Barcelona – Medicines Gilead Sciences Major progress made in battle against most dangerous virus that causes hepatitis in humans Hepatitis D.this European Commission Full marketing authorization granted for the drug Hepcludex (Bleville)This is the only specific treatment proven to be effective against this infection, compared with others that attack other pathogens liver.
The milestone comes after four years of uncertainty in the process of characterizing innovative treatments.The drug was first submitted to European Medicines Agency (EMA) In October 2019, conditional approval was granted in July 2020 due to promising results from the Phase 1 II trial, even with a small number of patients. New Phase III data (with more participants) also took three years to confirm and expand on potential benefits: After 96 weeks, as many as 56% of patients responded well to the treatment.
However, Hepcludex is rejected American Pharmacy (FDA); First of all, if you have any doubts Safety and effectiveness And, late last year, issues related to its manufacturing industry. He also encountered misgivings from several countries when it came to integrating it into their health systems. In addition to uncertainty about its effectiveness, another important reason is the high price (up to 163,000 euros per patient in Germany) that Gilead is able to reduce mortality.
Spain twice rejected public financing for Hepcludex. The inter-professional Committee on Autonomous Community Involvement on the Pricing of Medicines (CIPM) was first considered in November last year.Restrictions related to this drug Results for efficacy and duration of treatment persist, which do not justify the high cost and budget impact. ” said the document released by CIPM.
The second rejection occurred in March this year and had similar arguments. Gilead and Health continue to negotiate, and industry sources expect CIPM to not look at the case again until the last quarter of this year. “The EMA’s full endorsement clears some uncertainty about effectiveness, but the economic differences remain important,” the health authority’s source explained.
he hepatitis delta virus It has several characteristics that make it extraordinary. One is its tiny size, even in a world of viruses: It measures only about 36 nanometers (one-third of a millimeter).It is so small that it cannot replicate itself and needs to be attached to a membrane Hepatitis B virus go a head. Therefore, to infect a human, the person must have previously suffered from the disease.
Another special fact is that it Interesting origin.Most experts place it in plants, making the virus one of the rare examples Infectious diseases caused by the plant world. “It has enzymes called ribozymes, which are not normally found in viruses that affect humans and animals. They are typical of plant viruses. The leading hypothesis is that, although still under investigation, at some point it allowed humans to fly to humans. Another explanation is that it is an aberration, a strange mutation that affects its RNA strand.
this Prevalence Disease in the world is another unknown surrounding it. “We don’t have very strong data. Estimates usually made are that about 5% of people with hepatitis C also have D, which would infect about 5,000 people in Spain. But many cases are not being detected in hospitals and there may be some reports,” Javier García-Samaniego, head of the Department of Hepatology at La Paz Hospital in Madrid.
Both types of hepatitis spread through similar routes: contact with blood and, to a lesser extent other body fluidsso the main routes of transmission are sexual relations and contact with needles or other contaminated instruments.
Both viruses also cause similar clinical symptoms: Chronic hepatitis, tending to cirrhosis The end is death. “But hepatitis B, the most severe form of viral hepatitis, is the one that most frequently and aggressively progresses toward complications with a poor prognosis.” Still, there are no precise data on mortality from the disease, Part of the reason is that it’s difficult to discern the exact reasons why health and death worsen in people who have both infections coexisting.
According to data in the hands of experts, in fact, half of the people diagnosed with hepatitis virus in Spain have cirrhosis, a much higher percentage than other types of hepatitis. “Cirrhosis due to the hepatitis B virus virtually no longer occurs because of treatments that cure the infection. With B, they are rare because although there is no cure, we can align it with the treatments that are available.” D is an open question,” García-Samaniego said.
In the long run, experts say, both diseases should disappear. “Hepatitis C vaccine is key. This disease is preventable, and if we eliminated B, the D virus would no longer be a threat because it would not cause any damage on its own. ” Buti explained.
But there are still decades to go before this happens. Universal vaccination against hepatitis C was introduced in Spain in the early 1990s, with a high coverage rate of about 98%, according to data from the Ministry of Health. “If there are no new infections in the population, B will disappear, and that will come with it. But now we have about 100,000 people with chronic hepatitis B who can shrink, and we have to add that in countries that are vaccinated, which It’s not very widespread, and there’s a higher incidence of hepatitis. It’s a virus that affects vulnerable groups,” García-Samaniego said.
he Herpurux It works by blocking the receptors through which viruses enter liver cells. This treatment does not cure the disease, but it does in about half of patients. Try to reduce viral load and normalize transaminase levelsAccording to experts consulted. Although studies have not confirmed this, this should include an associated mortality rate.
Rivero Juárez is more cautious. “As the FDA rejection demonstrates, many uncertainties remain. Available data are limitation More progress is needed in research, but this is the only option with proven effectiveness for patients today. “He said.
The market launch of Hepcludex also highlights the challenges posed to the sustainability of health systems by the price of new treatments, which in this case are designed to make financial investments profitable rather than research costs. Hepcludex was not developed by Gilead but by German Biotechnology MYR. In December 2020, five months after the EMA’s first conditional approval of the drug, Gilead acquired Myr for approximately €1.3 billion due to the economic potential of the new treatment.
Author: Oriol Guell
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