Process of Elimination

Gilead donates HCV treatments to the country of Georgia

by Larry Buhl

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[dropcap]A[/dropcap]s part of a comprehensive project to eliminate hepatitis C (HCV) from the country, Gilead began providing free hep C regimens containing the company’s breakthrough HCV drug Sovaldi (sofosbuvir) in April.

For Gilead, it’s a chance demonstrate that its products can drastically reduce HCV prevalence and encourage more widespread use of Sovaldi and its eventual successor, Harvoni, which is currently undergoing review in the country of Georgia.

For Georgia, which is estimated to have the third highest prevalence of HCV in the world, according to the World Health Organization, it’s a lifeline to cure estimated hundreds of thousands of affected Georgians who would not have been able to afford the latest HCV treatment.

For hepatitis treatment advocates throughout the world, it’s an opportunity to learn much about how to treat and prevent the virus in especially hard-hit middle-income countries like Georgia.

It’s called the Elimination Project, a collaboration of Ministry of Labor, Health and Social Affairs of Georgia, Gilead, and the U.S. Centers for Disease Control and Prevention (CDC). Beyond the immediate public health impact in Georgia, the plan is to implement a program for HCV elimination and generate valuable data to support similar programs throughout the world.

Right now the Elimination Project is in the first of two phases. Phase one is treating, at no cost to the patient, approximately 5,000 Georgians with advanced liver disease and at the greatest risk of death. Patients are responsible for the cost of screening, which is around $212 USD. The government of Georgia will cover up to seventy percent of that amount for low-income patients. Treatment advocates in Georgia told A&U that in mid-June almost 1,000 patients had started treatment.

Also in phase one, the government of Georgia and the CDC will develop an implementation plan for monitoring and prevention, patient care, and treatment.

Phase two will include the development of a comprehensive elimination plan to guide the implementation of prevention and education programs to stop transmission, broad-based screening to identify persons unaware of their infection, and expansion of medical facilities to increase the number of HCV-infected persons receiving lifesaving care and treatment. This second phase of the program will scale up over time, with a goal of treating up to 20,000 HCV-infected individuals per year.

The CDC will provide technical assistance and consultation for the elimination project, including the implementation of a population-based survey to identify the current prevalence of HCV. These data will be used to measure the success of the project over time. The CDC will also provide assistance and consultation on diagnostics and laboratory quality assurance, treatment guidelines, and program monitoring and evaluation.

A statement released to A&U from Gilead says:

“Georgia’s small population size, high HCV prevalence, and the availability of the necessary diagnostic tests to monitor patients, create an environment that we hope will allow us demonstrate the impact of HCV treatment as part of a larger, national disease elimination plan.”

July 2014’s issue of A&U reported on the surging rate of HIV and hepatitis C (HCV) in Georgia and other former Soviet republics. Paata Sabelshvili, a treatment access activist based in Tbilisi, said the rates of infection were exacerbated by government policies on illegal narcotics. Now he tells A&U that he’s grateful for Gilead’s elimination program, and he hopes the program could indirectly lead to changes in Georgia’s harsh drug laws.

“Right now the [Georgia government’s] opiates substitution program is not sufficient to meet the needs of all who are addicted and I hope the government will scale it up as a result of this elimination program, and change the harsh, restrictive policies that have helped to create this crisis.”

Right now it’s unclear as to what kinds of outreach and prevention policies Georgia’s Ministry of Health will implement, and whether the government will shift from a punishment-based policy for drug addicts to one of harm reduction. Since 2006 Georgia has had “zero tolerance” policy on drug use that shifted prosecution from drug traffickers to users, with no distinction made between possession of drugs for personal use and for trafficking. These policies, Sabelshvili and other activists say, drive drug-dependent people underground, which increase their risk of contracting HIV, HCV, and tuberculosis.

Sabelshvili says he is encouraged by what he’s seen as the government’s new efforts in identifying new places where HCV screening can be made routine, including dentists’ offices and even beauty shops. And he points out Georgia’s new Prime Minister, Irakli Garibashvili, a former business executive, has declared the eradication of hep C as a top priority.

But he adds, “unless the government is able to reach out to all the drug users in the country and develop a total plan for harm reduction, the Elimination Project won’t eliminate [HCV].”


 

Larry Buhl is a radio news reporter, screenwriter, and novelist living in Los Angeles. His podcast on employment issues, “Labor Pains,” can be found at www.laborpainspodcast.com.