Available in Brazil
In Brazil, liver cirrhosis was the cause of death for over 265,000 people between 2000 and
2012. The mortality rate from cirrhosis in 2012 was 12 deaths per 100,000 inhabitants, and
the number of deaths from liver cirrhosis increased by about 22% in the last decade.
Recently, hepatitis C treatment has been revolutionized by the use of direct-acting
antivirals (DAAs), which are safe and highly effective oral medications. Cure rates for
hepatitis C, known as sustained virological response (SVR), in studies conducted in Brazil
and Latin America were higher than 90%. Hepatitis C cure (SVR) is associated with a reduction
in the incidence of HCC, the need for liver transplantation, improvement in quality of life,
and a decrease in HCV transmission. These new medications have been available for hepatitis C
treatment through the Brazilian Public Health System, known as Sistema Único de Saúde (SUS)
since 2015.
The Ministry of Health of Brazil signed an agreement with the WHO in 2016 and with the goal
of defining public health strategies to eliminate viral hepatitis by 2030, reducing new
infections by 90% and global hepatitis-related mortality by 65%.
Identifying individuals with HCV infection is crucial for the (micro) elimination of
hepatitis C. The majority of chronically infected HCV patients are asymptomatic until the
development of liver cirrhosis and/or its complications. Therefore, screening for HCV
infection should be performed in individuals, even when asymptomatic, through HCV antibody
(HCVab) test. Currently, HCV rapid tests (HCVRT) in fingerstick blood with results in 15-20
minutes are available in Brazil.
Historically, HCV screening was recommended for individuals over 40 years of age and
high-risk populations for HCV infection, such as people who inject drugs (PWID), prisoners,
and men who have sex with men (MSM). However, recent international guidelines recommend
screening for all individuals aged 18-79. Active HCV infection should be confirmed by
detecting HCV viral load using molecular tests by polymerase chain reaction (PCR). Currently,
the identification of HCV-RNA by PCR as a point-of-care tests (PoCT), GeneXpert® System, is
also possible. The Xpert HCV VL Fingerstick test has excellent accuracy for detecting HCV-RNA
in fingerstick blood, providing results in up to 105 minutes.. Liver elastography is a rapid
imaging method (< 5 minutes), similar to abdominal ultrasound, painless, and free of
complications, that can be performed at the bedside and provides real-time results for
fibrosis stage/liver cirrhosis diagnosis. The technical principle of this method is based on
measuring the propagation of ultrasound waves, called shear waves, through the liver
parenchyma, estimating the organ's fibrosis degree through liver stiffness measurement (LSM).
Currently, portable/semi-portable hepatic elastography devices are available, allowing for
the staging of liver fibrosis in regions with difficult access to healthcare.
Globally, the HCV continuum of care is still deficient, as only about 10% of identified
hepatitis C patients achieve SVR. Brazil also observes a similar scenario of deficiencies in
the HCV cascade of care. People living with HCV are typically treated in tertiary centers by
specialists (infectious disease specialists, hepatologists, gastroenterologists). Multiple
pre-treatment visits (diagnostic confirmation, biological analyses, and staging of liver
fibrosis) are required, along with visits during treatment (clinical visits and biological
analyses) and after medication use (evaluation of hepatitis C cure). This process can be even
more complicated in certain stigmatized, highly vulnerable populations, and/or those with
difficult access to healthcare. The hepatitis C treatment cascade can be improved, especially
with recent advances in techniques for diagnosing/confirming HCV infection and the
availability of pan-genotypic and simple therapeutic regimens (one tablet orally per day for
12 weeks, "one-size-fits-all"), extremely safe and highly effective (even in patients with
advanced fibrosis/liver cirrhosis). The simplification of hepatitis C treatment leads to
higher detection and treatment rates (increased access to treatment), rapid initiation of
treatment post-diagnosis (rapid linkage-to-care), reduced HCV transmission (treatment as a
prevention tool), and cost reduction associated with cirrhosis complications/liver
transplantation. Additionally, international studies have described that the response rates
to hepatitis C treatment by non-specialists in the Primary Health Care System with DAAs seems
to be similar to those treated by specialists. However, the best strategy for managing
hepatitis C within the Brazilian-SUS is not yet widely defined.
1Research sites
30000Patients around the world