The Foundation for the Fight against Infections is participating as the world’s leading recruitment center in a registry study confirming the effectiveness of a medication against acute hepatitis C.
Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV), which primarily affects the liver. It is transmitted mostly through contact with the blood of an infected person and high-risk sexual exposure. Hepatitis C can present in two phases: the acute phase, which can be asymptomatic or show mild symptoms such as fatigue, nausea, loss of appetite, and jaundice (yellowing of the skin and eyes); and the chronic phase, which starts after six months and can last indefinitely. Often, there are no symptoms in the chronic phase, but it can cause progressive liver damage that may lead to cirrhosis of the liver or the development of liver tumors.
Chronic hepatitis C is definitively cured with direct-acting antiviral treatments that offer close to 100% efficacy. Currently, pan-genotypic regimens are used that are effective against all genotypes of the hepatitis C virus. Basically, combinations such as sofosbuvir-ledipasvir or glecaprevir-pibrentasvir are used, both containing two direct-acting antivirals. These medications are not only revolutionary in their effectiveness but are also easy to take over a period of 2 to 3 months. These regimens are specifically indicated for the treatment of chronic hepatitis C and are not reimbursed in Spain for the treatment of acute forms.
For this reason, the laboratory Abbvie promoted the study M20-350 with the purpose of confirming if the same medication that controlled chronic hepatitis C could also cure acute hepatitis C.
So, during the period 2022-2023, this clinical research was conducted to confirm the efficacy and safety of treating acute hepatitis C. Finally, this clinical research has demonstrated that one hundred percent of the individuals treated, who completed the treatment for acute hepatitis C, are permanently cured using the same medication.
Dr. Josep M. Llibre, researcher at the Fight Infections Foundation and physician at the Department of Infectious Diseases of the Hospital Universitario Germans Trias i Pujol, comments: ‘This clinical trial has been conducted in 70 different healthcare centers across 8 countries. Among all of them, the Foundation for the Fight against Infections has been the world’s leading recruiting center, contributing 41 participants. This is particularly exciting for us because it demonstrates the dedication of the entire team. I would also like to highlight the collaboration of BCN checkpoint, especially Dr. Angel Rivero. The study aimed to recruit 270 participants, and ultimately 286 were recruited.
Indication registry study
An indication registry study is a clinical investigation aimed at collecting and analyzing real-world data on the use of a specific medication in a defined population for whom the treatment is indicated. The ultimate goal of the study is to confirm the effectiveness and safety of the medication and obtain its approval.
Therefore, the M20-350 study, which confirms the treatment of acute hepatitis C using the medication glecaprevir/pibrentasvir marketed under the name Maviret, has been classified as an indication registry study. Consequently, regulatory agencies will authorize this medication for use with this new indication in humans.
El Dr. Josep M. Llibre añade: “Right now, we are at a moment where we can eradicate Hepatitis C. However, because the population travels so much, even if we were to eliminate, for example, Hepatitis C in Catalonia, if there are people with Hepatitis C who are not treated and they travel here maintaining risky transmission behaviors, we could have small outbreaks of hepatitis in the region again”.
Why can we cure Hepatitis C and not HIV?
All the research that has been carried out to combat HIV infection has been applied en bloc to hepatitis B, C and delta. Determinations of viral loads, combined treatments, therapeutic targets of drugs (protease and polymerase inhibitors). So why cure hepatitis C virus infection, but not yet cure hepatitis B or HIV?
The difference in curing both infections is mainly framed by the biological characteristics of the viruses and how they infect cells in the body. The key difference between eliminating Hepatitis C and HIV lies in the fact that the replicative cycle of HIV (and Hepatitis B) also occurs within the nucleus of human cells and integrates into their genetic material permanently. In contrast, the replicative cycle of Hepatitis C does not enter the nucleus of cells and thus does not integrate. As long as direct-acting antivirals can completely eliminate all HCV from the body over a specific period of time, this infection will be definitively cured. Conversely, managing HIV is much more complex and still requires solving the challenge of eradicating viruses already integrated into the genome of host cells.
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