Telbivudine, which is often marketed in the US as Tyzeka, is a thymidine nucleoside analog which targets the hepatitis B virus. Clinical trials have suggested that it is significantly more effective than other hepatitis treatments such as adefovir or lamivudine, and is much less likely to cause resistance. It is approved by the FDA and marketed across the world by the Swiss pharmaceutical company Novartis.
This medicine impairs the HBV (hepatitis B) virus by impairing DNA replication, which leads to chain termination. This prevents the virus from recreating in the body, stopping it from infecting new liver cells. As a synthetic nucleotide, it differs from the natural only in respect of the location of the base and sugar moieties.
Although this medication treats the symptoms of hepatitis, it will not actually cure the illness, meaning that it may not be effective in preventing complications related to hepatitis B such as liver cancer or cirrhosis of the liver - nor will it prevent the transmission or spread of hepatitis B to other people via blood transfusion, sexual contact or sharing needles. It is only designed for use in people who are at least 16 years of age.
Patients undergoing treatment with Telbivudine may experience some unwanted side effects along with the desired effects of the medicine. The most common side effects experienced include: chills, coughing, fever, diarrhea, a general feeling of illness or discomfort, pain in the joints, headaches, appetite loss, muscle ache, runny nose, nausea, shivering, stomach pain, sore throat, difficulty sleeping, excess sweating, vomiting, and/or unusual weakness or tiredness.
As the patient continues to take the Telbivudine as directed by a physician, the side effects mentioned above should lessen or even disappear completely. If these side effects continue to affect the patient, or get worse over time, the patient is advised to contact their doctor immediately.
The majority of patients taking this medication only experience minor side effects, if any at all, and most healthcare professionals are of the opinion that the benefits of Telbivudine far outweigh the negatives of minor side effects.
In some instances, some patients experience additional side effects. Although these are experienced rarely, they are common enough to warrant mentioning. These effects include: chest pain, back pain, muscle cramps, tenderness, pain in the extremities, swollen joints, difficulty moving/decreased motor skills, indigestion, stomach upset, a burning sensation in the chest/stomach, dark-colored urine, sleepiness, shortness of breath, fast or shallow breathing and/or a decreased appetite.
Many of these side effects will not require medical attention, although patients who are experiencing ongoing minor discomfort should consider contacting a healthcare professional who may be able to advise them on ways to alleviate certain symptoms, via changes in the diet or over the counter remedies, for example.
Because Telbivudine can affect movement, patients who are undergoing initial treatment with this medication are advised to refrain from driving or operating any heavy machinery until it has been observed that the medicine does not incapacitate them in any way, shape or form. Following this, a doctor will be able to advise on whether it is safe for the patient to drive without putting themselves or other road users at risk.
In clinical studies, Telbivudine has generally been tolerated well. Most of the side effects have been described as mild or moderate. It is therefore a preferred antiviral medication for the treatment of hepatitis B.
Telbivudine is taken orally. The ovaloid-shaped tablets are film-coated and a white to slightly-yellowish color in appearance, with LDT printed on one side.
Because of higher resistance rates which can develop with long-term treatment among hepatitis patients with incomplete viral suppression, treatment with this medicine should only be initiated when pre-treatment HBV DNA and ALT measurements are understood in these patient populations:
HBV DNA levels must be monitored after 24 weeks of treatment to make certain that complete viral suppression (where HBV DNA is less than 300 copies per mL) has taken place. Patients who have detectable HBV DNA 24 weeks after treatment should have an alternate therapy initiated by their doctor. The optimal therapy should be ascertained by further testing of resistance.
For patients living with chronic hepatitis B, the recommended treatment dose is 600mg of Telbivudine once a day, taken orally. This medication can be taken with or without food, although healthcare professionals recommend taking the medication with a glass of water. Telbivudine capsules or tablets should be swallowed whole, as opposed to swallowed or chewed. An oral solution is available (in 30mL increments) for patients who have difficulty swallowing tablets.
Although the manufacturers of Telbivudine provide general dosage instructions on the literature provided with the medication, it should be reiterated that this recommended dose may be adjusted at the discretion of the patient's doctor dependent on various factors, including the physiology of the patient and the current rate of infection. Patients should take Telbivudine as directed by their health care provider only. There is no recommended dose for patients under 16. In the event of a minor undergoing treatment with Telbivudine, the dose should be decided by the doctor overseeing treatment.
Patients undergoing treatment with Telbivudine should have their HBV DNA monitored at least every 6 months in order to assure a continual response. If at any point the patient tests positive for HBV DNA, alternate treatment should be initiated. The optimal treatment duration for hepatitis B patients using Telbivudine is currently unknown.
