New hepatitis C drugs show rates of up to 98% cure
It is a silent disease, rarely causes symptoms, so most people with HCV do not know they are infected, only find out if they take a specific test. About 90% of infected people do not clear the virus and become chronically infected, and approximately 20% of them will develop cirrhosis, of which 25% may progress to liver cancer.
The usual treatment for hepatitis C is done with a combination of pegylated interferon, used by subcutaneous injection, and oral drug ribavirin, for a period of 24 or 48 weeks, depending on the genotype. This treatment has many side effects, mainly resulting from interferon, which include headache, fever, muscle aches, tiredness, loss of appetite, weight loss, pruritus, depression, as well as a decrease in white blood cells, platelets and anemia. Therefore, many patients with HCV can not undergo therapy, such as those with cirrhosis, with psychiatric and autoimmune diseases. In addition, only 40-50% of treated patients achieve cure, or sustained virologic response, which would be no virus detection 12 weeks after the end of treatment.
Hepatitis C is one of the few chronic diseases that can be cured, this possibility becomes more real with the advent of these new medicines for oral use
From 2011, for patients with genotype 1 and with advanced disease, one of two drugs was added orally with antiviral action, protease inhibitor, boceprevir or telaprevir. With this triple therapy the chance of cure rose to 70%. However, it is limited to genotype 1 and there is an increase in side effects, with more severe anemia and sometimes severe dermatological conditions.
Hepatitis C is one of the few chronic diseases that can be cured, this possibility becomes more real with advent of these new oral medications, without the need for interferon, used for shorter periods and with fewer side effects. New drugs have been studied in order to obtain a treatment with fewer side effects and a greater chance of cure. Sofosbuvir is the first drug of this new generation, direct acting antiviral, which acts as an inhibitor of an essential enzyme for the replication of virus C, the polymerase NS5B ribonucleic acid. Sofosbuvir is well tolerated, with little or no side effects.
Studies with sofosbuvir associated with peginterferon and ribavirin show cure rates between 80 and 98%, in addition to reducing treatment time for 12 weeks. Searches with sofosbuvir and ribavirin without interferon have shown response ranging from 64 to 100%, and with good safety.
Clinical studies with Simeprevir, a drug that acts similarly to Sofosbuvir, in combination with pegylated interferon and ribavirin, have achieved a cure between 68% and 86% of the patients. patients. The reported side effects were associated with pegylated interferon and ribavirin.
The FDA (
Food and Drugs Administration
), an American agency equivalent to ANVISA in Brazil, authorized the marketing of Sofosbuvir and Simeprevir for the treatment of hepatitis C, so one of the two could be incorporated into the scheme with pegylated interferon and ribavirin, with a greater chance of cure and reduced treatment time, but there will still be restriction to patients intolerant or with contraindication to interferon or ribavirin. Interferon and Ribavirin can be administered in combination with all patients with HCV (above 95%) in less time and with good tolerance even for patients suffering from advanced stage. But this association has not yet been approved by any regulatory agency.
The bad news, though, is the cost of these drugs. The treatment used today in Brazil costs about 90 thousand reais for six months. It is estimated that treatment with the new molecules for three months will leave for 90 thousand euros, equivalent to more than 280 thousand reais. The cost of sofosbuvir for three months (treatment time) is $ 84,000 (about R $ 184,000). The cost of simeprevir is US $ 66 thousand (R $ 144 thousand). Daclatasvir
Patients with hepatitis C virus had good news earlier this year: the drug daclatasvir had the reg- ister released by Anvisa. After the registration of the drug, the National Commission for the Incorporation of Technologies in the SUS (Conitec) will evaluate the use in the public network, which can take up to six months. Although it is very good news, it is still early to celebrate, because this medicinal product must not be used in isolation, it must be used in combination with some other antiviral medication. Daclatasvir has been discharged while two or more sofosbuvir and simimevir are still awaiting registration. Registration is the document that allows the sale of a drug in the country. Therefore, in spite of this release for commercialization and use of this drug in Brazil, it is still necessary to register and release the others so that an adequate treatment can be made.
After the release of the medicines will still be necessary evaluation of the treatment guidelines, or treatment schemes according to the genotype of the virus and the severity of the clinical picture. Because the drugs to be associated depend on the genotype of the virus, and the period of treatment varies according to the stage of the disease. In addition, priorities will be defined, ie patients will have priority in treatment, usually patients with more severe disease, more advanced, will be the first to receive the new treatment.
In addition to having a higher cure rate with use of these drugs, reaching 90%, the treatment period is reduced from 48 to 24 or 12 weeks and the advantage of oral use. In addition, they are drugs with less toxicity, with fewer side effects.
The registration of the three remedies - sofosbuvir, simeprevir and daclatasvir - and their incorporation into the SUS was a demand of hepatitis C associations. We hope to achieve in 2015 not only to analyze the technological incorporation, but also the acquisition and distribution of these drugs.
Other antiviral agents, more potent protease inhibitors, polymerase inhibitors, nucleoside or nucleotide analogues and inhibitors of the NS5A complex are also being studied, such as faldaprevir, daclatasvir, ledispavir, asunaprevir. Studies with the combination of daclatasvir and asunaprevir, ledipasvir and sofosbuvir, and non-interferon-containing simeprevir with or without ribavirin, with ritonavir, sofosbuvir or daclatasvir, for 8 to 24 weeks showed response rates ranging from 82 to 99%. daclatasvir (NS5A inhibitor) has been studied in over 5500 patients in combination with other oral antivirals and with interferon and ribavirin. It showed action in all genotypes, had low drug interaction and could be used in patients with comorbidities. Studies with the combination of daclatasvir and Sofosbuvir for 12 to 24 weeks with or without ribavirin showed sustained virologic response rates ranging from 92 to 100% with no significant side effects.
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