Treatment of hepatitis C in primary health care in the country of Georgia

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BACKGROUND AND AIMS

Georgia is a small country with a population of 3.7 million and high hepatitis C virus (HCV) prevalence. ¹ According to the national survey conducted in 2015, 5.4% of all adults in the country were living with HCV infection. ²

In April 2015, with technical assistance from the US Centers for Disease Control and Prevention (CDC) and support from Gilead Sciences, Georgia launched the world's first national hepatitis C elimination program. Key strategies include nationwide HCV screening, active case finding, linkage to care, decentralized care, and provision of treatment for all persons with HCV infection, along with effective prevention interventions. The HCV elimination program aimed to achieve the following targets by 2020: (1) diagnose 90% of HCV‐infected persons, (2) treat 95% of those diagnosed, and (3) cure 95% of those treated. ³ , ⁴ , ⁵ The program was started in four clinics of Georgia's capital, Tbilisi. The first direct‐acting antiviral medication provided by Gilead Sciences was sofosbuvir, which was used in combination with ribavirin with or without pegylated interferon; sofosbuvir/ledipasvir and sofosbuvir/velpatasvir were introduced in Georgia in 2016 and 2018, respectively. Within the program, all patients have access to HCV antibody testing, and to confirm current HCV infection, HCV RNA or core antigen testing. HCV genotyping was performed for all patients who tested positive for HCV RNA before availability of sofosbuvir/velpatasvir, a pangenotypic regimen, in the country. Noninvasive tests used for assessment of the degree of liver fibrosis include Fibrosis‐4 (FIB‐4) score ⁶ and ultrasound or transient elastography, which measures liver stiffness. ⁷ , ⁸

By October 31, 2021, more than 76,000 persons initiated treatment, achieving >98% cure rates. Patient enrollment in HCV treatment sharply increased in 2016 (Figure 1). However, the numbers treated for HCV subsequently slowed because of deficiencies in HCV testing and linkage to care. In 2018, to overcome existing challenges, Georgia decentralized services by integrating HCV screening and treatment in primary health care centers (PHCs). ⁹

FIGURE 1.

Patients initiating treatment, Georgia HCV elimination program, April 2015 to October 2021. Green bars represent patients initiating treatment; red line represents cumulative initiated treatment.

METHODS

From May 2018 through July 2021, a total of 10 PHCs provided HCV care services throughout the country. The integrated model was based on a “one‐stop‐shop” approach, by which patients received all HCV screening and care services in selected PHCs. Treatment‐naive patients with no or mild fibrosis (FIB‐4 score < 1.45) received care at PHCs and underwent examinations as per simplified diagnostic (Figure 2) and treatment monitoring (Figure 3) algorithm, while persons with FIB‐4 score > 1.45 were referred to specialized clinics. Patients received sofosbuvir/ledipasvir or sofosbuvir/velpatasvir for 12 weeks. Sustained virological response (SVR) was defined as undetectable HCV RNA 12 to 24 weeks after the end of therapy. The Extension for Community Health care Outcomes (ECHO) telemedicine model was used to train and support primary health care providers. Regular teleECHO videoconferencing was conducted to provide primary care providers with advice and clinical mentoring.

FIGURE 2.

Pretreatment evaluation.

FIGURE 3.

Monitoring algorithm during antiviral therapy. Asterisks indicate only for patients receiving ribavirin‐containing regimens.

RESULTS

Among persons diagnosed with current HCV infection, 1454 were evaluated for FIB‐4 score. Of these, 944 (64.9%) had FIB‐4 score < 1.45. A total of 954 patients initiated treatment in the PHCs. Of these, 883 (92.6%) patients completed treatment. Of 864 patients eligible for SVR testing, 696 had been tested at the time of analysis, and 683 achieved SVR (98.1% cure rate) (Figure 4).

FIGURE 4.

HCV care cascade in PHCs, July 31, 2021.

DISCUSSION

Along with successes, Georgia faces serious challenges on the road to elimination of hepatitis C. Despite wide‐scale HCV screening, treatment uptake has declined. ¹⁰ One of the main reasons for low HCV treatment rates are barriers in accessing care and treatment services. Among persons tested positive for HCV antibodies in Georgia, 28.5% did not get confirmatory testing for HCV infection. ¹⁰ Linkage to care is a problem globally. For example, in Australia, only 47% of HCV antibody‐positive persons received HCV RNA testing. ¹¹ Decentralization has been shown to be beneficial in international settings. ¹² The Australian model of hepatitis C decentralized care has shown excellent outcomes of HCV treatment. ¹³ Because of substantial simplification in treatment regimens and evaluation, effective HCV treatment by primary care providers is realistic. ¹⁴ , ¹⁵ The decentralization process was started in Georgia in May 2018, and integrated models are available in each district of Georgia currently. Regular ECHO teleconferencing, availability of necessary laboratory testing, and medications at each site were critical factors for a successful treatment program at PHCs.

There are several limitations in this study. First, data collection was incomplete. Data do not include subanalysis of hepatitis C care results stratified by age, gender, and rural/urban PHCs. Second, integration of HCV treatment with primary health care services in Georgia involved only a limited number of PHCs. Our study reported the effectiveness of a simplified HCV treatment model in PHCs. The nationwide expansion of an integrated, decentralized model of HCV treatment within PHCs is planned. The decentralization of HCV care in primary care settings throughout the country will improve linkage to HCV care, close the gaps in HCV cascade, and accelerate progress toward HCV elimination in Georgia.

FUNDING INFORMATION

The research was supported by GPHA (Grant 04583). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of Gilead Sciences.

CONFLICT OF INTEREST

Nothing to report.

Dolmazashvili E, Sharvadze L, Abutidze A, Chkhartishvili N, Todua M, Adamia E, et al. Treatment of hepatitis C in primary health care in the country of Georgia. Clinical Liver Disease. 2022;20:175–178. 10.1002/cld.1260