|Year : 2019 | Volume
| Issue : 2 | Page : 35-36
Moving toward elimination of hepatitis C in Libya: Shaping tomorrow together
Department of Medicine, Hamad Medical Corporation, College of Medicine, Qatar University, Weill Cornell Medical College, NY/, Qatar
|Date of Web Publication||24-Jun-2019|
Prof. Abdel-Naser Elzouki
Department of Medicine, Hamad General Hospital, HMC, P.O. Box 3050, Doha
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Elzouki AN. Moving toward elimination of hepatitis C in Libya: Shaping tomorrow together. Libyan J Med Sci 2019;3:35-6
Chronic infection with hepatitis C virus (HCV) affects approximately 140 million people worldwide representing around 2%–3% of the world population, and it is estimated that up to half million people die annually from HCV-related disease. HCV infection is the leading cause of liver cirrhosis, hepatocellular carcinoma, and currently, the main indication for liver transplantation in most transplant centers worldwide. The treatment of HCV infection has significantly transformed through recent decades. With the current introduction of HCV direct-acting antiviral (DAA) drugs, the HCV infection is nowadays a curable disease., Over the last few years, numbers of oral DAA regimens approved for the treatment of all genotypes of HCV infection with excellent virologic response rates exceeded 95%. The generic DAA drugs, including sofosbuvir/ledipasvir (Harvoni) fixed-dose combination (SOF/LDV) and SOF/daclatasvir (Daklinza) fixed-dose combination (SOF/DCV), are now widely available in many countries in the Middle East and North Africa region,,,,, and SOF/LDV becoming available in Libya since 2017. In the current issue of Libyan Journal of Medical Sciences, Elhaddad et al. presented the first published results from Libya on the efficacy and safety of this generic SOF/LDV combination in 266 patients with chronic hepatitis C. Their cohort comprised 178 (66.9%) naïve patients and 88 (33.1%) experienced patients, with or without cirrhosis. The predominate genotype was HCV genotype 4 (81.3%) followed by HCV genotype 1 (15.3%) and HCV genotype 2 (3.2%). Sustained virologic response (SVR) at week-12 was observed in 98% of the patients regardless of the presence or absence of cirrhosis or previous treatment status. No clinically significant treatment emergent adverse events and mild adverse effects (i.e., headache, gastrointestinal upset, and dizziness) were reported in only 14.2% of the patients, hepatic decompensation occurred in 5 patients, all were cirrhotic. None of the patients receiving SOF/LDV for 12 weeks needed to have the drug discontinued. The authors concluded that treatment with such imported generic DDA drug achieved a high rate of HCV-RNA undetectability at the end of the treatment and SVR-12 in 98% of patients. A similar results have been recently reported from Egypt, a neighbor country of Libya with predominant HCV genotype 4, in adults and adolescents patients with genotype 4 using SOF/LDV combination with SVR-12 of 98% and 99%, respectively.
With the availability of such generic DAAs, Libyan health authority through the National Center for Disease Control (NCDC) of Libya should launch a universal treatment program to eliminate hepatitis C in the country. Several epidemiologic data on hepatitis C in Libya have been published in the last two decades. Recently, the NCDC of Libya conducted one of the largest general population-based nationwide seroprevalence surveys of hepatitis B (2.2%) and C (1.3%) and their risk factors using a representative sample of >1% of the total Libyan population. Moreover, data on the frequency of HCV genotyping have also been recently reported from Libya and found that HCV genotype 4 and HCV genotype 1 were the most frequent genotypes in the country.,, Patients with HCV genotypes 1 and 4 were classified as “difficult-to-treat” and needed longer duration treatment with interferon-based treatments as compared to HCV genotypes 2 and 3. The later achieved a higher rate of treatment success with interferon-based therapy than patients with HCV genotypes 1 and 4., By the introduction of DDAs, the role of HCV genotyping in the clinical management of hepatitis C has been faded. With the availability of generic SOF/LDV regimen or other regimens such SOF/VEL in Libya, it seems that HCV genotyping can be excluded from the clinical management of HCV infection if ribavirin added to the treatment of all patients with cirrhosis and/or previous history of treatment with pegylated interferon and ribavirin.
