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Introduction Malaysia has been actively battling hepatitis C since 2016, primarily through partnerships with access-oriented nonprofit organizations and drug price control by compulsory licensing of sofosbuvir, a patented direct-acting antiviral. This study evaluated the impact of such initiatives on the treatment coverage, health expenditure of the government, and clinical outcomes of patients. Methods The data contributed by 144 public hospitals across the country was used to assess the trend changes in the number of hepatitis C patients treated and the corresponding drug expenditure between 2013 and 2019 (before and after government-driven interventions). The information on the effectiveness of the sofosbuvir-daclatasvir regimen was also gathered from medical records of hepatitis C patients, who sought care from 16 selected hospitals between April 2018 and March 2020. Results While the number of hepatitis C patients receiving treatment increased by >10 times (from 299 in 2013 to 3,116 in 2019; pConclusion The findings demonstrate the sustainability and scalability of the existing hepatitis C care model in Malaysia, along with the great real-world effectiveness of the treatment. [Disclaimer: Abstract text might vary slightly from what is displayed in the e-poster], This poster was submitted to the 14th National Conference for Clinical Research (NCCR) in August 18-20, 2021. https://nccrconference.com.my/ This poster is also shortlisted for 14th Dr Wu Lien-Teh Youth Investigator Awards. Following are the links for the presentation slides on Zenodo Repository and Slideshare: Zenodo Repository : https://zenodo.org/record/5348475 Slideshare : https://www.slideshare.net/ICRInstituteForClini/midterm-outcome-evaluation-of-governmentled-endeavors-to-eliminate-hepatitis-c-as-a-public-health-threat-by-2030-in-malaysia

Background: Malaysia has been fully committed to the global endeavor to eliminate hepatitis C virus (HCV) infection by 2030. In early 2018, the Ministry of Health (MOH) embarked on a “one-size-fits-all strategy” by introducing generic versions of sofosbuvir and daclatasvir as the standard treatment for HCV infection in public hospitals nationwide. Objectives: To evaluate the outcomes of such an initiative in multiple aspects, including the number and characteristics of patients treated, the extent of evidence-based drug use, the treatment completion status, individual responses to treatment, common side effects of treatment, and its economic implications. Methods: The findings were generated from the data compiled by the MOH, capturing the information regarding the treatment provided to adult HCV-infected patients in 16 selected hospitals between April 2018 and March 2020, along with the drug costs incurred. Results: A total of 1,797 patients were treated, nearly four times more than the patients receiving interferon-based treatment across the country in the preceding two years. Approximately one-third of them had liver cirrhosis, and the main HCV genotypes were 3 (46.9%) and 1a (20.0%). Dosing, treatment duration and the addition of ribavirin to the treatment generally agreed with the recommendations of the MOH. More than 90% of the patients completed the treatment course, and a sustained virologic response (SVR) rate of 95.4% (95% CI: 94.2, 96.7%) was recorded in those with a known treatment outcome (n = 1,163). The SVR achievement did not vary across HCV genotypes and cirrhosis status, but those ≥ 50 years of age (adjusted OR: 2.13; 95% CI: 1.16, 3.92) were more likely to fail the treatment. Side effects were rare. Anemia and fatigue caused treatment discontinuation in only 0.3% of the patients. The total drug expenditure reached US$678,258.20, and the mean cost of a 12-week treatment course of sofosbuvir and daclatasvir (US$235.16) was lower than the cost expected by the MOH (US$300). Conclusions: The findings demonstrate a high degree of real-world effectiveness, safety, and affordability of the standard treatment, suggesting that such a government-led initiative was reasonable and timely and could be extended to include more public health institutions.