Telbivudine (Sebivo) - Uses, Dose, Side effects, MOA

Telbivudine (Sebivo) is an antiviral medicine that inhibits the reverse transcriptase responsible for viral replication. It is used in the treatment of chronic active hepatitis B infection.

Telbivudine (sebivo) Uses:

  • It is used in the treatment of chronic hepatitis B with evidence of viral replication and either persistent transaminase elevations or histologically-active disease.
  • Other drugs to treat hepatitis B include interferon, lamvudine, tenofovir, and tenofovir alafnamide.

Telbivudine (sebivo) Dose in Adults

Telbivudine dose in the treatment of chronic hepatitis B:

  • 600 mg orally once a day.
  • Treatment duration (AASLD practice guidelines):

    • The Treatment duration for nucleoside/ nucleotide analog-based therapy like telbivudine is variable.
    • It is influenced by HBeAg status, duration of HBV suppression, and presence of cirrhosis/decompensation:
  • Patients without cirrhosis:

    • Hepatitis B e antigen (HBeAg) positive immune-active chronic hepatitis:

      Treat until HBeAg seroconversion occurs
      • after seroconversion, a prolonged duration of therapy is mostly required in patients treated with nucleoside/ nucleotide analogs.
      • The optimal duration is unknown
      • however, consolidation therapy is generally a minimum of 1 year of persistently normal ALT and undetectable serum HBV DNA levels after HBeAg seroconversion.
    • HBeAg-negative immune-active chronic hepatitis:

      • Indefinite antiviral therapy is given unless there is a competing rationale for discontinuation (risk/benefit decision)
      • treatment discontinuation may be considered in patients with loss of HBsAg; however, there is insufficient evidence to guide decisions in these patients.
  • Patients with cirrhosis:

    • HBeAg-positive immune-active chronic hepatitis:

      • In patients who seroconvert on therapy, give antiviral therapy indefinitely due to concerns with decompensation and death, unless there is a strong competing rationale for discontinuation.
    • HBeAg-negative immune-active chronic hepatitis:

      • Discontinuation of treatment is not recommended because of the potential for decompensation and death
    • Viral breakthrough ( AASLD practice guidelines) :

      • Patients with confirmed viral breakthrough (HBV DNA ≥100 units/mL with previously undetectable levels [<10 units/mL] or >1 log increase in HBV DNA) should either be changed to an alternative antiviral monotherapy agent with a high genetic barrier to resistance or receive a 2nd antiviral agent with a complementary resistance profile

Telbivudine (sebivo) Dose in Children

Telbivudine dose in the treatment of chronic Hepatitis B: 

  • Adolescents ≥16 years:
    • Refer to adult dosing.

Telbivudine Pregnancy Risk Factor: B

  • The AASLD chronic Hepatitis B treatment recommendations for hepatitis B-infected pregnant women (not co-infected with HIV) recommend antiviral therapy to lower the risk of perinatal transmission in HBV-positive pregnant women.
  • Limited data are available on routine antiviral therapy to prevent perinatal transmission.
  • Patients with viral loads greater than 200,000 units/ml might benefit from treatment.
  • However, antiviral therapy is not recommended for patients with viral DNA less than 200,000 units/ml according to AASLD.

Telbivudine use during breastfeeding:

  • It is unknown if breast milk contains telbivudine.
  • Breastfeeding women with hepatitis B (not co-infected with HIV) should not be considered a contraindication.
  • Antivirals are rarely excreted in breast milk and are unlikely to cause any significant toxicities.
  • Mothers should inform their infants about the unknown risk of low-level infant exposure.
  • This is in addition to the lack of long-term safety data for infants born to mothers who were exposed to antiviral agents during breastfeeding.
  • According to the manufacturer breastfeeding during therapy should be considered in light of the risks to infants and the benefits to mothers.

Telbivudine Dose adjustment in patients with renal disease:

  • CrCl ≥50 mL/minute:

    • No dosage adjustment is required.
  • CrCl 30-49 mL/minute:

    • 600 mg every 48 hours given
  • CrCl <30 mL/minute (not requiring dialysis):

    • 600 mg given every 72 hours
  • End-stage renal disease (ESRD):

    • 600 mg given every 96 hours
  • Hemodialysis:

    • Administer after the dialysis session

Telbivudine  Dose in Liver disease

  • Adjustment in the dose is not required in patients with liver disease.