To date, no updated recommendations and/or consensus-based National Guideline for the treatment of hepatitis C is exist in Libya. Based on the rapid evolution of the published evidence in literature and also the availability of new treatment regimens, there is a great need to update HCV treatment protocol in Libya. Hopefully, the new treatment regimen of SOF/LDV fixed-dose combination and SOF/DCV fixed-dose combination are becoming widely available as generic drugs for hepatitis C in Libya. In 2015, the United Nations General Assembly adopted the 2030 Agenda for Sustainable Development, which calls on the international community to combat viral hepatitis. In 2016, the World Health Organization set targets for the elimination of as a public health threat by 2030 and provided a global health sector strategy on viral hepatitis including HCV for 2016–2021 that has since be adopted and endorsed by 194 countries. Despite these calls, improving investment in elimination programs has been slow. The global response to HIV has shown us what can be achieved when government, civil society, international organizations, and the private sector work together with a common goal to provide prevention, care, and treatment to those in need. Since hepatitis C is now proven to be a curable disease, such a response is required for this infection in Libya and elsewhere.
Libya is a country with 6,561,050 inhabitants located in North Africa and extends over 1,759,540 km2 (679,362 mi2), making it ranks number 108 in the list of world countries by population. Based on a recent age-adjusted prevalence of HCV of 1.3% found in the nation-based surveillance studies of more than 55,000 individuals carried out in Libya in 2006, an estimation of 85,300 infected patients is anticipated. Moreover, in a recent study of epidemiological characteristics of HCV infection using geospatial analysis in the three regions of Libya (West, East, and South) during 2006–2017, a total of 114,928 newly reported patients with HCV infection during a 10-year period. It has been estimated that around 30,000 patients with the HCV infection were treated for HCV between 2006 and 2017 using pegylated interferon-based therapy and interferon-free therapy (based on the unpublished data). The number of treatment uptakes, therefore, should increase to 15,000 in 2018–2030 annually to achieve the goal of HCV elimination in Libya by 2030. Although we have a long way to eradication of HCV in Libya, the next steps could be including proper planning to patient finding, availability of new treatments with DAAs, and development of HCV prevention strategies.
With wide availability of generic DAAs, the treatment strategy of hepatitis C is now become more feasible and less complex than before and more hepatitis C patients can uptake treatment with active patient finding and integration of HCV treatment for at least naïve patients in primary public health system. Complex cases such as patients with end-stage renal disease on hemodialysis, decompensated cirrhosis, or failure following interferon-free DAAs regimens can be treated in hepatitis/liver-specialized clinics using more intensified regimens.
| References|| |
Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol 2006;45:529-38.
Khullar V, Firpi RJ. Hepatitis C cirrhosis: New perspectives for diagnosis and treatment. World J Hepatol 2015;7:1843-55.
Hesamizadeh K, Sharafi H, Rezaee-Zavareh MS, Behnava B, Alavian SM. Next steps toward eradication of hepatitis C in the era of direct acting antivirals. Hepat Mon 2016;16:e37089.
Walker CM, Grakoui A. Hepatitis C virus: Why do we need a vaccine to prevent a curable persistent infection? Curr Opin Immunol 2015;35:137-43.
Rezaee-Zavareh MS, Hesamizadeh K, Behnava B, Alavian SM, Gholami-Fesharaki M, Sharafi H. Combination of ledipasvir and sofosbuvir for treatment of hepatitis C virus genotype 1 infection: Systematic review and meta-analysis. Ann Hepatol 2017;16:188-97.
Lynch SM, Wu GY. Hepatitis C virus: A review of treatment guidelines, cost-effectiveness, and access to therapy. J Clin Transl Hepatol 2016;4:310-9.
Chen GF, Wei L, Chen J, Duan ZP, Dou XG, Xie Q, et al.
