Hepatitis D Treatment in Russia: What You Need to Know About Accessing Breakthrough Therapy

Why Hepatitis D Requires Immediate Action

Hepatitis D is a satellite virus that can only replicate when Hepatitis B virus (HBV) is present. This makes HBV/HDV coinfection the most severe form of chronic viral hepatitis, where every week counts.

 

According to data published in the Journal of Hepatology, approximately 12 million people worldwide live with chronic Hepatitis D. The highest rates are found in Eastern Europe, Central and Western Asia, the Middle East, and certain parts of Asia.

 

 

HBV/HDV coinfection causes the fastest progression of liver scarring (fibrosis). Studies show that 60-70% of patients develop cirrhosis within 5-10 years, and the risk of liver cancer is three times higher than with Hepatitis B alone.

 

Every patient with confirmed Hepatitis B (detected by the HBsAg marker in blood) should be regularly tested for Hepatitis D antibodies (anti-HDV IgG). This blood test (typically using ELISA) shows whether your body has encountered the Hepatitis D virus. If positive, the next step is a more precise PCR test to determine whether active Hepatitis D virus (HDV RNA) is present in your blood and requires treatment.

 

Clinical guidelines from the Russian Ministry of Health and EASL (European Association for the Study of the Liver) international protocols require anti-HDV IgG testing for all patients with confirmed Hepatitis B surface antigen (HBsAg). Initial screening is recommended once at diagnosis, with follow-up testing prescribed individually based on risk factors or signs of disease progression.

 

Hepatitis D Diagnosis Involves Two Steps:

• Anti-HDV (IgG) antibody screening – shows whether you've been exposed to the virus
• HDV RNA PCR test – confirms active infection

 

Research shows that implementing reflex testing, where a positive anti-HDV result automatically triggers a PCR test for active infection, led to a fivefold increase in HDV detection among Hepatitis B patients. It's crucial to understand that every Hepatitis B patient should undergo regular Hepatitis D screening, since superinfection can occur at any time. Delays in diagnosis and treatment are dangerous, worsening your prognosis and wasting precious time. Waiting and hoping that therapy will become available in your country could lead to irreversible health consequences. Deciding to seek treatment today is an investment in your future.

Breakthrough Treatment: Bulevirtide (Myrcludex B/Hepcludex)

For years, the treatment standard was pegylated interferon-alpha, which had only a 10-25% success rate and caused severe side effects. One of the most promising recent developments in Hepatitis D therapy is bulevirtide (Myrcludex B/Hepcludex), developed by Professor Stephan Urban at Heidelberg University. Preclinical and clinical studies were conducted in Russia by Gepatera, which received the development transfer from German company MYR Pharmaceuticals and began the first clinical trials of Myrcludex B/Hepcludex in 2012.

How Bulevirtide Works

Bulevirtide is the world's first viral entry inhibitor. It blocks the NTCP receptor on liver cells (hepatocytes), preventing Hepatitis B and D viruses from entering.

Proven Effectiveness

Results from five clinical trials of bulevirtide demonstrated effective prevention of liver cell infection by Hepatitis D virus, shown through reduced viral loads and decreased inflammation. Most patients (67%) showed normalization of ALT (alanine aminotransferase, a key liver enzyme whose blood levels rise when liver cells are damaged).

 

Importantly, the biochemical response was sustained beyond 48 weeks, unlike with alpha-interferon.

 

A key study demonstrated bulevirtide's advantage: after 48 weeks of treatment alone, 45% and 48% of patients in the 2 mg and 10 mg groups respectively achieved virological response, compared to just 2% in the delayed treatment group.

 

Data published in the Journal of Hepatology in 2024 confirm that the longer bulevirtide therapy continues, the better the results. By week 96 of treatment: 79% of patients achieved virological response (undetectable virus). 64% of patients achieved biochemical response (normalized liver markers). Even patients with weak initial response had high chances of success: 43% of non-responders at week 24 and 82% with partial response ultimately achieved viral suppression by week 96.

 

When combined with pegylated interferons, bulevirtide can sometimes lead to viral elimination. Accumulated clinical data confirm that in some patients, bulevirtide therapy achieves viral control and creates conditions for functional cure of Hepatitis B, especially with combination therapy using pegylated interferons.

Safety Profile

Side effects were mostly mild, with no serious adverse events related to bulevirtide. The most common side effect is elevated bile acid levels in the blood, which is asymptomatic in most cases, only 10% reported mild and temporary itching.

