BACKGROUND AND AIMS: The year 2023 marked the 10-year anniversary of the launch of direct-acting antivirals (DAAs) for the treatment of the hepatitis C virus (HCV). HCV treatment trends by country, region, and globally are important to monitor progress toward the World Health Organization's 2030 elimination targets. Additionally, the historical patterns can help predict the treatment uptake for future therapies for other liver diseases. METHODS: The number of people living with HCV (PLHCV) treated between 2014-2023 across 119 countries was estimated using national HCV registries, reported DAA sales data, pharmaceutical companies' reports, and estimates provided by national experts. For the countries with no available data, the average estimate of the corresponding Global Burden of Disease region was used. RESULTS: An estimated 13,816,000 (95% uncertainty intervals (UI): 13,221,000-16,415,000) PLHCV were treated, of whom 12,748,000 (12,226,000-15,231,000) were treated with DAAs, of which 11,081,000 (10,542,000-13,338,000) were sofosbuvir-based DAA regimens. Country-level data accounted for 97% of these estimates. In high-income countries, there was a 41% drop in treatment from its peak, and reimbursement was a large predictor of treatment. In low- and middle-income countries, price played an important role in expanding treatment access through the public and private markets, and treatment continues to increase slowly after a sharp drop at the end of the Egyptian national program. CONCLUSIONS: In the last 10 years, 21% of all HCV infections were treated with DAAs. Regional and temporal variations highlight the importance of active screening strategies. Without program enhancements, the number of treated PLHCV stalled in every country/region which may not reflect a lower prevalence but may instead reflect the diminishing returns of the existing strategies. IMPACT AND IMPLICATIONS: Long-term hepatitis C virus (HCV) infection can lead to cirrhosis and liver cancer. Since 2014, these infections can be effectively treated with 8-12 weeks of oral therapies. In 2015, the World Health Organization (WHO) established targets to eliminate HCV by 2030, which included treatment targets for member countries. The current study examines HCV treatment patterns across 119 countries and regions from 2014 to 2023 to assess the impact of national programs. This study can assist physicians and policymakers in understanding treatment patterns within similar regions or income groups and in utilizing historical data to refine their strategies in the future.
- Klíčová slova
- Global, Polaris Observatory, Regions, WHO regions, World Bank regions,
- Publikační typ
- časopisecké články MeSH
BACKGROUND & AIMS: Eight-week glecaprevir/pibrentasvir leads to high rates of sustained virological response at post-treatment week 12 (SVR12) across HCV genotypes (GT) 1-6 in treatment-naïve patients without cirrhosis. We evaluated glecaprevir/pibrentasvir once daily for 8 weeks in treatment-naïve patients with compensated cirrhosis. METHODS: EXPEDITION-8 was a single-arm, multicenter, phase IIIb trial. The primary and key secondary efficacy analyses were to compare the lower bound of the 95% CI of the SVR12 rate in i) patients with GT1,2,4-6 in the per protocol (PP) population, ii) patients with GT1,2,4-6 in the intention-to-treat (ITT) population, iii) patients with GT1-6 in the PP population, and iv) patients with GT1-6 in the ITT population, to pre-defined efficacy thresholds based on historical SVR12 rates for 12 weeks of glecaprevir/pibrentasvir in the same populations. Safety was also assessed. RESULTS: A total of 343 patients were enrolled. Most patients were male (63%), white (83%), and had GT1 (67%). The SVR12 rate in patients with GT1-6 was 99.7% (n/N = 334/335; 95%CI 98.3-99.9) in the PP population and 97.7% (n/N = 335/343; 95% CI 96.1-99.3) in the ITT population. All primary and key secondary efficacy analyses were achieved. One patient (GT3a) experienced relapse (0.3%) at post-treatment week 4. Common adverse events (≥5%) were fatigue (9%), pruritus (8%), headache (8%), and nausea (6%). Serious adverse events (none related) occurred in 2% of patients. No adverse event led to study drug discontinuation. Clinically significant laboratory abnormalities were infrequent. CONCLUSIONS: Eight-week glecaprevir/pibrentasvir was well tolerated and led to a similarly high SVR12 rate as the 12-week regimen in treatment-naïve patients with chronic HCV GT1-6 infection and compensated cirrhosis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03089944. LAY SUMMARY: This study was the first to evaluate an 8-week direct-acting antiviral (DAA) regimen active against all major types of hepatitis C virus (HCV) in untreated patients with compensated cirrhosis. High virological cure rates were achieved with glecaprevir/pibrentasvir across HCV genotypes 1-6, and these high cure rates did not depend on any patient or viral characteristics present before treatment. This may simplify care and allow non-specialist healthcare professionals to treat these patients, contributing to global efforts to eliminate HCV.
- Klíčová slova
- Chronic HCV infection, Compensated cirrhosis, Direct-acting antiviral, Glecaprevir/pibrentasvir, HCV elimination, Hepatitis C virus, Pangenotypic, Short duration,
- MeSH
- antivirové látky aplikace a dávkování škodlivé účinky MeSH
- benzimidazoly aplikace a dávkování škodlivé účinky MeSH
- chinoxaliny aplikace a dávkování škodlivé účinky MeSH
- chronická hepatitida C krev komplikace farmakoterapie virologie MeSH
- cyklopropany aplikace a dávkování škodlivé účinky MeSH
- fixní kombinace léků MeSH
- genotyp * MeSH
- Hepacivirus enzymologie genetika MeSH
- jaterní cirhóza komplikace farmakoterapie MeSH
- kyseliny aminoisomáselné aplikace a dávkování škodlivé účinky MeSH
- leucin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- lidé středního věku MeSH
- lidé MeSH
- makrocyklické laktamy aplikace a dávkování škodlivé účinky MeSH
- polymorfismus genetický MeSH
- prolin aplikace a dávkování škodlivé účinky analogy a deriváty MeSH
- pyrrolidiny aplikace a dávkování škodlivé účinky MeSH
- RNA virová krev genetika MeSH
- senioři MeSH
- setrvalá virologická odpověď MeSH
- sulfonamidy aplikace a dávkování škodlivé účinky MeSH
- virové nestrukturální proteiny genetika MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- antivirové látky MeSH
- benzimidazoly MeSH
- chinoxaliny MeSH
- cyklopropany MeSH
- fixní kombinace léků MeSH
- glecaprevir MeSH Prohlížeč
- kyseliny aminoisomáselné MeSH
- leucin MeSH
- makrocyklické laktamy MeSH
- NS-5 protein, hepatitis C virus MeSH Prohlížeč
- NS3 protein, hepatitis C virus MeSH Prohlížeč
- pibrentasvir MeSH Prohlížeč
- prolin MeSH
- pyrrolidiny MeSH
- RNA virová MeSH
- sulfonamidy MeSH
- virové nestrukturální proteiny MeSH
