Trinidad & Tobago Ministry of Health approves hepatitis C drug telaprevir

Published on July 26, 2014 at 6:23 AM · No Comments

The Chemistry, Food & Drugs Division of the Trinidad & Tobago Ministry of Health approved the introduction of Telaprevir to the market, an innovative therapy that significantly increases the cure rate from Hepatitis C, and it is indicated for patients infected with the genotype 1 virus. Telaprevir is available in Trinidad under the trade brand INCIVO®.

Clinical studies show that the regimen of the treatment based in Telaprevir together with pegylated interferon + ribavirin increases the percentage of patients that get cured in up to 80% of the cases, significantly superior to the efficacy rates observed with the conventional treatment with dual therapy, available today.

Furthermore, triple therapy with the inclusion of Telaprevir avoids the progression of the illness, the need of a liver transplant, and the prevalence of long term complications, such as hepatic cirrhosis, liver cancer, and even death.

Hepatitis C is one of the most prevalent illnesses throughout the world. It affects around 170 million people. In its chronic phase, it is considered by the World Health Organization, as a "viral bomb", and it may have severe consequences on the patients and the public health systems.

Approximately 70% – 80% of the people with the illness do not know about it, due to the fact that symptoms present in advanced stages of the illness. Reason why it is extremely important to maximize the early diagnosis with new therapies which increase the possibility of getting cured.

Clinical manifestations of the infection by the Hepatitis C virus vary according to the acuteness or chronic phase of the illness. An acute infection is in most of the cases asymptomatic and it leads to a chronic infection in 80% of the cases. Of these patients, 20% develop hepatic cirrhosis, which is the previous step to hepatic failure. Of these 20%, from 3% to 5% develop liver cancer.

Not treating the illness may lead to complications that in an important number of patients may lead to the necessity of a liver transplant. The transplant has additional complications of serious considerations, such as the availability of the organs, the high costs associated to it and the required post-transplant care. This may have severe consequences for the patients as well as for the public health systems.

The paradigm of the Hepatitis C treatment has changed, above all, starting with the arrival of therapeutic alternatives that directly attack the virus, increasing cure rates. We are facing a new era. Medications that change the regimen of treatment and management of Hepatitis C with higher cure rates in patients infected with HCV (Hepatitis C Virus) genotype 1, which is most predominant genotype in our environment and the most resistant to treatments.

The main goal of the Hepatitis C treatment is to accomplish a sustained viral response (SVR); this means that the virus remains undetectable in the patient´s blood (known as undetectable viral load) six months after finishing the treatment[3]. The patients that achieve an SVR are considered cured.

Telaprevir is part of the Direct-Acting Antivirals (DAAs), which are medications directed to specific enzymes to block important stages of the Hepatitis C virus replication. The DAAs have the potential to help the patients achieve a sustained viral response (SVR).

Telaprevir is a protease inhibitor that is used for only 12 weeks, in all cases, offering this way, a short duration treatment for the patients.

This new therapeutic alternative, presented by the pharmaceutical laboratory Janssen, offers the possibility of shortening the treatment to half the time (with interferon + ribavirin), in 6 to 7 of every 10 patients. It is important that the management of the triple therapy (protease inhibitor as Telaprevir + interferon and ribavirin) is in the hands of experienced doctors in liver diseases.

The importance of the diagnosis

Since this is a treatable and curable illness in many cases, it is crucial to put personal emphasis in the request of an Hepatitis C detection test, for which is necessary to work more as a team with the clinical doctors and increase the awareness of this public health necessity. Once the infection is diagnosed, the patient should be referred to the specialist for him to evaluate the integrated approach and the needed treatment.

Part of the difficulty in the diagnosis generates in the fact that it is a highly asymptomatic illness or with vague symptoms, such as tiredness and fatigue.

Populations that are in high risk of bearing the virus, exist: intravenous drug users (current or previous), people with conditions associated with high prevalence of HIV, patients with hemophilia that received blood transfusions before 1992, people that have been in hemodialysis, people with elevated transaminases, transfusion receptors or organ transplants before July 1992, children of mothers with Hepatitis C, sexual partners of people with Hepatitis C and health personnel.

Source:

Janssen

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