Hepatitis C Treatment
"At the age of 27, I went to England with my spouse to undertake a master's degree. When you arrive there, you take routine medical tests. That's how I accidentally found out that I am infected with the hepatitis C virus. It is a strange feeling when you are told that you are ill. On the one hand, you do not have any symptoms, but on the other, having learned from a doctor what happens in your body, this information starts working against you psychologically. It gradually causes quite serious changes, first in your emotional state and then in your physiological condition. You come to understand that this is not as simple a process as you might imagine. The disease was quite developed. According to doctors, I had lived with hepatitis C for 15 years already. The stigma of being infected was so strong that I did not want to speak about my disease with anyone. I knew that once you start speaking about hepatitis C, you are instantly considered a drug abuser. This means that the career for which you have been working so hard for so long, will be ruined overnight," recounts Irakli Imnaishvili, a producer at BBC Worldwide. Today, Irakli leads a non-governmental organization, the Union of Patients with Hepatitis C, which specializes in problems related to hepatitis C.
According to the World Health Organization (WHO), approximately 150 million people suffer from the chronic form of hepatitis C worldwide. From three to four million new patients join their ranks annually. According to data from 2002, some 200,000 people in Georgia are infected with the hepatitis C virus. This amounts to 6.7% of the adult population (research of the John Hopkins AIDS Center, 2002).
According to Dr. Maia Butsashvili, a specialist in infectious diseases, some 15% of patients infected with the hepatitis C virus, get cured without any treatment while the remaining 85% develop a chronic infection which may cause cirrhosis and liver cancer. The majority of patients with hepatitis C do not develop any symptoms and have no complaints until cirrhosis and liver cancer arise. A much smaller segment of such patients develop such symptoms as fatigue, fever, decreased appetites, nausea, muscle or joint pains, depression... The symptoms are so nonspecific that it is impossible to clinically diagnose hepatitis C. The only way of diagnosing it is in a laboratory.
Today, owing to antiviral medication, hepatitis C can be cured, though the chance of being cured ranges between 70% and 85% depending on the genotype of the virus. The cost of a comprehensive diagnosis necessary to determine the best course of treatment ranges between 1,000 and 1,600 GEL on average. The duration of treatment depends on the genotype of the hepatitis C virus and ranges between six months and one year. The virus genotype also determines whether a patient needs a course of treatment involving two or three medicines. The price of the same medicine varies across the world. Currently, the available hepatitis C antiviral medicines in Georgia are among the most expensive in the world. A course of treatment with two medicines costs between 10,000 to 20,000 GEL, depending on the length of the treatment; whilst the treatment involving three medicines costs from between 45,000 to 100,000 GEL. In Georgia such treatments have been undertaken by a little more than 2,000 patients at their own expense so far. This was the situation concerning hepatitis C treatments before the government recently interfered in this area.
In September 2013, the then Prime Minister of Georgia, Bidzina Ivanishvili, talked about the issue of financing the treatment of hepatitis C: "We took a decision on the treatment of hepatitis C. We managed to purchase very expensive medication at cheaper prices. The treatment will be free of charge, not only for inmates in prisons – we will soon make such an expensive treatment free in Georgia." Regardless of the prime minister's statement, a tender conducted in September-October 2013, which was announced for the purchase of medication for patients in penitentiary institutions, ended without result.
The tender was conducted again in December 2013 and resulted in a new price of medication being offered. A one year course of treatment with two medicines will cost 7,500 GEL, whilst the cost of a six-month treatment will be halved accordingly – to 3,750 GEL. With the price established through the recent tender, from 2014, Georgia will be the second cheapest place in the world, after Egypt, to receive medication for treating hepatitis C.
Beginning in 2014, with the medication purchased by the state, some 1,000 inmates will undertake a course of treatment over a period of two years. The changes will affect the civil sector too. According to the terms of the tender, the price paid by the state for the medication will extend to 10,000 citizens over a period of two years. Until now, tenders of the Global Fund have failed to ensure any drop in prices for retail sale and have remained high for the civil sector.
Thus far, Georgia has only financed the treatment of those patients who, along with hepatitis C, also suffered from HIV/AIDS. This program, which is fully financed by the Global Fund, has been implemented since 2011. The Minister of Health Care of Georgia, Davit Sergeenko, said: "it is planned to identify a 'new involvement group' which will be financed from the budget." According to the deputy Penitentiary Minister, Archil Talakvadze, "apart from the beneficiaries of the Global Fund, several tens of inmates who appealed to national or international courts have also been financed so far. These were instances where the case hearings were not completed, but as the state anticipated that it would lose those cases, it agreed to finance the treatment."
