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Program Evaluation Screening and Treatment Program to Eliminate Hepatitis C in Egypt 19 Mar 2020

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Program Evaluation Screening and Treatment Program to Eliminate Hepatitis C in Egypt 19 Mar 2020 The new england journal of medicine Special Report Screening and Treatment Program to Eliminate Hepatitis C in Egypt Imam Waked, M.D., Gamal Esmat, M.D., Aisha Elsharkawy, M.D., Magdy El‑Serafy, M.D., Wael Abdel‑Razek, M.D., Reham Ghalab, M.Sc., Galal Elshishiney, M.Sc., Aysam Salah, B.Sc., Soad Abdel Megid, M.Sc., Khaled Kabil, M.Sc., Manal H. El‑Sayed, M.D., Hany Dabbous, M.D., Yehia El Shazly, M.D., Mohamed Abo Sliman, M.Sc., Khalid Abou Hashem, M.Sc., Sayed Abdel Gawad, M.Sc., Nevine El Nahas, B.Sc., Ahmed El Sobky, M.Sc., Sahar El Sonbaty, M.Sc., Hamdy El Tabakh, M.Sc., Ehab Emad, M.Sc., Hany Gemeah, M.Sc., Amal Hashem, M.Sc., Mohamed Hassany, M.D., Naseif Hefnawy, M.Sc., Abdel N. Hemida, M.B., B.Ch., Ayman Khadary, M.B., B.Ch., Kamal Labib, M.B., B.Ch., Faisal Mahmoud, M.B., B.Ch., Said Mamoun, M.Sc., Tamer Marei, M.Sc., Saad Mekky, M.Sc., Alsayeda Meshref, M.Sc., Alaa Othman, M.Sc., Omnia Ragab, M.Sc., Elhag Ramadan, M.Sc., Ahmed Rehan, M.Sc., Tarek Saad, Ph.D., Ramy Saeed, M.Sc., Mohamed Sharshar, M.Sc., Hesham Shawky, M.Sc., Mohamed Shawky, M.Sc., Wael Shehata, B.Sc., Hanaa Soror, M.Sc., Mohsen Taha, M.Sc., Mahmoud Talha, M.Sc., Adel Tealaab, M.Sc., Mohamed Zein, M.D., Alaa Hashish, M.P.H., Ahmed Cordie, M.D., Yasser Omar, M.D., Ehab Kamal, M.D., Islam Ammar, M.D., Mohamed AbdAlla, M.D., Wafaa El Akel, M.D., Wahid Doss, M.D., and Hala Zaid, M.Sc. Chronic hepatitis C virus (HCV) infection is a ment available for all and to scale up treatment major global health problem affecting 1% of the to millions, as described previously.10 More than world population.1,2 The Sustainable Development 2 million patients were treated by 2018 (repre- Goals that were adopted by the United Nations senting 40% of the total HCV-infected popula- General Assembly in 2015 included combating tion), with cure rates above 90%. However, most viral hepatitis.3 In May 2016, the World Health infected persons remained unidentified. By late Assembly set targets for the elimination of viral 2017, the number of persons with new cases who hepatitis,4 including reaching 90% diagnosis, presented for treatment decreased to less than 80% treatment coverage, and a 65% reduction in 5000 a month (Fig. S1 in the Supplementary Ap- related mortality by 2030.5 pendix, available with the full text of this article When the targets were set, Egypt had the high- at NEJM.org), whereas the model to eliminate the est prevalence of HCV infection, a consequence disease by 2030 required diagnosing and treating of the prevalence of schistosomiasis and its mass 360,000 cases a year.8 treatment by unsafe intravenous injections in the With the decreasing cost of direct-acting anti- 1950s to 1980s.6 In a selected representative virals in Egypt (from $1,650 [in U.S. dollars] for sample of the Egyptian population between 15 12 weeks of sofosbuvir plus daclatasvir in early and 59 years of age in the Demographic and 2015 to $85 for local generics in 2018), treatment Health Survey (DHS) of 2015, approximately of more patients and accelerated disease elimi- 10% of persons were seropositive for HCV anti- nation became possible. In early 2018, the Egyp- bodies and 7% had viremia.7 This amounted to tian government decided to embark on a massive 5.5 million persons with chronic infection, repre- effort to identify and treat all HCV-infected senting a huge health and economic burden.8,9 persons to achieve disease elimination over the With the introduction of effective direct-acting shortest time period possible. Here we describe antiviral agents in 2014 to treat HCV infection, and present the results of the national screening the National Committee for Control of Viral program in Egypt, which show the feasibility of Hepatitis (NCCVH) set a national strategy to screening 50 million people for HCV infection make treatment paid for by the Egyptian govern- to achieve disease elimination. 1166 n engl j med 382;12 nejm.org March 19, 2020 Special Report Methods HCV RNA levels were measured with the use of a real-time quantitative polymerase-chain- Screening Targets reaction (PCR) assay (Cobas AmpliPrep/Cobas The Ministry of Health set goals to screen every- TaqMan HCV Test, Roche Diagnostics). Negotia- one in Egypt 18 years of age or older (a target tions resulted in a cost of $4.80 per test, inclu- population of 62.5 million) within 1 year and to sive of the machines and logistics of setting up provide treatment paid for by the state to all the machines, training the technicians, connect- those with HCV viremia. Planning started in ing the machines to the central database, and May 2018. The country was divided into three transferring the equipment from one phase to screening phases, each to be screened over a the next. PCR machines