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Despite the advances, Brazil is far from eradicating the hepatitis C virus

According to liver diseases expert Dr. Raymundo Paraná, the drugs delivered by the Unified Health System (SUS) have a high cure rate, as demonstrated in the Reference Centers experience, resulting in a cure rate greater than 90%


Brazil has made a huge effort, during times of crisis, to include new drugs for Hepatitis C treatment

Although being a severe health problem, the Hepatitis C virus is far from being eradicated in the Country. An estimate from over 1.5 million carriers, the diagnosis reaches less than 200 thousand patients, evidencing huge a gap between carriers and diagnosed patients. The vaccine, on the other hand, is extremely complex, since the regions targeted by the humoral immune response (hypervariable region in the envelope) is extremely mutable.  This way, the antibodies are not neutralizing as happens to other viruses, and thus, the vaccine against Hepatitis C will require greater complexity.

To giver more information about the subject, the BSTMs (Brazilian Society of Tropical Medicine) pressboard talked to liver diseases expert Dr. Raymundo Paraná, former chair at the Brazilian Hepatology Society, and that dedicated his life to liver diseases, especially viral hepatitis.

BSTM: What are the perspectives of eradicating the C virus in Brazil?

Dr. Raymundo Paraná: Brazil has made a huge effort to offer a high-cost treatment for Hepatitis C. Currently our Hepatology Reference Centers, still short in numbers, already treat a substantial number of hepatitis C patients. This aspect is much more favorable than what we had in the interferon era.

Despite these advances, Brazil is still far from eradicating the Hepatitis c virus. From an estimated 1.5 million virus carriers, we currently diagnose less than 200 thousand. This means a huge gap between hepatitis C carriers in the population and diagnosed patients.

Likewise, our therapy protocol, in a pragmatic fashion, defines treatment priorities for patients with more advanced diseases, therefore, patients with milder diseases will not be prioritized at this first moment. All these joint aspects reduce our chances to eradicate the Hepatitis C virus from 2030 to 2040, against the European and American expectations, which defines this decade as the end of the HCV.

BSTM: How do you perceive the advances in Hepatitis C treatment in Brazil?

Dr. Raymundo Paraná: I acknowledge the great efforts Brazil has put together, in times of crises, to add new drugs for Hepatitis C treatment. Surely, we use top-of-the-line drugs as Sofosbuvir, Daclatasvir and Semiprevir, and most recently, the 3D scheme. Other countries as the USA, Canada, and countries in Europe and Asia, already dispose a much more diverse therapy arsenal than what we have in Brazil. Besides this, we still have some difficulty regarding rescue therapy in non-responsive patients and more specific protocols for special populations.

Anyway, the drugs delivered by the Unified Health System (SUS) have a high cure rate and this fact has been demonstrated by experiences in Reference Centers, resulting in cure rates above 90%, including patients from unfavorable profiles, as the genotype 3 and cirrhotic patients.

BSTM: With the new treatment, Brazil reaches a 90% hepatitis C cure rate. Do you belive a 100% cure rate will ever be a reality? When?

Dr. Raymundo Paraná: It will surely be a reality. There are new therapy schemes being applied in other countries with much more ambitious proposals than ours and/or with rescue proposals for non-responsive patients. We have other drugs in evaluation phases. There is no doubt the Hepatitis C therapy will become very close to 100% in a short period.

BSTM: The Sofosbuvir and Simeprevir combination costs R$ 25,000 (~USD 8,500) and the Sofosbuvir/Daclatasvir combination costs R$ 24,000 (~USD 8,000). This means great part of Brazils population does not have financial conditions to the drugs. What has been done or what could be done for these people?

Dr. Raymundo Paraná: The two mentioned schemes are already available at the Unified Health System for hepatitis C patients with F3/F4 hepatic fibrosis and/or patients with extra-hepatic manifestations, co-infected by the HIV and those with renal impairment.

The therapy scheme arsenals also include the 3D scheme, whose results, especially for the 1b genotype is very good.

Treatment is available at the SUS according to the Clinical Protocols and Therapy Guidelines (CPTG). This, on the other hand, is not a consensus or an expert recommendation, since it is a public health policy. This way, not only scientific evidence must be considered, but the logistic aspects and the country`s budget. For this reason, the CPTG has some pragmatic rules that restrict the access, however prioritizing the patients who need the most. This is a public policy strategy.

