Letter to the Editor: Efficacy and safety of the generic forms of sofosbuvir/ledipasvir in chronic hepatitis C virus adolescents in Upper Egypt

Abstract

Mogahed et al recently published a retrospective study in the World Journal of Hepatology, which assessed the safety and efficacy of the generic sofosbuvir (SOF)/ledipasvir (LED) in Egyptian hepatitis C virus (HCV)-infected children in comparison with the brand form. They concluded that, the use of generic SOF/LED in HCV infected children is safe and effective. Previous study in 2021 on chronic HCV in adolescents used the generic SOF/LED at Assiut, Upper Egypt. Sustained virologic response (SVR12) was 100% both in treatment naïve with or without haematological disorders and in non-responder to pegylated interferon/ribavirin. The treatment was well tolerated, with minimal side effects. We also support the use of the generic forms of SOF/LED in HCV infected children and adolescents in Egypt and other resource limited countries.

Key Words: Adolescents; Hepatitis C virus; Generic; Ledipasvir; Sofosbuvir; Treatment naïve; Treatment experienced; Egypt

Core Tip: Using brand forms of direct acting antivirals (DAAs) against hepatitis C virus (HCV) is limited in low- and middle-income countries. Generic forms of DAAs were widely used in adults. Few studies addressed this issue in children and adolescents in Egypt. We support the use of the generic forms of sofosbuvir/ledipasvir in HCV infected children and adolescents.

TO THE EDITOR

We are delighted to read the high-quality article by Mogahed et al[1], published in the World Journal of Hepatology. The main focus of this retrospective study is providing real-world evidence on the safety and efficacy of generic sofosbuvir (SOF)/Ledipasvir (LED) combination in children and adolescents infected with chronic hepatitis C virus (HCV) in comparison with their corresponding brand forms at Cairo (Lower Egypt). The study included 116 Egyptian children and adolescents with chronic HCV infection. Forty-three patients received the generic form of SOF/LED (Ledisbuvir) for 12 weeks, while 73 patients received the brand form (Harvoni^®) for 12 weeks. End of treatment response and SVR12 were achieved in both groups (100% for each) with transient mild side effects. Headache and fatigue were most commonly reported side effects (37.2% for each). Irritability was reported in 30.2% and diarrhea in 11.6%[1]. Similarly, Makhlouf et al[2] prospectively included 65 chronic HCV adolescents (44 of them were treatment-naive without hematological disorders, 15 treatment-naive with hematological disorders, and 6 were previous nonresponders to pegylated interferon/ribavirin). All patients received generic SOF/LED combination in one tablet once daily for 12 weeks (generic drug, Sofolanork plus; Mash Premier, New Cairo City, Egypt). SVR12 was achieved in all patients (100%). All adverse events were mild, self-limited and observed 2 weeks of starting the drug regimen without treatment discontinuation. Headache was reported in 29.2%, diarrhea in 15.4%, while only 4.5% developed fatigue. In addition, at SVR12, significant improvement in the mean aspartate aminotransferase to platelet ratio index score and median liver stiffness were observed compared with baseline in all groups[2]. El-Khayat et al[3] evaluated SOF/LED treatment efficacy for 8 weeks vs 12 weeks in adolescent patients in Egypt. SVR12 was 97.6% in patients treated for 12 weeks, while it was 98.6% for those treated for 8 weeks. They concluded that eight weeks SOF/LED is equally effective and safe as 12 weeks with lower cost, higher treatment adherence and improved quality of life[3].

Adverse events were reported in 7% of 8 weeks group, where fatigue was 2.8%, while 1.4% was reported for each of headache, epigastric tenderness or nausea. In the other group, adverse events were reported in 8.3%, where 2.4% was reported for diarrhea and 2.4% for rash. However, each of nausea or epigastric tenderness or fatigue occurred in 1.2%[3]. However, El-Khayat et al[3] did not mention whether they used generic or brand SOF/LED combination.

Limitation

Small sample sizes of cited studies are considered as limitation.

Conclusion

We support the use of generic SOF/LED in children and adolescents with HCV infection. Generic SOF/LED regimen was safe and well tolerated with lower cost.