SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial

Merat, Shahin and Merat, Shahin and Sharifi, Amir-Houshang and Poustchi, Hossein and Hajiani, Eskandar and Gharavi, Abdolsamad and Karimi, Jalal and Mansour-Ghanaei, Fariborz and Fattahi, Mohammad-Reza and Ahmadi, Lida and Somi, Mohammad-Hossein and Kalantari, Hamid and Ghadir, Mohammad-Reza and Sheikhesmaeili, Farshad and Baniasadi, Nadieh and Sohrabi, Masoudreza and Moosavy, Seyedhamid and Ziaee, Masood and Zahedi, Mohammad-Javad and Mokhtare, Marjan and Sali, Shahnaz and Sayad, Babak and Afshar, Behrooz and Bakhshipour, Alireza and Parsi, Abazar and Sharifian, Afsaneh and Amiriani, Taghi and Malekzadeh, Zeinab and Merat, Dorsa and Ganji, Azita and Rahmani-Samani, Fereidoun and Jamali, Raika and Sofian, Masoomeh and Ghezlou, Mohammad and Ali Sohrabpour, Amir and Goshayeshi, Ladan and Valizadeh-Toosi, Seyed-Mohammad and Eslami, Layli and Maleki, Iradj and Hormati, Ahmad and Shayesteh, Ali-Akbar and Shayesteh, Elahe and Norouzi, Alireza and Abna, Zahra and Janbakhsh, Alireza and Fakheri, Hafez and Minakari, Mohammad and Sardarian, Hossein and Fallah Ghajary, Adel and Fattahi-Abdizadeh, Mojtaba and Latifnia, Maryam and Roozbeh, Fatemeh and Agah, Shahram and Fakhrieh-Asl, Saba and Nateghi-Baygi, Alireza and Fattahi, Babak and Nateghi-Baygi, Helia and Hill, Andrew and Malekzadeh, Reza (2020) SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial. Clinical Infectious Diseases, 70 (10). pp. 2206-2212. ISSN 1058-4838

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Official URL: http://doi.org/10.1093/cid/ciz628

Abstract

Background. The combination of sofosbuvir and daclatasvir is a potent, pangenotypic regimen suitable for mass-scale hepatitis C treatment, especially in resource-limited countries where newer, expensive combinations are not available. This combination has been widely tested on genotype 4. However, Phase III trials of this combination in other genotypes have been cost prohibitive. With the introduction of generic, low-cost sofosbuvir and daclatasvir, large-scale studies in resource-limited countries are now possible. Methods. Sofosbuvir at 400 mg and daclatasvir at 60 mg were coformulated into a fixed-dose combination (FDC) tablet (Sovodak, Rojan Pharma, Tehran, Iran). Patients from 46 centers were dosed for 12 or 24 weeks with or without ribavirin, in line with existing guidelines. Responses to treatment were evaluated 12 weeks after the end of treatment (for a sustained virological response at Week 12; SVR12). Results. There were 1361 patients recruited. Overall, the patients were 21% female, with a mean age of 50 years; 39% were cirrhotic; 22% were treatment-experienced; 47% were genotype 1, 41% were genotype 3, and 2% were other genotypes. The genotype was not known in 10% of the patients. The intention-to-treat and per-protocol SVR12 rates were 94.7% and 98.8%, respectively. The safety profile was unremarkable, treatment was well tolerated, and compliance with the single-tablet regimen was excellent. Conclusions. The treatment with FDC of sofosbuvir and daclatasvir achieved high SVR12 rates, equivalent to those seen in Phase III trials of other pangenotypic options, and has been conducted at a similar scale in a representative, real-world population at a cost of under $100 per patient, which makes this combination suitable for elimination protocols in resource-limited countries. Keywords:sofosbuvir; daclatasvir; Hepatitis C; sustained virological response; generic drugs

Item Type: Article
Subjects: WI Digestive System
Divisions: Faculty of Medicine
Depositing User: zeynab . bagheri
Date Deposited: 09 Nov 2020 08:37
Last Modified: 09 Nov 2020 08:37
URI: http://eprints.skums.ac.ir/id/eprint/8741

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