Russia: Pioneer in Bulevirtide Access

Russian scientists led the way in studying and conducting clinical trials of the drug, from the initial concept through the entire complex registration process. As early as 2016, a research group published an article in the Journal of Hepatology describing the first results of bulevirtide therapy. Russia was among the first countries in the world to approve the drug in 2019 under the trade name Myrcludex B. This made therapy available to Russian patients several years before most other countries. In 2020, bulevirtide received conditional marketing authorization in Europe under the trade name Hepcludex, and in July 2023 received full marketing authorization.

 

Key Advantages of Treatment in Russia

Advantage 1: Expertise of Russian Physicians

Russian clinics have one of the world's largest bodies of practical experience with bulevirtide, beginning in 2020. Russian hepatologists actively publish clinical observations and participate in international research, giving them one of the world's largest real-world clinical practice datasets. Patients in Russia receive treatment from specialists with both theoretical knowledge and actual therapy experience.

 

Advantage 2: Competitive Treatment Costs

The financial aspect is a critical barrier for most patients. An annual course of Hepcludex in EU countries can cost up to €163,000 per year. The current cost of bulevirtide (Myrcludex B) treatment in Russia is approximately 142,000-173,000 rubles per monthly package, equivalent to about 1.7-2 million rubles for a complete treatment course lasting at least 48 weeks (approximately one year). For foreign patients, the total cost of a complete treatment course is 87-90% lower than in the EU. This transforms cutting-edge therapy from an impossible dream into a real opportunity to preserve your health and extend your life.

 

Advantage 3: Streamlined System for International Patients

The patient care system minimizes stress and organizational difficulties for medical tourists:

1. Remote consultation: Send existing test results (HBsAg, anti-HDV, HDV RNA by PCR, blood chemistry, elastometry results (FibroScan)) for preliminary evaluation.
2. Document processing: The clinic issues an official invitation for obtaining a medical visa.
3. Complete diagnostics in Russia: Comprehensive examination using expert-class equipment for final diagnosis confirmation and personalized therapy protocol development.
4. Treatment initiation and monitoring: After medication is prescribed and your condition stabilizes, you receive continuous remote supervision from your treating physician in Russia.
5. Full service: Transfer organization, professional interpreter services, and comfortable accommodations.

Leading Russian Clinics Offering Treatment

Hepatitis D treatment using bulevirtide is available at leading federal medical centers in Russia with the necessary licenses and expertise, including:

• European Medical Center (EMC) – an international clinic with over 600 specialists from the USA, Western Europe, Israel, and Russia.
• MEDSI – a network of clinical diagnostic centers equipped with modern equipment for diagnosing and treating liver diseases.

All these medical institutions operate according to international protocols and hold the necessary licenses for conducting bulevirtide therapy.

Frequently Asked Questions (FAQ)

How long does treatment last?

The standard initial course of bulevirtide therapy is 48 weeks. However, treatment duration is determined individually based on virological response. Studies show that effectiveness continues to improve when therapy extends to 96 weeks. At the physician's discretion, therapy may be extended to consolidate results and achieve maximum clinical benefit.

What are the risks and side effects?

Bulevirtide has a favorable safety profile, with mainly mild side effects and no serious adverse events associated with the drug. The most common side effect is elevated bile acid levels in the blood, which is usually asymptomatic. Injection site reactions are possible but typically minimal and don't require stopping treatment.

 

How should I prepare for examinations and treatment?

– Before arrival: Gather all available medical reports and test results (especially key HDV and HBV markers).

– For diagnostics in Russia: Blood tests require fasting (8-12 hours). Avoid alcohol and fatty foods for 2-3 days before examinations. For elastometry (FibroScan), don't eat for 4-6 hours before the procedure.

– Bring a list of all medications you're currently taking.

– Documents:

• International passport
• Medical documentation with Russian translation (the clinic can arrange translation if needed)

 

Do I need to speak Russian?

No. Leading Russian clinics working with international patients provide professional medical interpreter services. Many physicians speak English. The entire process, from initial consultation to discharge, can proceed in your native language or English.

 

Can I continue treatment at home after starting therapy in Russia?

Yes. After therapy begins and your condition stabilizes, you can return home and continue treatment under remote supervision from your Russian physician. The medication is administered subcutaneously once daily, and patients typically master the self-administration technique quickly. Regular blood monitoring can be done at a laboratory near you, with results sent to your treating physician.

 

Your Health Is in Your Hands

Hepatitis D is no longer a death sentence. Bulevirtide has opened a new era in treating this disease, and Russia offers a unique combination of factors for international patients:

✓ Earliest access to innovative medication – since 2019
✓ Extensive clinical experience – over 5 years of real-world practice
✓ Highly qualified specialists – participating in international research
✓ Competitive costs – 87% lower than in Europe
✓ Comprehensive organization – from visa to follow-up care

Every day of delay in treating Hepatitis D increases the risk of irreversible liver damage. Taking care of your health today means giving yourself a chance for a full life tomorrow.