Hepatitis A, B, C, D, B/D treatment in Germany

The main areas of specialisation are viral hepatitis A, B, C, D and E, congenital and autoimmune liver diseases, liver cirrhosis and its complications, liver transplantation (together with the transplant departments), and cancers of the gastrointestinal tract, liver, biliary tract, pancreas and endocrine glands.

Hepatitis C treatment in Germany

Hepatitis C is not a disease that affects only drug users and other high-risk groups. Infection with the hepatitis C virus, which is usually transmitted through blood, can occur in ordinary people at the dentist's, during a blood transfusion and even in a nail salon. Today it can be said with confidence that hepatitis C is not a death sentence: the hepatologists we work with prescribe drug therapy for chronic hepatitis C after comprehensive hepatitis C diagnostics (determining the virus type, viral load, antibodies, hormones and so on).

Comprehensive hepatitis C diagnostic programme in German clinics (cost — from 1850 euros):

• detailed blood tests (full blood count, biochemistry, liver serology, hormone profile, electrolyte and vitamin levels, coagulation, lipid panel, alpha-fetoprotein);
• liver function tests (ALT and AST levels; if the clinical findings point to acute viral hepatitis and the AST and ALT levels are raised out of proportion to alkaline phosphatase, it is necessary to perform viral serology (IgM anti-HAV, HBsAg, anti-HCV);
• PT/INR measurement;
• liver immunogenetics — genotyping and quantitative PCR of the causative virus;
• ultrasound of the abdominal organs and Doppler ultrasound of the hepatic vessels.

A liver biopsy is usually not required, but when it is performed it generally shows similar histopathology regardless of the specific type of virus. One of the main aims of the work-up is to confirm the diagnosis of hepatitis and to identify the genotype of the virus, which largely determines how long treatment lasts — anywhere from 6 to 12 months. Liver immunogenetics results take 2-3 weeks.

As a rule, hepatitis C treatment in Germany begins 1-2 weeks after the tests have been completed; this stage lasts about 12 days and costs approx. 2000 euros. Medication costs are around 1300 euros per month.
Hepatitis C treatment aims to eliminate the virus from the body with antiviral drugs. This halts the inflammatory process in the liver and prevents liver disease – cirrhosis or cancer – from developing. The success of hepatitis C treatment depends, among other things, on the genotype of the virus. In Europe the most common type is genotype 1; genotypes 2 and 3 are also frequent. Genotype 1 strains are the most difficult to treat.
Conventional treatment

Until recently the classic regimen for hepatitis C was combination therapy with long-acting interferon (peginterferon) and ribavirin. Unfortunately, this treatment does not work in every patient. A response is achieved in half of patients with genotype 1 and in almost 80% of those with genotypes 2 and 3. In addition, not all patients tolerate interferon well and they often have to interrupt therapy because of severe side effects.

Conventional methods involve fairly long and exhausting therapy. Treatment can last up to 1.5 years, during which the patient has to take tablets containing the active substance ribavirin twice a day. The course also involves weekly injections of the hormone interferon, which activates the immune system to fight the virus. Recovery can only be confirmed by a negative virus test performed 12 weeks after the end of treatment. It should be noted that this form of therapy is effective in roughly 50% of cases and can have quite serious side effects.
Promising treatments for hepatitis C

New drugs for the treatment of hepatitis C

In recent years new direct-acting antiviral drugs (DAAs) have come onto the hepatitis C market. These drugs interrupt the life cycle of the virus in different ways.

In clinical trials the new medicines showed significantly higher efficacy, fewer complications and shorter treatment times than conventional therapy. During the trials the medicines cleared hepatitis C in more than 90% of the patients taking part.

Some of these medicines are still combined with the classic interferon and ribavirin regimen, but a number of drugs can already be taken without interferon, which means that the side effects caused by interferon are avoided.

Sofosbuvir (Sovaldi®)

Sovaldi is approved for the treatment of patients with chronic hepatitis C of all genotypes in combination with interferon and other drugs.

European Medicines Agency recommendations:

• the sofosbuvir + ribavirin + peginterferon combination is recommended for patients with chronic hepatitis C of genotypes 1, 3, 4, 5 and 6 (12 weeks);
• the sofosbuvir + ribavirin combination is recommended for patients:
  with genotypes 1, 3, 4, 5 and 6 who are intolerant of interferon or have contraindications to it (24 weeks);
• with genotype 2 (12 weeks);
• with genotype 3 (24 weeks);
• awaiting a liver transplant (until transplantation).

