Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia

Tsertsvadze, Tengiz; Gamkrelidze, Amiran; Nasrullah, Muazzam; Sharvadze, Lali; Morgan, J.; Gvinjilia, Lia; Kamkamidze, George; Metreveli, David; Kerashvili, Vakhtang; Butsashvili, Maia; Zarkua, Jaba; Chkhartishvili, Nikoloz; Abutidze, Akaki; Baliashvili, Davit; Kvaratskhelia, Valeri; Averhoff, Francisco

doi:10.1016/s0168-8278(17)31978-5

Cited by 3 publications

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“…1,661 (29) 214 (10) 47 (17) 127 (13) 125 (18) 59 ( 9) 117 ( 28 2,347 (41) 878 (42) 125 ( 47) 267 ( 28) 250 (37) 215 (32) 132 (32) SOF/DCV 3,061 (28)…”

Section: Overall Treatment Outcomesunclassified

“…( 9 ) This includes settings with unrestricted access to DAAs such as Australia and Georgia; however, these generally report on select jurisdictions, ( 10 , 11 , 12 ) service types, ( 13 , 14 , 15 , 16 ) or treatment regimens. ( 17 ) Loss to follow‐up within these diverse cohorts varies from 4% to 33%, ( 11 , 13 , 15 , 17 ) highlighting a challenge with engaging individuals in posttreatment care. The evaluation of real‐world treatment outcomes and understanding characteristics of individuals who do not return for follow‐up in the Australian context is critical to guide future development and implementation of HCV services.…”

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confidence: 99%

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High Effectiveness of Broad Access Direct‐Acting Antiviral Therapy for Hepatitis C in an Australian Real‐World Cohort: The REACH‐C Study

et al. 2021

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Australia was one of the first countries with unrestricted access to government subsidized direct-acting antiviral (DAA) therapy for adults with chronic hepatitis C virus. This study assessed real-world DAA treatment outcomes across a diverse range of Australian clinical services and evaluated factors associated with successful treatment and loss to follow-up. Real-world Effectiveness of Antiviral therapy in Chronic Hepatitis C (REACH-C) consisted a national observational cohort of 96 clinical services including specialist clinics and less traditional settings such as general practice. Data were obtained on consecutive individuals who commenced DAAs from March 2016 to June 2019. Effectiveness was assessed by sustained virological response ≥12 weeks following treatment (SVR) using intention-to-treat (ITT) and per-protocol (PP) analyses. Within REACH-C, 10,843 individuals initiated DAAs (male 69%; ≥50 years 52%; cirrhosis 22%). SVR data were available in 85% (9,174 of 10,843). SVR was 81% (8,750 of 10,843) by ITT and 95% (8,750 of 9,174) by PP. High SVR (≥92%) was observed across all service types and participant characteristics. Male gender (adjusted odds ratio [aOR] 0.56, 95% confidence interval [CI] 0.43-0.72), cirrhosis (aOR 0.52, 95% CI 0.41-0.64), recent injecting drug use (IDU; aOR 0.64, 95% CI 0.46-0.91) and previous DAA treatment (aOR 0.50, 95% CI 0.28-0.90) decreased the likelihood of achieving SVR. Multiple factors modified the likelihood of loss to follow-up including IDU ± opioid agonist therapy (OAT; IDU only: aOR 1.75, 95% CI 1.44-2.11; IDU + OAT: aOR 1.39, 95% CI 1.11-1.74; OAT only, aOR 1.36; 95% CI 1.13-1.68) and age (aOR 0.97, 95% CI 0.97-0.98). Conclusion: Treatment response was high in a diverse population and through a broad range of services following universal access to DAA therapy. Loss to follow-up presents a real-world challenge. Younger people who inject drugs were more likely to disengage from care, requiring innovative strategies to retain them in follow-up. (Hepatology Communications 2022;6:496-512).D irect-acting antiviral (DAA) agents for hepatitis C virus (HCV) infection have revolutionized the assessment and management of individuals living with HCV. In the era of interferon-based therapy, treatment uptake was low due to toxicity and suboptimal efficacy. (1) Many people with HCV were unable to access treatment due to psychiatric disease, drug and alcohol use, advanced liver disease,

