When at the end of 2013 at the 64th Annual Meeting of the American Association for the Study of Liver Diseases, held in Washington, it was announced that drugs had been discovered capable of overcoming the hepatitis C virus, identified in 1989, there were those who dreamed that the silent epidemic that causes around 400,000 deaths per year could be eradicated.
Hepatitis C leads to cirrhosis and liver cancer, and is the leading cause of liver transplantation. It is estimated that in Argentina it would affect 600,000 people (1.5% of the population), 240,000 of whom would suffer from advanced disease, many of them without knowing it. The new drugs promised to cure between 90 and 100% of patients with short treatments and without adverse effects.
But what had not been taken into account was the price. At about $ 90,000 for treatment in those early days, the goal that everyone affected could benefit from their benefits was difficult to achieve.
Now, a generic developed by a local pharmaceutical company showed that it has similar effectiveness and safety profiles than the original, and a significantly lower cost.
The last successful test was a multicenter study that included 321 patients from 15 centers with chronic hepatitis C (91% of whom had liver cirrhosis). In it participated the Italian, Posadas, Muñiz, Ramos Mejia and Udaondo hospitals of the City of Buenos Aires; the Centenary, of Rosario; the Center for Outpatient Medical Specialties, Mar del Plata; Hospital Doctor Oñativia, of Salta; the Nephrology Clinic of Santa Fe; the Central Hospital of Mendoza; and the Rossi Hospital, in La Plata.
In the study, 58% received the generic formulation of sofosbuvir, as the antiviral is called, and 95% of patients responded to the treatment.
"Although our study was not designed to compare the sustained response between patients who received both formulations (the original and the biosimilar), we observed similar virological responses," the authors write in the paper published in the Journal of Medical Virology.
"We are in favor of the patent law, we have to respect it," says Elvira Zini, scientific director of Laboratorios Richmond, which makes the national product. "But then comes the moment in which enter those that develop generic products. In the case of sofosbuvir it was a great help for the patients of Argentina because the original product was not being approved because of its very high cost. Since this is a molecule very similar to AZT, the antiretroviral against HIV, with which we got a lot of experience, we had done a long road and were able to launch it in December 2016. "
According to Marcelo Figueiras, president of the company, at first doctors could not believe that a product with so much difference in price had the same quality, but several pharmacovigilance studies that already included about 800 patients were showing how the viral load goes down to zero and holds up in time.
"Both our study at the Italian Hospital and that of the Association for the Study of Hepatic Diseases, the generic one gives exactly the same result as the original one – points out Dr. Adrián Gadano, head of the Hepatology section of this hospital – . At the beginning we had some distrust, that's why we measured very closely the drop in viral load."
"There are already more than 2,000 patients treated," Figueiras adds, "which saved about 300 million dollars. Ideally the treatment would begin before the patients have a very damaged liver."
And Gadano agrees: "The earlier you begin to treat the better the cost-benefit balance, in fact, now the Ministry is beginning to treat all patients."