Sovaldi is also combined with other new-generation drugs: simeprevir and daclatasvir.

Simeprevir (Olysio®)

Approved for the treatment of hepatitis C genotypes 1 and 4.

Simeprevir is used mainly together with peginterferon and ribavirin for 24-48 weeks, with simeprevir itself taken only during the first 12 weeks.

In selected cases, when a patient who needs urgent treatment tolerates interferon poorly or has contraindications to it, therapy is given without interferon. In this case simeprevir is taken together with sofosbuvir (with or without ribavirin).

Daclatasvir (Daklinza®)

Approved for the treatment of genotypes 1-4 in combination with sofosbuvir, without interferon. Depending on the patient's individual situation, therapy lasts from 12 to 24 weeks. In some cases additional ribavirin is required.

Clinical trials have shown that in combination with Sovaldi an SVR (sustained virological response) is achieved in all patients without exception, even in those with liver fibrosis.

Harvoni®: sofosbuvir + ledipasvir

For the first time two hepatitis C drugs have been combined in a single tablet – Sovaldi and the new drug ledipasvir.

Approved for the treatment of chronic hepatitis C genotypes 1 and 4, regardless of whether the patient has had previous therapy. The tablet is taken once a day for 8, 12 or 24 weeks, with or without ribavirin (twice a day). Additional interferon is not required. The duration of therapy and the addition of ribavirin depend on the genotype of the virus, the stage of liver disease and previous treatment.

In these genotypes the combination tablet can also be taken in decompensated cirrhosis. Under certain conditions the drug can be used to treat genotype 3 – if the patient has already been diagnosed with cirrhosis and/or previous therapy has failed.

Hepatitis D treatment in Germany

A breakthrough in the treatment of hepatitis delta

MYR Pharmaceuticals, a German biotechnology company specialising in the development and commercialisation of therapies for chronic hepatitis B and D, has announced the successful launch of HEPCLUDEX® (bulevirtide) in Germany, France and Austria.
On 31 July 2020 HEPCLUDEX® received authorisation from the European Commission as the first medicine approved in Europe for the treatment of adult patients with chronic hepatitis delta virus (hepatitis D virus) infection and compensated liver disease.

About HEPCLUDEX® (INN = bulevirtide)

HEPCLUDEX® is the first approved medicine for the treatment of chronic hepatitis D in Europe. HEPCLUDEX® blocks the NTCP receptor on the surface of hepatocytes and prevents the hepatitis B virus (HBV) and the hepatitis D virus (HDV) from entering hepatocytes and spreading within the liver. HEPCLUDEX® has been granted orphan drug status for the treatment of HBV infection by the European Medicines Agency (EMA) and by the US Food and Drug Administration (FDA). HEPCLUDEX® has been accepted into the PRIority MEdicines (PRIME) programme of the European Medicines Agency and has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA).

About hepatitis delta

Chronic hepatitis delta is the most severe form of viral hepatitis in humans and is caused by infection with the hepatitis delta virus (HDV). Hepatitis D occurs only as a co-infection in people infected with the hepatitis B virus (HBV). Co-infection leads to more serious liver disease than infection with HBV alone and is associated with faster progression of liver fibrosis, liver cirrhosis and decompensated liver cirrhosis, and with an increased risk of liver cancer and liver failure.

To order HEPCLUDEX® or any of the hepatitis medicines listed below from Germany, please contact us by e-mail or through any of the messengers you can see in the bottom right-hand corner of the page.

Baraclude (entecavir) 0.5 mg
Essentiale Kapseln 300 mg
Entecavir 0.5 mg; 1 mg
Epclusa 400 mg/100 mg
Harvoni 45 mg/200 mg
Hepatect CP 50 I.E./ml*
Lamivudine 100 mg
Maviret 100 mg/40 mg
Pegasys 180 µg; 135 µg
Revolade (eltrombopag) 50 mg; 25 mg
Ribavirin 400 mg
Tenofovir disoproxil 245 mg
Zepatier 50 mg/100 mg
Zeffix 100 mg
Zutectra 500 I.E*
Vemlidy 25 mg
Viread 245 mg