The Balm of Gilead for the Georgian Nation
30 April, 2015
The Balm of Gilead for the Georgian Nation
Balm of Gilead – Biblical Ailment that was believed to cure entire nations

“Is there no balm in Gilead? Is there no physician there? Why then is there no healing for the wound of my people?”
Jeremiah 8:22

The project will begin with Gilead providing enough Sovaldi to treat 5,000 people and later increasing the amount to allow treatment of 20,000 patients per year. Once Georgia approves the second drug, Harvoni, Gilead will incorporate it into the project as well.

Hepatitis C is an extremely resilient disease. From diagnosis to the final stages of treatment, it stubbornly refuses to give ground. Even after the therapy is over, not many patients can be certain about being fully cured. From 150 to 200 million people worldwide are suffering from this disease, and three to four million are infected each year. Treatment is costly, prognoses are far from optimistic and outcomes are largely unpredgeotv.geictable.
However, it seems that Georgians suffering from this disease will be able breathe a sigh of relief very soon -- thanks to the relentless efforts of Deputy Interior Minister Archil Talakvadze, Health Minister David Sergeenko and former Deputy Health Minister Mariam Jashi. Following lengthy negotiations between Georgia’s Ministry of Health and the American pharmaceutical company Gilead Sciences, an unprecedented project is about to be unfolded in the country. Sovaldi and Harvoni, two newly created drugs with an astounding treatment success rate of 90+ percent, will be distributed to hepatitis C patients for free.
This will be the largest field test of the two new medicines. There are roughly 120,000 people infected with the virus in Georgia, and as Gilead Sciences representatives claim, a massive real-world effort is going to be far more convincing than any clinical studies.
The project will begin with Gilead providing enough Sovaldi to treat 5,000 people and later increasing the amount to allow treatment of 20,000 patients per year. Once Georgia approves the second drug, Harvoni, Gilead will incorporate it into the project as well. Both the Ministry of Health and the pharmaceutical company claim their goal is to “eradicate the virus from Georgia once and for all.”

“Gilead Sciences, the company that will be distributing the medication, is aiming to show that they not only provide reliable results in clinical testing conditions, but, if applied by a healthcare system correctly, they can completely rid the country of hepatitis C. This is the main purpose of the project. It will cost Georgia next to nothing, but the whole world will see that the complete elimination of a disease is possible.”

According to Gregg Alton, executive vice president of Gilead Sciences, Georgia was selected as a testing ground for their new medicines for several reasons. Aside from an extremely high percentage of people infected with hepatitis C (third highest in the world behind Egypt and Mongolia), Georgia also has a high variation in viral strains and types of patients alike. Georgia’s efficient viral screening systems and its moderately small population of 5 million were also a major factor in being selected for the project.
geotv.geHowever, this promising initiative leaves many people skeptical. Free cheese is only found in mousetraps, skeptics say. It would be unprofessional to dismiss their suspicions out of hand, and Gilead Sciences has so far left many questions unanswered. For example, no one knows how the company intends to prevent and combat smuggling and profiteering of the insanely expensive medicine. The precise role of the Georgian government in carrying the initiative out is also somewhat vague. Georgian Journal recently contacted Gilead Sciences in order to clear the air. Their replies will be offered to our readers in the next issue.
As ex-PM Bidzina Ivanishvili claims, the original idea of this initiative belongs to Archil Talakvadze, Deputy Interior Minister. A test version of the project he proposed was first implemented in one of Georgia’s prisons. The results were successful and inmates are provided with free medication to this day. In 2013-2014, Georgia received a massive 60 percent discount on medication thanks to successful negotiations with Roche and Merck pharmaceutical companies. This made us a country with the second cheapest medication in the world, Egypt being the first.
Georgian Journal met with Mr. Talak­vadze, a man who firmly insists that medication and therapy should be rights, not privileges, to find out more about the upcoming events:

–The elimination program was drafted and implemented under Minister Sergeenko’s careful supervision. He also was the one who conducted negotiations, so I think that the success should be attributed to him rather than me. The upcoming project is significant not only from a commercial, but also from an epidemiological point of view – Gilead Sciences, the company that will be distributing the medicines in question, is aiming to show that they not only provide reliable results in clinical testing conditions, but, if applied by a healthcare system correctly, they can completely rid the country of hepatitis C. This is the main purpose of the project. It will cost Georgia next to nothing, but the whole world will see that the complete elimination of a disease is possible.

– You must be quite proud to be the author of the original idea and to see what it has evolved into. Do you have any expectations associated with this project?

– I am indeed proud and happy with the fact that Georgia managed to consolidate itself in order to achieve success. We have shown that the government can unite with the people and the scientific community to achieve a near-impossible goal that many other, larger and stronger states, have failed to. For me, this project will always remain a milestone and a foundation to base future projects on.

Eligibility Criteria

At a press conference dedicated to the upcoming project, Deputy Healthcare Minister Valeri Kvaratskhelia revealed the criteria according to which prioritization of the patients for drug distribution will occur. All applicants for treatment should possess documentation (analysis results) confirming their diagnosis of hepatitis C.
Groups of patients given priority include:
Those suffering from compensated cirrhosis;
Those suffering from advanced fibrosis;
Those suffering from decompensated cirrhosis (this includes liver transplant candidates);
Those whose liver became re-infected after transplantation;
Those suffering from clinically significant extrahepatic conditions. These include: type 2 and type 3 mixed cryoglobulinemias (such as vasculitis), proteinuria, nephrotic syndrome, membranoproliferative glomerulonephritis, debilitating asthenia, type 2 diabetes, advanced stages of porphyria cutanea tarda, etc.;
Those suffering from HIV or hepatitis B co-infection.
In addition, all who wish to undergo treatment need to register at any office of the Social Service Agency, where they or their legal representative have to present a document detailing the patient’s health condition (commonly known as a Form NIV-100/a), documents detailing examination(s) of the condition the patient suffers from and a copy of their ID. The patients will also be required to fill out a form that will allow them to select the medical facility at which they wish to be treated.
geotv.ge
According to IDFI, a total of 4,690 cases of hepatitis C infection were confirmed in the years 2013-2014. In comparison to 2013, the amount increased by 644 cases of infection in 2014.
As for HIV, 564 new cases of infection were confirmed in 2014. This is the most since 2006.



Author: Zura Amiranashvili
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