were set up in one to period of 2 or 3 months. Each phase included three laboratories in each state. Samples that 7 to 11 states, 100 to 150 administrative divisions, were collected in the district referral hospitals and a screening target population of 17.9 million were transported by the supplier to the test labo- to 23.3 million, as detailed in the Supplementary ratories. Appendix (Table S2 and Fig. S2). Screening Screening Sites and Staff Population data at the national, state, and district Screening was conducted in all Ministry of levels were obtained from the Central Agency for Health hospitals; all primary and rural health Public Mobilization and Statistics 2017 national units; Egyptian Health Insurance Organization– census.12,13 The names and national identifica- managed clinics, university hospitals, and mili- tion numbers of persons 18 years of age or older tary and police hospitals; and all youth centers who were registered in each electoral district in all screened areas. Mobile screening teams in were obtained from the National Elections Au- specially outfitted vehicles augmented the screen- thority,14 which automatically registers everyone ing efforts by visiting crowded areas on special 18 years of age or older for voting in the district occasions (mosques for Friday prayers, churches of his or her residence and has a comprehensive for Sunday mass, soccer stadiums during game database of all persons 18 years of age or older. times, and picnic areas and shopping malls on Persons could be screened in any phase and holidays), as well as factories, office buildings, any site, regardless of their residence. Participa- train stations, and subway stations. tion in screening was voluntary, with no finan- Each screening phase had 5800 to 8000 screen- cial or in-kind incentives for participating and ing teams, each including a physician, a nurse, no punitive consequences for not participating. and a data-entry person. Screening sites were Participation in screening was encouraged and open 12 hours per day, 7 days per week. Train- emphasized through a massive national adver- ing started 2 months before screening launch in tisement campaign. Television advertisements ran each phase, in which 800 trainers were taught on all channels throughout the screening period, how to train the screening teams to use the several popular movie and music stars were con- rapid diagnostic test for the detection of HCV tracted for the advertising campaign, and televi- antibodies, to record data and results in the sion and radio talk shows repeatedly had the database, and to set further appointments elec- national HCV screening program as their main tronically. theme. Newspaper advertisements and billboards on many roads were part of the advertising cam- Tests and Prices paign, and millions of text messages were sent The World Health Organization (WHO)–approved to cell phones in each phase. rapid diagnostic test11 (SD Bioline HCV, Abbott) Immediately before screening, the person’s was used. Negotiations led to a price reduction national identification number was electronical- to $0.58 per test, including the test kit, the ly checked against the NCCVH database (which safety lancet, and sharps-disposal containers; includes data on patients previously treated for the cost also included supply-chain management HCV infection with direct-acting antivirals since and delivery to each of 380 central health facili- 2014). Patients who had been previously treated ties, which in turn distributed to the screening were not tested for HCV antibodies. sites. Persons were tested for HCV antibodies with n engl j med 382;12 nejm.org March 19, 2020 1167 The new england journal of medicine the use of a finger-prick rapid diagnostic test, and district levels: the percentage of persons in with results available within 20 minutes. Sero- the target population who participated in screen- positive patients had appointments immediately ing and the prevalence of HCV seropositivity scheduled electronically for a date within 2 to 15 among persons screened for HCV antibodies. days in the closest assigned center for evaluation Confidence intervals for percentages were cal- and treatment. At the center, patients received culated with the use of the Wilson method in clinical evaluation, underwent abdominal ultra- R software, version 3.6.1. sonography, and had blood drawn for HCV RNA Results in each state and district were com- and liver-function tests, as detailed in the Sup- pared and analyzed according to sex, age group, plementary Appendix. Patients returned for re- and urban or rural residence. State-level preva- sults after 5 days, and treatment was prescribed lence was compared with that in the most recent for those with viremia. All patients were treated nationwide survey, the 2015 DHS.7 Different with sofosbuvir (400 mg daily) plus daclatasvir geographic regions as detailed in Table S1 were (60 mg daily) with or without ribavirin for a compared.
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