group was non-inferior to the standard treatment group.

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References

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