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Updated guidelines for treating viral hepatitis C: new drugs for all patients

The American Association for the Study of Liver Diseases (AASLD) and the Infectious Disease Society of America (IDSA) have updated the guidelines for the treatment of patients with viral hepatitis C (HCV). According to the current approach, to the problem of treating viral hepatitis C, all patients in whom the hepatitis C virus is detected should receive new modern drugs.

The recommendations begin with the explanation that new oral drugs specific to the hepatitis C virus that can cure HCV are already approved in the United States.

According to the new edition of practical recommendations, a stable virological response, which is the main parameter of a successful response to treatment, can be obtained in almost all patients infected with hepatitis C. In addition, many patients at high risk may receive treatment with new drugs.

Currently in the United States, 3-4 million people are diagnosed with chronic hepatitis C, and about half of them do not know they are sick.

In 2013-2014 The U.S. Food and Drug Administration (FDA) approved oral hepatitis C drugs, protease and polymerase inhibitors, which have what is known as the direct antiviral effect, blocking key intracellular stages of virus reproduction.

The advantage of new drugs, unlike antiviral therapy with peginterferon and ribavirin, is the possibility of taking drugs inside (tablets or capsules), high efficiency and good tolerability of the therapy. The main disadvantage is the cost. The course of treatment can reach 200,000 US dollars.

Sofosbuvir, an RNA polymerase inhibitor, is capable of inhibiting the replication of the hepatitis C virus. Used to treat patients with virus genotypes 1, 2, 3 and 4. For patients with genotype 1 and 4, sofusbovir is used with peginterferon and ribavirin for 12 weeks, with virus genes 2 and 3 - only with ribavirin for 12 and 24 weeks, respectively.

The treatment regimen may be changed in the presence of cirrhosis and in the absence of a response to previous treatment for HCV. The probability of recovery for patients with genotype 2 and 3 and for people who have not yet received treatment with genotype 1 is approximately 90%. The cost of a 12-week sofusbovir course is approximately $ 84,000.

One of the most promising combinations of drugs for the treatment of HCV, which was developed by Gilead Sciences, was Harvoni (sofusbovir + ledipasvir), the efficacy of which in patients with the 1st and 4th genotypes of the virus exceeds 90 %.

This combination drug is prescribed for 12 weeks without concomitant use of interferon. Based on the results of clinical studies, high efficacy and safety have been demonstrated in genotype 1 patients without cirrhosis and with cirrhosis, as well as in the absence of response to previous antiviral therapy. Depending on the presence of cirrhosis and the failure of the previous treatment, the duration of treatment can vary from 8 to 24 weeks.

The cost of the brand-name drug is around $ 1,125 per pill, so a 12-week course can cost more than $ 100,000.

Simeprevir (Olysio) is another drug in the group of protease inhibitors that blocks the key reproductive enzyme of the hepatitis C virus.

Simeprevir is used to treat patients with HCV and genotype 1b who have already received treatment, and in untreated patients with and without cirrhosis. Simeprevir is used exclusively as part of standard antiviral therapy or in combination with other protease / polymerase inhibitors.

For patients not previously treated, simeprevir is used in combination with peginterferon and ribavirin for 12 weeks, after which treatment is continued without simeprevir for an additional 12 weeks. In patients who respond poorly to treatment, the second stage can be extended to 36 weeks.

Good results have been demonstrated by the use of a combination of simeprevir and sofosbuvir for 12 weeks in patients with 1 genotype, including individuals with cirrhosis. The cost of a 12-week simeprevir course is $ 25,000.

The combined drug ombitasvir / paritaprevir / ritonavir / dizabuvir (Viekira Pak, company AbbVie) was approved in the United States in 2014. The drug has shown high clinical efficacy in patients with genotype 1, including genotype 1a, and in patients with cirrhosis, as well as in individuals with previous ineffectiveness of therapy with interferon and ribavirin. The duration of treatment is 12 to 24 weeks, both in combination with and without ribavirin. The cost of 12 weeks of treatment with Viekira Pak is approximately $ 84,000.

Daclatasvir is a pangenotypic inhibitor of the NS5A replication complex, used to treat patients with chronic hepatitis C virus in combination with other medicines to treat viral hepatitis C 1, 2, 3, and 4 genotypes. in adults. Currently, daclatasvir is used with sofosbuvir, asunaprévir and peginterferon alpha + ribavirin. In patients with genotype 3 of the virus, a 12-week treatment of daclatasvir in combination with sofosbuvir and ribavirin is performed. This scheme allows you to obtain a persistent virological response in 90% of patients. For the treatment of patients with 1 genotype, a combination with sofosbuvir for 12-24 weeks without ribavirin is also used.

The cost of 12 weeks of treatment with daclatasvir is $ 45,000.

According to medical professionals working in the United States, it is unfortunately very difficult for doctors to guarantee reimbursement by insurance companies of the cost of treating patients.

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