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Colombian standard treatment is more effective to treat hepatitis C

Famous Colombian bullfighter César Rincón contracted hepatitis C (HCV) 19 years ago, a blood transfusion received before to save his life was the culprit for contracting the disease. He battled the disease for several years, after suffering from tiredness, loss of appetite, weight loss and depression, but finally recovered. However other patients may take a lot longer or have less encouraging results if not diagnosed and treated opportunely.

The World Health Organization (WHO) claims that between 60% and 80% of the people with the disease develop a chronic disease, with the risk of suffering cirrhosis or liver cancer, two aggravating circumstances which could lead to a liver transplant to save their lives.

Although the diagnosis and treatment are considered as the variables which most influence the effectiveness of the process, a molecular study shows the link between the rs12979860 polymorphism (a variation of the DNA sequence) and the sustained virologic response (SVR) in hepatitis C genotype 1b in the therapeutic stage.

SVR is a prolonged and continued reduction of the viral load of the virus and can reach undetectable levels as result of treatment with antiretroviral medications.

Universidad Nacional de Colombia (UNal) Sciences-Microbiology M.Sc. David Carreño says that the most frequent genotype in the Colombian population is the 1b; discovering such association helps infection disease doctors or hepatologists to provide a predictive percentage of the number of patients diagnosed which respond to the treatment.

From the scientific literature reviewed, Carreño discovered that patients infected with 2 and 3 genotypes have more possibilities of reaching an SVR, with a lower dose of ribavirin and with a shorter treatment than those infected by genotype 1.

The genotype treatment

For his research project between 2008 and 2015, Carreño chose 60 hepatitis C patients from a Bogotá hospital. These patients needed to have the 1b genotype hepatitis and having taken the first dose of 48 weeks with pegylated interferon and ribavirin, a standard treatment applied in Colombia to treat hepatitis C.

With the information obtained in the clinical laboratory and patient data, the researcher created a database with the purpose of determining the genotype of the virus, the gene IL28B polymorphism and the variation of the sequence of a determined DNA locus.  DNA was extracted from patient blood samples in order to determine the polymorphism of the IL28B gene using molecular biology techniques.

“From this process, we applied a statistical analysis to determine if treatment had been effective according to the genotype. Furthermore, we carried out a logistical regression to determine if the presence of polymorphisms had influenced or not patient treatment,” said Carreño.

One of the most conclusive results is that 65% of the patients analyzed did not reach an SVR after the treatment with pegylated interferon and ribavirin, while the remaining percentage (35%) achieved it 24 weeks after having finished the pharmacological treatment. The researcher clarifies that although the SVR is linked to a healing guarantee, there is still a low percentage of patients which suffer from relapse which compels them to retake treatment.

After determining the rs12979860 polymorphism of the IL28B gene for each patient according to the blood samples, they calculated the percentage of genotypes:

  • El 11.67% (7) were homozygote CC.
  • El 21.67% (13) homozygote TT.
  • El 66.67% heterozygote.

With the genotype analysis, they determined that 71.43% of the patients with CC genotype reached a SVR, while 28.57% did not achieve it. The SVR frequency in patients CT/TT genotype was 30.19%.

The results show a significant association between the SVR and the presence of the CC genotype in face of the not CC genotype (CT/TT) of the rs12979860 polymorphism of the IL28B gene. Furthermore, they analyzed the possibility that after 24 weeks of terminating the treatment with pegylated interferon and ribavirin they could reach a more convincing response.

Carreño highlights the usefulness of analyzing the IL28B gene polymorphism as a predictor of the viral response after treatment; although he adds that it is necessary to carry out this same research with new direct-acting antiviral agents (DAA) medications such as telaprevir, boceprevir and others which are now in the pharmacological market for the treatment of HCV.

Medications in dispute

According to the Colombian Ministry of Health, the modern antiviral medications which entered the market have reached an efficacy of 94% for the treatment of hepatitis C, although the high cost hindered it could be applied to all patients with the disease. The Ministry estimates that currently, 400,000 people carry the virus and 60,000 will require treatment between 2018 and 2030.

Due to this, the Ministry began a process of declaring medications for treating hepatitis C of public interest and lowering prices to facilitate and strengthen equality in the health sector.

However, a letter from the Pharmaceutical Research and Manufacturers of America (PhRMA) requested revoking the regulation as it ignores international patent regulations which Colombia had pledged to respect.

Carreño claims his research project emerged from the announcement of the Colombian Ministry of Health as it was necessary to first assess the standard treatment, which was applied for years in Colombia, to them implement the antivirals which cost 6 or 7 times more than pegylated interferon and ribavirin.

 

Consejo Editorial