Thursday, July 20, 2017

Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients

Saudi J Gastroenterol [serial online] 2017 [cited 2017 Jul 20];23:263-4. Available from:

Towards supporting greater and lower cost access to direct acting antiviral treatment for hepatitis C for all patients

Said A Al-Busafi1, Heba Omar2

It is with great interest that we read the Saudi Association for the Study of Liver diseases and Transplantation (SASLT) position statement [1] and guidelines [2] on direct-acting antiviral agents (DAAs) for the treatment of hepatitis C virus (HCV) infection. The position statement and the guidelines, which were clearly influenced by the limited availability of highly priced DAAs, recommend that HCV treatment should be prioritized to patients at higher risk for developing HCV-related complications.

The introduction of the curative DAAs to the global market caused worldwide celebration because it is expected to save millions of lives and control if not eliminate one of the major infectious disease worldwide.[3] Unfortunately, for the majority of HCV patients, these costly medications are not readily available, accessible, or affordable even for those in the developed countries.[3] This is likely going to affect many countries in their ability to minimize the burden of this disease.[4]

On the other hand, generic DAAs (sofosbuvir, ledipasvir, and daclatasvir) are being produced in India and other countries with permission of the concerned pharmaceutical agencies and priced less than 1% of their current actual price in USA and Europe. The evidence for the clinical safety and efficacy of these generics is compelling including the recent interim results from international REDEMPTION trial presented by Freeman et al.[5] The results of this trial, which was supported by the European Association for the Study of the Liver (EASL), are important in indicating that generic DAAs are highly effective and safe comparable to those reported in clinical trials of branded DAAs. Another abstract presented by Hill et al. at the same meeting showed that the active pharmaceutical ingredient for the combination of sofosbuvir and daclatasvir was approximately $200 for 12 weeks' course of treatment per patient.[6]

Oman, with an estimated HCV prevalence of 1%, is one such country where access to those important agents is also limited.[7] This has led many of our patients to self-import these drugs from India giving them hope instead of waiting for years to be treated from this debilitating disease.

At the Sultan Qaboos University Hospital, using the EASL 2016 guidelines,[8] we have treated 58 HCV patients [28% genotype 3, 26% cirrhotic with 40% of them decompensated, and 3% severe chronic kidney disease (CKD)] with generic DAAs including (sofosbuvir, ledipasvir, and daclatasvir). Sustained virological response was achieved in 57 patients (98%), the remaining one patient with severe CKD discontinued treatment due to worsening renal function. All patients with decompensated cirrhosis were delisted from transplantation.

Therefore, healthcare leaders and policy makers at the national and international level should adopt strategies to ensure that these DAAs are made available and are accessible and affordable for all in need.
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Alghamdi AS, Alqutub A, Abaalkhail F, Sanai FM, Alghamdi H, Altraif I, et al. SASLT position statement on the direct-acting antiviral agents for the treatment of hepatitis C virus infection. Saudi J Gastroenterol 2015;21:60-3.
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Alghamdi AS, Alghamdi M, Sanai FM, Alghamdi H, Aba-Alkhail F, Alswat K, et al. SASLT Guidelines: Update in Treatment of Hepatitis C Virus Infection. Saudi J Gastroenterol 2016;22(Suppl 2):S25-S57.
Freeman JA, Hill A. The use of generic medications for hepatitis C. Liver Int 2016;36:929-32.
Edwards DJ, Coppens DG, Prasad TL, Rook LA, Iyer JK. Access to hepatitis C medicine. Bull World Health Organ 2015;93:799-805.
Freeman J, Sallie R, Kennedy A, Hieu PT, Jeffreys G, Hill AM. High sustained virological response rates using generic Direct Acting Antiviral treatment for Hepatitis C, imported into Australia. J Hepatol 2016;2:S209.
Hill A, Gotham D, Fortunak J. Significant Reductions in Costs of Generic Production of Sofosbuvir and Daclatasvir for Hepatitis C Treatment in Low- and Middle-Income Countries. J Hepatol 2016;2:S209.
Alnaqdy A, Alfahdi A, Alkobaisi M, Kaminski GZ. Prevalence of autoantibodies in patients with hepatitis C virus infection in Oman. Ann Saudi Med 2003;23:127-31.
European Association of the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2016. J Hepatol 2017;66:153-94.  

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