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“…1,661 (29) 214 (10) 47 (17) 127 (13) 125 (18) 59 ( 9) 117 ( 28 2,347 (41) 878 (42) 125 ( 47) 267 ( 28) 250 (37) 215 (32) 132 (32) SOF/DCV 3,061 (28)…”

Section: Overall Treatment Outcomesunclassified

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confidence: 99%

High Effectiveness of Broad Access Direct‐Acting Antiviral Therapy for Hepatitis C in an Australian Real‐World Cohort: The REACH‐C Study

et al. 2021

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“…Because of the similarity to GT1 within the non‐structural region of the recombinant virus's genome, 9 a 100% cure rate was achieved (10/10). A surprisingly high cure rate was observed among patients with GT2 and GT3 treated with the SOF/LDV regimens despite the presence of ACLD (97% and 99%, respectively) 22 …”

Section: Discussionmentioning

confidence: 97%

Assessment of treatment options for patients with hepatitis C virus recombinant form 2k/1b

Zakalashvili¹,

Zarkua²,

Gish

et al. 2020

Hepatology Research

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Aim Hepatitis C virus (HCV) intergenotype recombinant form (RF) 2k/1b has been actively circulating in HCV‐infected patients, and the prevalence of this RF virus in the Republic of Georgia is one of the highest reported worldwide. The aim of this study was to define the optimal treatment regimen for patients with RF_2k/1b. Methods We analyzed the data of 2735 patients who started treatment at the Medical Center Mrcheveli within Georgia's hepatitis C elimination program from May 2015 through December 2019. The patients were treated with sofosbuvir (SOF)‐based regimens. For identification of RF_2k/1b variants, refinement of standard (INNO‐LiPA) genotyping results for all patient samples assigned the unspecific HCV genotypes (GT) 2a/2c was carried out by sequencing of core and non‐structural protein 5B genes. Results Overall, 444 patients, representing 66% of GT2 and 16% of the total samples, were RF_2k/1b. Treatment of patients with RF_2k/1b with SOF/ledipasvir and SOF/velpatasvir was highly effective and viral cure rates did not differ among genotypes treated with the same regimen: RF_2k/1b, 99% (343/346); GT1, 99% (876/885); GT2, 96% (156/162); and GT3, 99% (545/552). A separate comparison analysis of sustained virologic response rate, treated with SOF plus ribavirin, showed significantly higher sustained virologic response (96%) in patients with confirmed GT2 (by sequencing) compared to unspecified GT2 (by INNO‐LiPA) (79%) (P < 0.05). Conclusion Sofosbuvir‐based regimens are highly effective for treatment of RF 2k/1b patients, and with availability of new pan‐genotypic direct‐acting antivirals, genotyping to identify RF 2k/1b patients might not be necessary.

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“…Our analysis confirmed previous recent reports on high real-life efficacy and sufficient tolerability of SOF plus RBV therapy for HCV GT2 patients with well-compensated cirrhosis. 10,[13][14][15][16][29][30][31][32][33][34][35][36][37] The same considerations can be made for DCV-based regimens, though resulting less studied in the recent literature. 10,16,34,[36][37][38][39] However, some important issues have to be addressed.…”

Section: Discussionmentioning

confidence: 99%

Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose

Smirne

D’Avolio

Bellan

et al. 2021

Pharmacology Res & Perspec

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Treatment outcomes of patients with chronic hepatitis C receiving sofosbuvir-based combination therapy within national hepatitis C elimination program in the country of Georgia

Cited by 3 publications

References 0 publications

High Effectiveness of Broad Access Direct‐Acting Antiviral Therapy for Hepatitis C in an Australian Real‐World Cohort: The REACH‐C Study

High Effectiveness of Broad Access Direct‐Acting Antiviral Therapy for Hepatitis C in an Australian Real‐World Cohort: The REACH‐C Study

Assessment of treatment options for patients with hepatitis C virus recombinant form 2k/1b

Sofosbuvir‐based therapies in genotype 2 hepatitis C virus cirrhosis: A real‐life experience with focus on ribavirin dose

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