Efficacy of generic sofosbuvir with daclatasvir compared to sofosbuvir/ledipasvir in genotype 4 hepatitis C virus: A prospective comparison with historical control

Background and Aim Management of genotype 4 hepatitis C virus (HCV) has shifted to interferon‐free regimens with a high sustained virological response (SVR‐12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof‐Led). The guidelines have recommended the combinati...

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Published in:	Health science reports Vol. 6; no. 1; pp. e980 - n/a
Main Authors:	Joharji, Hala, Alkortas, Delal, Ajlan, Aziza, Ahmed, Mohamed, Al‐Ashgar, Hamad, Al‐Quaiz, Mohammed, Broering, Dieter, Al‐Sebayel, Mohammed, Elsiesy, Hussien, Alkhail, Faisal A., Al‐Hamoudi, Waleed K., De Vol, Edward, Amirah Almuhayshir, Epi, Al‐Jedai, Ahmed
Format:	Journal Article
Language:	English
Published:	United States John Wiley & Sons, Inc 01-01-2023 John Wiley and Sons Inc Wiley
Subjects:	Antiviral drugs Clinical outcomes Cost control cost saving Data collection direct acting antivirals Generic drugs Genotype & phenotype Hepatitis C Liver cancer Original Research Patients sustained virological response Transplants & implants viral hepatitis Saudi Arabia Riyadh Saudi Arabia viral hepatitis direct acting antivirals sustained virological response cost saving
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Summary:	Background and Aim Management of genotype 4 hepatitis C virus (HCV) has shifted to interferon‐free regimens with a high sustained virological response (SVR‐12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof‐Led). The guidelines have recommended the combination of sofosbuvir and another NS5A inhibitor, daclatasvir, to manage HCV genotypes 1–3. However, its use was extended to genotype 4 HCV based on extrapolating evidence. Our aim is to assess the efficacy of generic sofosbuvir + branded daclatasvir (Sof‐Dac) compared to the Sof‐Led combination in treating genotype 4 HCV. Methods This study is an open‐label, 2‐period, noninferiority study that compared patients receiving a combination of generic sofosbuvir 400 mg and daclatasvir 60 mg orally daily (Group 2) prospectively to a historical control (Group 1) that included patients who received a combination of sofosbuvir/ledipasvir 400/90 mg orally daily. The primary endpoint is the proportion of patients who achieved SVR‐12. Results The study included 111 patients in the (Sof‐Led) Group 1 and 109 patients (Sof‐Dac) Group 2. For the primary outcome, SVR‐12 was achieved in 106 (95.5%) of the patients in Group 1 versus 108 (99.1%) in Group 2 (p = 0.2). In addition, all patients who achieved SVR‐12 also achieved SVR‐24. Conclusion Generic sofosbuvir combined with branded daclatasvir was safe and effective for treating genotype 4 HCV compared to Sof‐Led. This combination may significantly reduce the cost burden, enabling a larger pool of treated patients. Office of research affairs at KFSHRC RAC# 2171 036.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2398-8835 2398-8835
DOI:	10.1002/hsr2.980