Will sofosbuvir/Ledipasvir (Harvoni) be cost-effective and affordable for Chinese patients infected with hepatitis C virus? An economic analysis using real-world data. PLoS One 2016;11:e0155934.
Akin M, Buldukoglu OC, Adanir H, Suleymanlar I, Dincer D, Yildirim B. Effectiveness and safety of sofosbuvir/ledipasvir±ribavirin treatment in liver and/or renal transplant patients with chronic hepatitis C: A single-center experience. SAGE Open Med 2018;6:2050312118781416.
Cavoli GL, Schillaci O, Zagarrigo C, Servillo F, Li Cavoli TV, Palmeri M, et al.
The efficacy and safety of sofosbuvir/ledipasvir therapy in patients on long-term hemodialysis with hepatitis C virus infection. Indian J Nephrol 2018;28:175-6.
Abozeid M, Alsebaey A, Abdelsameea E, Othman W, Elhelbawy M, Rgab A, et al.
High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C. Int J Infect Dis 2018;75:109-14.
Tang L, Kamat M, Shukla A, Vora M, Kalal C, Kottilil S, et al.
Comparative antiviral efficacy of generic sofosbuvir versus brand name sofosbuvir with ribavirin for the treatment of hepatitis C. Interdiscip Perspect Infect Dis 2018;2018:9124604.
Elhaddad AB, Nouh FA, Elhassi A, Taher S, Daw E. Efficacy and tolerability of ledipasvir/sofosbuvir on chronic hepatitis C virus patients attending viral hepatitis clinic at Benghazi medical center. Libyan J Med Sci 2019;3:38-41. [Full text]
Shiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, et al.
Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: Results from a randomised phase III study in egypt. Gut 2019;68:721-8.
El-Khayat HR, Kamal EM, El-Sayed MH, El-Shabrawi M, Ayoub H, RizK A, et al.
The effectiveness and safety of ledipasvir plus sofosbuvir in adolescents with chronic hepatitis C virus genotype 4 infection: A real-world experience. Aliment Pharmacol Ther 2018;47:838-44.
Elzouki AN, Smeo MN, Sammud M, Elahmer O, Daw M, Furarah A, et al.
Prevalence of hepatitis B and C virus infections and their related risk factors in Libya: A national seroepidemiological survey. East Mediterr Health J 2013;19:589-99.
Mahmud S, Al-Kanaani Z, Chemaitelly H, Chaabna K, Kouyoumjian SP, Abu-Raddad LJ. Hepatitis C virus genotypes in the Middle East and North Africa: Distribution, diversity, and patterns. J Med Virol 2018;90:131-41.
Elzuoki AN, Elzouki I, Albarassi S, Gammo M, Burwaiss A. Hepatitis C genotypes in Libya: Correlation with patients' characteristics, level of viremia, and degree of liver fibrosis. Oman Med J 2017;32:409-16.
Daw MA, El-Bouzedi A, Dau AA. Geographic distribution of HCV genotypes in Libya and analysis of risk factors involved in their transmission. BMC Res Notes 2015;8:367.
Yee BE, Nguyen NH, Zhang B, Lin D, Vutien P, Wong CR, et al.
Sustained virological response and its treatment predictors in hepatitis C virus genotype 4 compared to genotypes 1, 2, and 3: A meta-analysis. BMJ Open Gastroenterol 2015;2:e000049.
Coppola N, Pisaturo M, Tonziello G, Sagnelli C, Sagnelli E, Angelillo IF. Efficacy of pegylated interferon α-2a and α-2b in patients with genotype 1 chronic hepatitis C: A meta-analysis. BMC Infect Dis 2012;12:357.
Alvian SM, Sharafi H. Update on recommendations for the clinical management of hepatitis C in Iran 2017. Hepat Mon 2017;17:e63956.
Daw MA, Buktir Ali LA, Daw AM, Sifennasr NE, Dau AA, Agnan MM, et al.
The geographic variation and spatiotemporal distribution of hepatitis C virus infection in Libya: 2007-2016. BMC Infect Dis 2018;18:594.