Since its introduction in April 2015, the nation of Georgia’s HCV Elimination Program has shown the potential to rapidly expand HCV care and treatment services, but achieving its 2020 goal of HCV elimination will require improved HCV testing and access to treatment services, according to the CDC’s Morbidity and Mortality Weekly Report.
“The Georgia model program provides valuable lessons for hepatitis C elimination globally, including a key lesson that treatment availability alone is not enough,” Muazzam Nasrullah, MD, MPH, PhD, Medical Officer with CDC’s Division of Viral Hepatitis, told Healio.com/Hepatology. “Eliminating hepatitis C requires a comprehensive approach that includes screening and linkage to care and treatment, high quality diagnostics, surveillance, provision of services to high risk and marginalized populations, and measures to prevent transmission.”
In Georgia, an estimated 150,000 individuals have HCV. Hence in 2015, with technical help from CDC, the nation undertook the world’s first program to eliminate HCV. The program defined elimination as a 90% decrease in HCV prevalence by 2020.
The plan for achieving this goal included identifying infected individuals and connecting them to care and antiviral treatment, which the program offered free of charge through a collaboration with Gilead Sciences.
From April 2015 through December 2016, 27,595 infected people began treatment for HCV infection, 19,778 (71.7%) of whom completed the course of treatment. HCV RNA testing of 6,366 patients 12 or more weeks after the conclusion of treatment revealed that 5,356 (84.1%) had no detectable virus in their blood, suggesting a sustained virologic response (SVR) and HCV cure.
The report stated that in 2015, an estimated 5.4% of Georgia’s population had chronic HCV infection, and nearly two-thirds of these individuals were not aware of their infection. HCV infection was most prevalent in the following populations: men, individuals aged 30 to 59 years, individuals with a history of injection drug use, and those who had received blood products in the past. At the time the program was launched, Georgia’s national guidelines restricted HCV treatment to HCV patients with advanced liver disease.
In June 2016, the country broadened treatment guidelines to include all HCV-infected people, independent of disease severity. Georgia began to offer HCV screenings in January 2015, prior to the introduction of the program, and the country continues to offer free screening services at various locations.
Between January 2015 and December 2016, there were 472,890 HCV screenings, and 50,962 (10.8%) of these were HCV antibody-positive. Screening programs that offered services for injection drug users had the highest rate of HCV antibody-positive tests (45%), while screenings offered to women attending antenatal clinics had the lowest rate of HCV antibody-positivity (0.4%).
For individuals who tested positive for HCV antibody, clinicians used polymerase chain reaction (PCR) to detect HCV RNA to confirm chronic HCV infection. Patients were invited to enroll in the treatment program upon confirmation of chronic HCV infection.
The number of treatment centers increased rapidly under the program, from four centers in April 2015 to 27 centers in December 2016. During that time, 58,233 individuals with positive HCV antibody test results pursued confirmation of chronic HCV through the treatment program. Of the 38,113 patients who initiated a diagnostic evaluation, 30,046 (78.8%) received confirmation of chronic HCV infection. In that group, 27,595 (91.8%) initiated HCV treatment. Men represented 23,062 (83.6%) of individuals initiating treatment; 9,180 of whom were aged 40-49 years.
On average, the number of individuals who began treatment increased 300% between April 2015 to May 2016 (661 per month) and June to December 2016 (2,619 per month), reaching an apex in September 2016 (4,595).
As of December 2016, 19,778 individuals completed treatment, and 6,366 (32.2%) patients subsequently received testing for SVR. Overall, 5,356 (84.1%) patients achieved.
Seventy-five percent of patients received sofosbuvir (without ledipasvir), and 25% received ledipasvir/sofosbuvir-based regimens. In the sofosbuvir-only group, 3,793 (79.5%) achieved SVR, and in the combination group, 1,563 (98.2%) achieved SVR.
Of the 537 patients (1.9%) who did not complete treatment, 371 (69.1%) died of their liver disease or other cause during the treatment course. The remaining 166 (30.1%) halted treatment for other reasons.
“Despite notable progress during the first 20 months of the Georgia HCV elimination program, challenges to Georgia achieving the national targets for HCV elimination by 2020 remain,” the authors wrote. “High-quality screening, innovative linkage-to-care strategies, and cost-effective and simplified diagnostic and treatment regimens are needed.”
By Jennifer Byrne