Common Side Effects of Telbivudine (Sebivo):

  • Central nervous system:

    • Fatigue
  • Neuromuscular & skeletal:

    • Increased creatine phosphokinase

Less Common Side Effects of Sebivo (Telbivudine):

  • Central Nervous System:

    • Headache
    • Dizziness
    • Fever
    • Insomnia
  • Dermatologic:

    • Skin Rash
    • Pruritus
  • Endocrine & Metabolic:

    • Increased Serum Lipase
  • Gastrointestinal:

    • Diarrhea
    • Abdominal Pain
    • Nausea
    • Abdominal Distension
    • Dyspepsia
  • Hematologic & Oncologic:

    • Neutropenia
  • Hepatic:

    • Increased Serum ALT
    • Increased Serum AST
  • Infection:

    • Exacerbation Of Hepatitis B
  • Neuromuscular & Skeletal:

    • Arthralgia
    • Back Pain
    • Myalgia
  • Respiratory:

    • Cough
    • Pharyngolaryngeal Pain

Contraindications to Telbivudine (sebivo):

  • Concurrent use of peginterferon alfa-2a
  • Hypersensitivity to telbivudine and any part of its formulation

Warnings and precautions

  • Lactic acidosis/ hepatomegaly:

    • With nucleoside analogs, severe hepatomegaly and steatosis with lactic acidosis have been reported. Some cases even proved fatal.
    • Many cases of postmarketing lactic acidosis were associated with other conditions (rhabdomyolysis and/or muscle-related events (eg myopathy, myositis); some cases were also seen in the context of pancreatitis/hepatic Steasis and renal failure.
    • Patients who have clinical or laboratory evidence of lactic acidosis or hepatotoxicity should not be treated.
  • Myopathy/rhabdomyolysis:

    • There have been reports of myopathy, myositis, and rhabdomyolysis, some with lactic acidosis.
    • Myopathy may be undiagnosed for several weeks or months after its initiation.
    • It is caused by undiagnosed muscle aches or weakness, in combination with serum creatine Kinase increases.
    • If myopathy or Rhabdomyolysis is suspected, interrupt therapy and stop therapy if it is confirmed.
    • Patients who take concomitant medication for myopathy should be closely monitored.
  • Peripheral neuropathy:

    • Peripheral neuropathy may occur either alone or with the combination of pegylated Interferon Alfa-2a (concurrent usage is contraindicated), or other interferons.
    • Within three months of the therapy's initiation, symptoms were evident.
    • Stop treatment of suspected peripheral neuropathy. If confirmed, symptoms can be reversed by discontinuing.
  • Chronic Hepatitis B: [US-Boxed Warning]

    • After discontinuation of treatment. An acute exacerbation may occur if hepatitis B is severe.
    • After stopping treatment, monitor liver function for several months. Restarting anti-hepatitis B therapy might be necessary.
  • Human immunodeficiency virus:

    • Telbivudine has no clinically relevant activity against HIV type 1.
  • Renal impairment

    • Patients with severe renal dysfunction or ESRD should be cautious. Dosing adjustments are required (CrCl 50 mL/minute).

Telbivudine (United States: Not available): Drug Interaction

Risk Factor X (Avoid combination)


Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine.

Interferon Alfa-2b

May enhance the adverse/toxic effect of Telbivudine. Specifically, the risk for peripheral neuropathy may be increased.

Peginterferon Alfa-2a

May enhance the adverse/toxic effect of Telbivudine. Specifically, the risk for peripheral neuropathy may be increased.

Peginterferon Alfa-2b

May enhance the adverse/toxic effect of Telbivudine. Specifically, the risk for peripheral neuropathy may be increased.


  • Liver function tests (eg, AST and ALT) should be checked periodically during therapy and for several months after the discontinuation of therapy
  • renal function before initiation and periodically during treatment
  • signs and symptoms of peripheral neuropathy (eg, weakness, paresthesia, leg pain) or myopathy (eg, unexplained muscle pain, tenderness, or weakness)
  • serum creatine kinase.
  • Chronic hepatitis B:

    • HBV DNA and ALT are usually done every three months until undetectable and then every 3 - 6 months thereafter
    • HBeAg
    • Monito for seroconversion (anti-HBe positivity in patients who are HBeAg positive)
    • HBsAg
    • consider monitoring creatine kinase and lactic acidosis if symptoms are concerning
    • monitor for peripheral neuropathy
    • following stopping, monitor for recurrent viremia, ALT flares, seroreversion, and clinical decompensation every 3 months for at least 1 year
    • Monito periodically for hepatocellular carcinoma especially in patients at high risk.

How to administer Telbivudine (Sebivo)?

  • May be administered without regard to food.

Mechanism of action of Telbivudine (Sebivo):

  • Telbivudine (L-enantiomer thymidine) is a synthetic thymidine nucleoside analog.
  • It is phosphorylated intracellularly into the active triphosphate version, which competes against the natural substrate, thymidine 5-'-triphosphate to inhibit hepatitis A viral DNA polymerase
  • It blocks the enzyme and inhibits reverse transcriptase activity, resulting in the inhibition of viral DNA replication.

Distribution: V :

  • > total body water

Protein binding:

  • ~3%


  • No metabolites detected

Half-life elimination:

  • Terminal: 40-49 hours

Time to peak, plasma:

  • 1-4 hours


  • Via Urine (~42% as unchanged drug)

International Brands of Telbivudine:

  • Ramenart
  • Sebivo
  • Telbihep

Telbivudine Brand Names in Pakistan:

Telbivudine 600 mg Tablets

Sebivo Novartis Pharma (Pak) Ltd
Telbivudine Cirin Pharmaceuticals (Pvt) Ltd.
Vizeka Wns Field Pharmaceuticals