a two-year outcome evaluation of government-led initiative to upscale hospital-based hepatitis c treatment using a standard two-drug regimen 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-fitsall 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.