Archil Talakvadze singled out four cases of Georgian inmates suffering from hepatitis C which were heard by the European Court of Human Rights in Strasbourg. The court subsequently found that Article 3 of the Convention on Human Rights had been violated and, as a result, the court imposed concrete obligations on the state that implied both the delivery of antiviral treatment at the cost of the state and a compensation to be paid. Moreover, up to 80 other cases were also in the process of being heard by the Strasburg court. This would have meant that if the situation had not changed Georgia would have lost an additional 80 cases within a maximum of two years.
Although the price established through the tender, which will extend to 100,000 patients, is notably lower than that which has existed to date, it will still remain unobtainable for the majority of patients. One of the stimuli for lowering prices, however, is competition. Marina Chokheli, the coordinator of the Harm Reduction Direction at the Open Society Georgia Foundation (OSGF) spoke about the importance of the registration of a recently developed Egyptian medication. According to her: "so far, there are only two pharmaceutical companies in the world and in Georgia [that provide hepatitis C medicine] – Roche and Merck. These companies basically operate in agreement and therefore the difference in their prices is at maximum one or two US dollars. The appearance of a new company on the market creates competition, thereby leading to a notable decrease in price. In this regard, the example of Egypt is interesting: this country created the same medication from another biological material. This medication first appeared in 2006 and cost about 1,800 USD. In the very same year, the price of the medicines of the Roche and Merck pharmaceutical companies dropped below 2,000 USD in Egypt." (These prices correspond to a 48-week course of treatment.)
The Egyptian medication was not registered in Georgia. As the Minister of Labor, Health and Social Affairs of Georgia, Davit Sergeenko, explains: "Georgia does not have patients diagnosed with genotype IV of the virus, whereas the Egyptian medicine is effective for this group alone. Consequently, it makes no practical sense to register or purchase this medicine."
owever, Dr. Maia Butsashvili, an infectious disease specialist, says that "the grounds of refusal by the Drug Agency to register the Egyptian medicine is that clinical tests were mainly undertaken on genotype IV of the virus, while in Georgia the most commonly spread genotypes are I, II and III; therefore, the tests were regarded as insufficient. A segment of doctors advocated for registering the medicine for the treatment of genotype IV and then allowing doctors to take personal decisions about the use of it to treat other genotypes." Mari Chokheil of OSFG adds that "in January, the release of a new study is expected, which will show the differences between these medications. However, various studies have already proved that all medicines are equally effective for various genotypes; the difference is only in the duration of treatment."
Yet another problematic issue related to hepatitis C is the prevention of the disease. Since the hepatitis C virus is primarily spread by blood-to-blood contact it is absolutely necessary to pay close attention to the observance of norms for the sterilization of equipment in medical institutions and beauty salons.
However, the supervising sanitary inspectorate responsible for controlling dentists' clinics and beauty salons, was abolished in 2006 and the state now has no body in charge of inspecting compliance with sterilization norms. Health Minister Davit Sergeenko has spoken about the changes to be implemented in the nearest future: "a decree on heightening the control on infections at dentists' clinics has already been taken. Moreover, a new program of "safe blood" will enter into force shortly, which will increase controls against infections in blood banks and will radically decrease the cases of contracting infections from blood products. At this stage, the Health Care Ministry has already completed its work on improving the sterilization of surgery instruments and medical waste treatment and a new regulation will enter into force in the nearest future."
Irakli Imnaishvili, who talks about inappropriate sterilization in medical institutions and beauty salons, cites the example of Egypt: "In Egypt, some 60,000 patients undertake treatment that is fully financed by the government; in parallel, however, 100,000 newly infected patients emerge annually. This means that Egypt is regressing instead of maintaining its existing level. This happens because of the absence of prevention. The key cause of hepatitis C is a very low standard of health care in the country. Prevention appears to be a very difficult task. Georgia has not taken any effective step in this direction. I will rank this as the number one problem! Also, informing society is very important. For me, more problematic than the availability [of treatment] is the inadequate information for society. I do not say that we must ignore the availability of treatment, but we have an informational vacuum. There are lots of myths spread around about hepatitis C. Social attitudes are of utmost importance and they are most often changed as a result of an adequately informed society. For example, if you know that the disease is not spread by a handshake and also know how one may become infected with the hepatitis C virus, your attitude towards a person with this disease becomes appropriate. It is also important for both patients and wider society to realize the degree of damage that alcohol and the Georgian way of life brings to those infected with hepatitis C."