Egypt stands out as one of the countries hosting the highest prevalence of hepatitis C worldwide with an overall 9.8 per cent between the ages of 15 and 55 having an active viral infection. These figures were reported according to the Egyptian Demographic Survey of 2008. A new survey is expected to take place next month, March 2014.
News of a recent breakthrough in the treatment of the virus thus raised high hopes among Egyptians, only to give way to a severe let-down once it was realised that the treatment may be way beyond what the country can afford. It didn’t help that, in the midst of the widespread disappointment, rumours circulated that Egypt might have received the new medication at an affordable price had a former cabinet minister allowed the discoverer to conduct clinical tests on Egyptian patients.
According to Manal Hamdy al-Sayed, Professor of Paediatrics at Ain Shams University, member of Egyptian National Committee for Control of Viral Hepatitis and supervisor of the National Strategy for Control of Viral Hepatitis at the Ministry of Health, the only approved treatment for hepatitis C until 2013 was interferon therapy, in addition to Ribavirin capsules. Last December, the first two oral medications were approved by the Food and Drug Administration (FDA) in the United States for treatment of hepatitis C with or without Interferon. Both have proved efficacy and safety with a cure rate of more than 90 per cent.
The first approved drug, Simeprevir, was approved last December but only for use in hepatitis C genotype 1; while the prevalent type in Egypt is genotype 4. Currently, studies are being conducted with the same drug on genotype 4 patients in Europe and the results will be submitted for approval by the European Medicines Agency (EMEA) next May (2014). Egypt is preparing a clinical trial with this medication, expected to start within the next few months.
Two days later, on 6 December 2013, the FDA approved the second drug, Sofosbuvir, spanning all hepatitis C genotypes. This medication is suitable for all types of hepatitis C and can also be used with or without Interferon. The inventor of this medication, Professor Raymond Schinazi, is an Egyptian-Italian-American scientist who has discovered several molecules and medications effective for treatment of HIV/AIDS and hepatitis B. A few months after his breakthrough discovery, he sold the molecule and his original company Pharmasset to the current owner of the medication.
Several Egyptian newspapers harshly criticised Nadia Zakhary, former Minister of Scientific Research, claiming that her refusal to perform clinical tests concerning the new treatment for hepatitis C as requested by Professor Schinazi had deprived Egypt of the opportunity to get the medication at an affordable price. Dr Abdel-Hamid Abaza, assistant to the Health Minister, told Watani that the allegation was unfounded and the entire matter had been overblown by the media.
“When Professor Schinazi asked Dr Zakhary to approve the trials, she asked him to present the approval of the FDA. At that time, the new treatment was still in the clinical trial stage and was not approved by any internationally known body; the treatment was still identified by its code name and did not even have a scientific name. The standard procedure adopted worldwide is never to approve any treatment or allow its trial on animals or humans unless it is approved by the FDA. Therefore, Dr Zakhary had every right to reject Dr Schinazi’s request. The treatment was eventually approved by the FDA in December 2013.”
Watani asked if any research was being conducted to test the efficiency of the new treatment on the Egyptian strain of the hepatitis C virus? Dr Sayed said Egypt began clinical trials with the new medication during the second half of 2013 in three scientific research centres: the National Liver Institute in Cairo, Cairo University and Mansoura University. The final results of the study will be presented within the next three months, but preliminary results show high efficacy and safety of the medication in treatment of hepatitis C among the Egyptian population. However, the medication had been priced in the USA at an unaffordable level, with a month’s course costing USD28,000 and the course of treatment lasting from three to eight months.
So would it be in any way possible for Egypt to obtain the medicine at a reduced price, as hinted by the Ministry of Health?
Dr Sayed said the National Committee for Control of Viral Hepatitis and the Egyptian Health Ministry were leading negotiations with the producers to obtain the medication for Egyptian patients at an affordable price, to be followed by fast track registration. The World Health Organisation (WHO) is supporting the Egyptian government in its negotiations with the various pharmaceutical corporates. The long term experience of international organisations in support of the African continent to reduce the price of medication for HIV/AIDS could be replicated and similarly applied in our country.
Dr Abaza, however, does not expect that any medication will be available at an affordable price in the near future, since it is monopolised by four or five international drug manufacturing companies which demand very high prices. Nevertheless, the Ministry of Health is doing its best to reduce or subsidise the price. Even had Egypt approved trials of the new treatment before it was approved from the FDA it would not have been possible to obtain it at a reduced price because the discoverer of the treatment does not have the authority to set its price. This usually falls to the manufacturing company, and with the millions of dollars spent on research, tests and approval of the new treatment, it is normal for any new drug to command a very high price when it hits the market. Egypt’s only hope is that the WHO is able to subsidise the new treatment.
Prevention better than cure
The unquestionable wisdom being that prevention is better than cure, Egypt is embarking on a national plan to curb the spread of the disease.
According to Dr Sayed, Egypt is currently developing a full strategic costed implementation plan to curb the spread of viral hepatitis in the community, in partnership with WHO, the Centre for Disease Control (Atlanta, US) and the Pasteur Institute. The action plan was finalised 15 months ago, but further progress was delayed by the political turmoil. The plan addresses all components relating to prevention of viral hepatitis including surveillance, infection control, blood safety, vaccination, communication and education, screening, care and treatment. A communication development plan supported by UNICEF will be presented for funding within the next month. It is expected that in the next few months this plan will be presented to international and national donor agencies for funding and implementation support.
The sheer numbers, however, ring a note of hope. Dr Abaza told Watani that whereas the total figure of hepatitis C in Egypt is an appalling 9.8 per cent, the figure among Egyptians aged 20 – 45 is 4.6 per cent, meaning that the prevalence of the disease among younger generations was less. This comes as no surprise, he says, because the largest wave of the spread of the disease was during the times when no disposable needles were used in injections and awareness of the disease and methods of its spread was minimal among the public. “This has changed today,” Dr Abaza says. “And if the numbers are anything to go by, things are looking up.”
23 February 2014