If a patient currently undergoing treatment with Telbivudine accidentally misses a dose, the official advice is to take the missed dose as soon as he or she remembers. However, if it is nearly time for the next dose to be administered, the patient should skip the missed dose and continue to take the medication as per the usual dosing schedule. Patients are advised against taking a double dose to make up for a missed one, as this creates the potential for overdose or potentially harmful side effects.
In the event of an overdose (on Telbivudine or any other medication), patients are advised to contact their local poison control center immediately on 1800-222-1222. If the patient has collapsed, is unconscious or is having difficulty breathing, caregivers, friends or relatives are advised to contact emergency services on 911.
Medications have the potential to interact with other drugs or chemicals in the human body, potentially changing the effects of each medicine. In some instances, this can cause a medication to become ineffective in treating the condition it has been prescribed for. In other circumstances, drugs can interact and cause unwanted side effects which can be potentially harmful or even fatal. Because of the potential for this to happen, patients are advised to always keep a detailed list of all medications they are currently taking, including the frequency and dosage of each drug. This applies to over the counter medicines, vitamins and herbal supplements as well as prescribed medications.
Below is a list of drugs known to interact negatively with Telbivudine. Patients who are currently undergoing treatment with any of the following medications are urged to notify their doctor before taking the first dose of Telbivudine:
Telbivudine use can cause life-threatening damage to the liver, as well as a condition called lactic acidosis, which is a build-up of acid in the bloodstream. Obese people, females and those with prolonged exposure to nucleosides may be at increased risk of this condition.
In some instances, cases of muscle problems and wastage has been reported in patients during the initial weeks and months of treatment with Telbivudine. Muscle breakdown can eventually lead to kidney damage, therefore it is important for patients who experience any form of myopathy to notify their physician immediately, who may consider implementing alternate treatments in conjunction with or in place of Telbivudine.
Nerve problems have been reported by a number of patients taking Telbivudine, in particular those who are currently undergoing treatment with drugs which are administered intravenously. Those who take Telbivudine along with injectable interferons may experience problems such as continued numbness, burning, tingling sentations in the extremities (peripheral neuropathy) and/or difficult walking. Under these circumstances, patients are advised to contact their healthcare provider as soon as is feasibly possible.
Patients who have ever suffered from scarring of the liver (cirrhosis) or any other liver disease (apart from hepatitis B) should notify their doctor prior to commencing treatment with this medicine. Additionally, patients are advised to tell their doctors if they are currently or regularly engaging in activity that may impair liver function (such as recreational drug use or excess alcohol use). This is because impaired liver function may affect the efficacy of Telbivudine or cause doctors to presume Telbivudine is not working at its current dose if they are not aware of any potentially liver-damaging activities the patient currently partakes in.
Patients should never stop taking Telbivudine without informing their doctor, as abruptly ceasing treatment with this medicine can cause hepatitis to worsen drastically. Patients are therefore advised to refill their prescription at least five days prior to expecting to run out of their current supply. Patients should also be committed to keeping all appointments with their doctor or qualified healthcare professional for monitoring before, during and after treatment with this medication. Patients can expect their doctor to order numerous tests to check the response of the body to Telbivudine during these periods, and this is not abnormal for someone undergoing treatment with the drug.
Telbivudine should be kept at room temperature. The manufacturer of this medication also recommends that the tablets should be sufficiently kept away from moisture, heat and direct sunlight - ideally in a locked medicine cabinet, to reduce the risk of children or other patients accidentally taking medication which has not been prescribed for them.
Treatment with Telbivudine typically lasts upwards of six months, however if the drug is no longer effective or the patient's doctor decides that it may be time for an alternate treatment, the patient should be aware of the preferred procedures for disposing of the remaining supply. Medications which are no longer required can, in most cases, be recycled or taken to a pharmacy where they will be disposed of in a safe and hygenic manner.
Telbivudine is indicated for the treatment of hepatitis B in patients who have compensated liver disease with evidence of viral replication, persistently high ALT levels and evidence of inflammation and/or fibrosis. Treatment with Telbivudine should only be considered by a doctor when the use of other antiviral medicines with higher genetic barriers to resistance are unavailable or otherwise inappropriate.
Treatment with this medication should only be initiated by a doctor with experience in the management of acute hepatitis B infection, and patients are advised to stick to the treatment guidelines as laid out by their physician or healthcare provider. This ensures the best possible outcome and prevents the patient from putting themselves at undue risk of harm.
When taken correctly, Telbivudine provides effective treatment of the symptoms of hepatitis B, providing the patient with the freedom to live a much more fulfilling and autonomous lifestyle. In order to get the most out of this medicine, patient and doctor need to work together in order to regularly monitor for changes before, during and after treatment with Telbivudine in order to ascertain the best course of treatment going forward. Although hepatitis B is currently incurable, medications such as Telbivudine provide patients with the means to live a normal, reasonably healthy lifestyle, provided they take the advice of healthcare professionals and make subtle improvements to diet and exercise regimens.