Another option would be patients with health insurance being treated with supplementary health support. The bill 9656 from 1998 defined pharmaceutical coverage for health insurance companies dedicated solely and exclusively to hospital medications, what proves it is outdated. In 1998, some treatments used today were not even conceived. A classic example is oral chemotherapy, conducted at households and with a great success in cancer therapy. This treatment has already been acknowledged by health insurance coverage. I believe hepatitis C will follow this path, even because it is a high impact treatment due to its cure rate, excellent cost x benefit relation and easy handling.

Even with all these simplicity attributes, it is not possible to establish a law to define the treatment of a complex disease as hepatitis C in the same way it happens to ordinary diseases. This bill puts complex and simple treatments side-by-side. How to compare hepatitis C treatment to tonsillitis treatment?

This way, this law lacks revision for its temporal and scientific misrepresentations, as must also be suited to ensure the Unified Health System high-cost pharmaceutical assistance equity.

Currently, the UHS, for high-cost pharmaceutical assistance, provides treatment for the wealthier layers of the population. This severe trend towards the upper classes is due to patients who have health insurance and assistance, coming from private offices, have easier access to the required exams for pharmaceutical assistance (ECG, HCVRNA, Genotype, etc.). This shortcut does not match the UHSs equity policy.

BSTM: In Brazil, according to the Health Ministry, over 1 million people have hepatitis C. The UHS offers diagnostic and treatment against the disease. In your opinion, people have seeked this kind of service? Why?

Dr. Raymundo Paraná: In Brazil the rapid tests are broadly available, however, we still do not have enough capillarity to reach the entire population. This is due to several aspects, including the quality of Brazils medical formation that has trended towards a public policy that privileges numbers instead of quality.

The medical schools, generally speaking, do not have a medical formation proposition that allows performing basic assistance during low-complexity endemies. In addition, the lack of a career at the UHS discourages basic attention physicians and contributes to a great team volatility. This system disorganization overcrowds high-complexity systems with patients under simpler conditions and end up taking place of those with situations that are more complex.

I believe hepatitis C is a good picture for this moment our Country is in.

At the same time, the UHS requires a perfect harmony in relations between municipal, state and federal health systems. We all know this does not what happens in reality. This way, all physicians should require hepatitis C tests for patients over 45 years old, regardless of their specialty, but this is not commonplace. All municipal governments should offer rapid tests at their health centers, but they do not. All patients diagnosed with hepatitis C should have easy access to confirmation with HCV-RNA in the cities, but they do not. All patients should have evaluation in basic assistance to define those who require progression to medium and high complexity and those who would remain in basic attention, but this is not what happens. Therefore, what I mean is we are still very far from the ideal situation.

BSTM: In your opinion, why is there is yet no vaccine against hepatitis C?

Dr. Raymundo Paraná: The vaccine against hepatitis C is extremely complex, since the regions targeted by the humoral immune response in the host (hypervariable region of the envelope) is extremely mutable. This way, the antibodies are not neutralizing, as it happens to other viruses. A vaccine against hepatitis C will require greater complexity.

I think hepatitis C is a severe health problem in Brazil. In our Country, around 50% of the liver transplants are suggested due to hepatitis C. Around 70% of liver cancer cases are related to hepatitis C. This means we are diagnosing our patients too late. Similarly, there is a large amount of patients with hepatitis C and diabetes, which evolves quickly without a diagnostic tracking in this population.

There is still little information for physicians regarding hepatitis C diagnostic, whether for their hepatic manifestations or the numerous extra-hepatic manifestations. Not rarely, patients wander among professionals of different specialties with peripheral neuropathies, renal changes, and skin problems without being investigated for hepatitis C by these physicians. This is due to a deficient formation of our professionals for great diseases, as well as to some neglect towards hepatitis C.

Surely Brazil has made great advances combating viral hepatitis since 2003, but when we compare the efforts put on HIV control and treatment, we cannot compare to what happens with hepatitis C/B and D. Campaigns involving viral hepatitis are shallow, the media gives little attention to this problem as a severe public health issue and basic assistance is unable to offer a model that allows diagnostic and forwarding of these patients in a rational and fast way.…