Multaq FDA : The optimal duration of treatment with the oral nucleoside analogues is not known. Most doctors will probably anticipate giving these for at least one year. If at the end of a year of treatment there is loss of blood HBeAg (and rarely also HBsAg), treatment is considered a success and the drug may be stopped. However, this is achieved in only a minority of patients. Many more patients will have suppression of viral replication as assessed by undetectable blood viral DNA while taking the drug. But when the drug is stopped in most of these patients, viral replication will begin again and blood DNA will again be detectable. It is not clear if treatment in such patients should be maintained for another year, for several years, or for life, or if a different nucleoside analogue should be tried. It is also not known if prolonged treatment with nucleoside analogues will slow the progression of fibrosis, prevent hepatocellular carcinoma, or prolong life. Many doctors feel that at least patients with significant inflammation and/or fibrosis on liver biopsy, and possibly those with higher blood viral DNA levels, should be treated for the long term. However, the safety and efficacy of treatment with lamivudine, entecavir, or adefovir for hepatitis B for more than one year has not been firmly established. An informed patient and a hepatolo- gist should together make a decision about long-term duration of treatment with nucleoside analogues, with an understanding that all of the answers regarding efficacy and safety are not yet in.
Some patients with chronic hepatitis B will have a flare in liver inflammation as indicated by an elevation in blood ALT activity during treatment. This flare may paradoxically be associated with loss of HBeAg, resulting from the immune system being stimulated to destroy the virus-infected liver cells. Therefore, if a sudden rise in ALT activity occurs during treatment in an individual with chronic hepatitis B, therapy may be cautiously continued unless evidence of worsening liver function or failure is detected. A flare in inflammatory activity could also represent development of resistance to the drug, in which case the blood viral DNA will usually increase. And a flare in inflammatory activity could always indicate another problem or perhaps even a rare adverse event to the drug. It is therefore critical that a physician experienced in the medical treatment of chronic hepatitis B assess the patient very carefully to determine if the drug should be continued or stopped.
Who is more likely to respond to treatment for chronic hepatitis B? A shorter duration of infection correlates to a better chance of response. Therefore, individuals from countries where hepatitis B virus infection is endemic and who were likely infected at birth or in early childhood are less likely to respond. People infected as adults and who have been infected for less than three years usually have the best response. Younger patients are more likely to respond than older patients. Patients without cirrhosis will respond more often than those with cirrhosis; however, patients with greater inflammation on biopsy may surprisingly respond better than those with minimal inflammation.
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Interferon alpha and peginterferon alpha are administered by subcutaneous (under the skin) or intramuscular (into the muscle) injections. Most patients self-administer injections with small syringes similar to those used by diabetics to inject insulin. Most people choose to inject the interferon into the thigh; however, other areas such as the abdomen can also be injected. Patients should obtain brief training from a doctor or nurse before beginning self-injections.
Interferon alpha treatment for chronic hepatitis B is for sixteen weeks, with injections every day or three days a week depending on the dose. Peginterferon alpha treatment generally is for forty-eight weeks with injections once a week. Because low blood counts are a side effect of interferon alpha, patients should have their blood drawn and complete blood counts and platelet counts checked as their doctor instructs them after treatment has begun. ALT activity, bilirubin concentration, and albumin concentration should also be checked periodically during therapy. Patients should probably be seen by their doctors, or a nurse, at least once a month during treatment and instructed to contact their doctor if they experience side effects.
The most common and potentially serious side effects of interferon alpha and peginterferon alpha are low neutrophil counts and low platelet counts. Neutrophils, also called granulocytes, are a particular type of white blood cell important in fighting bacterial infections. Platelets are blood cells involved in clotting that may also be low in individuals with cirrhosis. As mentioned, patients should have their blood counts monitored during treatment with interferon alpha. If the neutrophil or the platelet count falls below certain levels, the dose of interferon alpha may have to be temporally reduced or the drug may even have to be discontinued.
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There are many other side effects of interferon alpha and peginterferon alpha therapy beside low blood counts. The most common is development of flu-like symptoms. These can be quite disabling and include fever, cold sweats, shaking chills, muscle aches and pains, and joint aches and pains. Flu-like symptoms are usually worse near the start of treatment and less common later in the course of therapy. To help tolerate mild to moderate flu-like symptoms, I generally recommend that patients inject the interferon about an hour before going to sleep and take acetaminophen just before injecting the interferon. The acetaminophen will provide some relief from symptoms and, if taken at bedtime, possibly help the patient to sleep through the side effects. Flu-like symptoms rarely require stopping treatment, but on occasion they are so intolerable that there is no other option.
Interferon alpha and peginterferon alpha can aggravate diabetes mellitus and thyroid disorders. Patients with diabetes mellitus who are treated with interferon alpha should carefully monitor their blood sugars. Patients with thyroid disease—and possibly all treated patients— should have blood tests for thyroid function checked periodically during treatment. Significant abnormalities in blood sugar or thyroid tests may necessitate stopping treatment.
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