A new retrospective cohort study has reported a significant success in the treatment of chronic hepatitis C virus (HCV) infection using a regimen of glecaprevir and pibrentasvir (GLE/PIB) in Saudi Arabia. The research was conducted at the Prince Sultan Military Medical City in Riyadh, observing the outcomes amongst a group of adult patients treated between February 2020 and March 2021. This study is a pivotal move towards combating the disease in the Kingdom, being in line with the country’s dedicated efforts to control, and ultimately, eliminate HCV.
DOI: 10.15537/smj.2024.45.1.20230236
The Burden of Hepatitis C in Saudi Arabia
The World Health Organization (WHO) highlighted hepatitis C as a global health threat with significant morbidity and mortality (World Health Organization, 2017). Chronic hepatitis C can lead to severe liver diseases, including cirrhosis and hepatocellular carcinoma. In the Kingdom of Saudi Arabia, the prevalence of HCV genotypes poses unique challenges, with genotype 4 being predominately seen among the affected population (Aljumah et al., 2016).
Since the direct-acting antiviral agents (DAAs) arrived on the scene, they have revolutionized HCV treatment with their increased effectiveness and improved safety profiles compared to the previously used interferon-based therapies. Among the DAAs, the combination of glecaprevir (a viral protease inhibitor) and pibrentasvir (an NS5A inhibitor), known as GLE/PIB, offers a pan-genotypic treatment option, which is particularly important for regions like Saudi Arabia where non-genotype 1 HCV is prevalent.
Study Overview and Findings
The study published in the Saudi Medical Journal included 92 patients with various backgrounds: both treatment-naive and experienced, with and without cirrhosis, and with normal kidney function or chronic kidney disease (Ruwayni et al., 2024). The primary end-point was the number and percentage of patients who achieved a sustained virologic response 12 weeks after treatment (SVR12), which is considered a cure for the infection.
The findings were encouraging, with 98.9% of the patients achieving SVR12, implying that GLE/PIB is highly effective in treating chronic HCV patients in Saudi Arabia. It is noteworthy that one patient experienced virologic non-response. Yet, importantly, no serious adverse events leading to treatment discontinuation occurred, affirming the safety of the regimen.
A Concern Regarding Treatment Duration
The study, however, raised a concern about adherence to treatment duration guidelines. Approximately 75% received an unintended 12-week treatment course rather than the FDA-recommended eight weeks. This exposes a gap in adhering to guidelines, which may have implications for healthcare costs and resistance development.
Global Context and Recommendations
The European Association for the Study of the Liver has been emphasizing the importance of following prescribed treatment durations to ensure efficacy and to prevent the emergence of resistant virus strains (The European Association for the Study of the Liver, 2018). This is echoed by the recommendations of the American Association for the Study of Liver Diseases-Infectious Diseases Society of America (Ghany & Morgan, 2020). Aligning with these guidelines can also result in a reduced treatment burden for patients and a more cost-effective use of healthcare resources.
Implications for Chronic Kidney Disease Patients
Remarkably, the study sheds light on patients with chronic kidney disease, who historically have had limited treatment options due to the increased risk of medication-induced adverse events. GLE/PIB’s safety profile stands out for this high-risk group, which is corroborated by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines indicating the necessity for safe and effective treatment options for HCV patients with kidney impairment (Levin et al., 2013).
Concluding Remarks
This study by Ruwayni et al. (2024) presents critical evidence supporting the use of GLE/PIB for the treatment of HCV, showcasing not only high effectiveness but also a reassuring safety profile across a diverse patient population. It stresses the importance of adherence to treatment guidelines and the potential of GLE/PIB to serve as a key regimen in the fight against HCV in Saudi Arabia.
References
1. Ruwayni Ali A, AlObary Eman E, Alyahya Khalid M. Efficacy and safety of glecaprevir and pibrentasvir in Saudi patients with chronic hepatitis C virus infection at a major tertiary hospital. Saudi Med J 2024 Jan; 45(1): 34-39. DOI: 10.15537/smj.2024.45.1.20230236
2. World Health Organization. Global hepatitis report 2017. [Updated 2017; Accessed 2022 June 1]. Available from: https://www.who.int/hepatitis/publications/global-hepatitis-report2017/en
3. Aljumah AA, Abaalkhail F, Al-Ashgar H, et al. Epidemiology, disease burden, and treatment strategies of chronic hepatitis C virus infections in Saudi Arabia in the new treatment paradigm shift. Saudi J Gastroenterol 2016; 22: 269-281. DOI: PMC4991197
4. The European Association for the Study of the Liver. Special report: hepatitis C elimination plan consensus recommendations for the Kingdom of Saudi Arabia. [Updated 2018; Accessed 2022 July 6]. Available from: https://easl-ilf.org/wp-content/uploads/2018/12/saudi.pdf
5. Ghany MG, Morgan TR. Hepatitis C guidance 2019 update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America recommendations for testing, managing, and treating hepatitis C virus infection. Hepatology 2020; 71: 686-721. DOI: PMC9710295
6. Levin A, Stevens PE, Bilous RW, et al. Kidney disease: improving global outcomes (KDIGO). CKD Work Group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int Sup 2013; 3: 1-150.
Keywords
1. Hepatitis C Treatment Saudi Arabia
2. Glecaprevir Pibrentasvir Efficacy
3. Chronic HCV Infection Therapy
4. Antivirals Hepatitis C
5. Saudi Medical Journal HCV Study