Question

Mr. JJ has a prescription for interferon alfa in prefilled injection pens, 15 million units per mL available as 1.5-mL cartridges. He is 27-years-old and was an intravenous drug user for 9 years. He is well known to you, having been a frequent visitor to your pharmacy for some years. Mr. JJ is of slight build, 180 cm in height, weight 55 kg. He has been ?clean? for several months but has been in hospital recently due to serious health problems. Laboratory tests showed increased levels of serum alanine aminotransferase (ALT), antibodies to hepatitis- Be antigen (HBeAg), and DNA polymerase activity.

1. What is hepatitis B infection?
2. What are the risk factors for developing hepatitis B virus (HBV) infection?
3. How is HBV infection diagnosed?
4. How can hepatitis B infection be prevented?

b.    What is interferon alfa and how does it work in the management of HBV

infection?

c. What formulations of interferon alfa are available?

5. What additional treatments are used for chronic hepatitis B infection and how do they act?

6. How should interferon alfa treatment be monitored?

7. What additional advice should be given?

Answer 1

Hepatitis B is an infection of your liver. It can cause scarring of the organ, liver failure, and cancer. It can be fatal if it isn’t treated.It’s spread when people come in contact with the blood, open sores, or body fluids of someone who has the hepatitis B virus.

common symptoms include:- fatigue, dark urine, joint and muscle pain, loss of appetite, fever, abdominal discomfort, weakness, yellowing of the whites of the eyes (sclera) and skin (jaundice).

The most common ways/risk factor to get hepatitis B include:

1. Sex. You can get it if you have unprotected sex with someone who has it and your partner’s blood, saliva, semen, or vaginal secretions enter your body.
2. Sharing needles. The virus spreads easily via needles and syringes contaminated with infected blood.
3. Accidental needle sticks. Health care workers and anyone else who comes in contact with human blood can get it this way.
4. Mother to child. Pregnant women with hepatitis B can pass it to their babies during childbirth. But there’s a vaccine to prevent newborns from becoming infected.

diagnostic evaluation for Hepatitis B:

• Hepatitis B surface antigen and antibody (HBsAg). Antigens are proteins on the hepatitis B virus. Antibodies are proteins made by your immune cells. They show up in your blood between 1 and 10 weeks after exposure. If you recover, they go away after 4 to 6 months. If they’re still there after 6 months, your condition is chronic.
• Hepatitis B surface antibody (anti-HBs). These show up after HBsAg disappears. They’re what make you immune to hepatitis B for the rest of your life.
• If your disease becomes chronic, your doctor might take a tissue sample from your liver, called a biopsy. This will tell him how severe your case is.
• Liver function test are important in individuals with hepatitis B or any liver disease. Liver function test check your blood for the amount of enzymes made by your liver. High levels of liver enzymes indicate a damaged or inflamed liver.
• Hepatitis B e antibody (abbreviated anti-HBe) Anti-HBe usually signifies that virus replication has slowed down, but in some variants of hepatitis B, the virus continues to replicate at a rapid rate, and high levels of virus can be found in the circulation.
• Hepatitis B core antibody (abbreviated anti-HBc) Anti-HBc is usually present throughout the course of infection and stays in the blood after recovery. It is not present in people who have been vaccinated against hepatitis B.
• Hepatitis B DNA (abbreviated HBV DNA) HBV DNA is the genetic material found in the hepatitis B virus. HBV DNA usually disappears from the blood after a person recovers. HBV DNA is a measure of the concentration of virus in the circulating blood.

Prevention of Hepatitis B:-

The. Vaccination is highly recommended.

1. all infants, at the time of birth
2. any children and adolescents who weren’t vaccinated at birth
3. adults being treated for a sexually transmitted infection
4. people living in institutional settings
5. people whose work brings them into contact with blood
6. HIV-positive individuals
7. men who have sex with men
8. people with multiple sexual partners
9. injection drug users
10. family members of those with hepatitis B
11. individuals with chronic diseases
12. people traveling to areas with high rates of hepatitis B
13. Use condoms every time you have sex.
14. Wear gloves when you clean up after others, especially if you have to touch bandages, tampons, and linens.
15. Cover all open cuts or wounds.
16. Don’t share razors, toothbrushes, nail care tools, or pierced earrings with anyone.
17. Don’t share chewing gum, and don’t pre-chew food for a baby.
18. Make certain that any needles for drugs, ear piercing, or tattoos -- or tools for manicures and pedicures -- are properly sterilized.
19. Clean up blood with one part household bleach and 10 parts water.

b. It is a pharmaceutical drug composed of natural interferon alpha (IFN-α) obtained from the leukocyte fraction of human blood following induction with Sendai virus. Interferon alfa contains several naturally occurring IFN-α subtypes and is purified by affinity chromatography.

Hepatitis B. Interferon alpha-2b is the form of the drug that works against chronic viral hepatitis B infection.

action of interferon on hepatitis b Interferons are proteins that are secreted by the cells when the body is being attacked by a virus like hepatitis B, C, or D. Genetically engineered interferon, given by injection, stops the hepatitis virus from replicating itself and provides a boost to the immune system. Different forms of interferon are needed to treat hepatitis B, hepatitis C, and hepatitis D.

A person's cells begin secreting interferon when they detect viral infection. Interferon alerts all nearby cells that a viral infection is under way, triggering the production of proteins that block viral replication. Interferon also causes cells to stop producing proteins that viruses need to replicate and thrive. Doctors suspect interferon also protects cells against viruses through other means; research into the way it works is on-going.

c. formulation if interferon alpha

1. Interferon alfa-2B--------C16H17Cl3I2N3NaO5S

• 30-35 million Units SC/IM per wk, either as 5 million Units qDay or 10 millon Units 3 times/wk for 16 wk
• If severe adverse reactions develop reduce dose by 50% or temporarily withhold until adverse reaction abate
• If intolerance persists discontinue permanently.

5. Treatment for chronic hepatitis B infection:-

1. Antiviral medications. Several antiviral medications — including entecavir (Baraclude), tenofovir (Viread), lamivudine (Epivir), adefovir (Hepsera) and telbivudine (Tyzeka) — can help fight the virus and slow its ability to damage your liver.
2. Interferon injections. Interferon alfa-2b (Intron A) is a man-made version of a substance produced by the body to fight infection. It's used mainly for young people with hepatitis B who wish to avoid long-term treatment or women who might want to get pregnant within a few years, after completing a finite course of therapy.
3. Liver transplant. If your liver has been severely damaged, a liver transplant may be an option. During a liver transplant, the surgeon removes your damaged liver and replaces it with a healthy liver.
4. Immune modulator Drugs – These are interferon-type drugs that boost the immune system to help get rid of the hepatitis B virus. They are given as a shot (similar to how insulin is given to people with diabetes) over 6 months to 1 year.

6. Monitoring:

• You will be checked regularly by your healthcare professional while you are taking interferon alfa, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.
• Your thyroid gland may also be affected by this medication. Your healthcare professional may order a blood test periodically to assess your thyroid function.
• An eye test should be done if any changes in vision occur.
• If you have any heart conditions, additional test may be done to test your heart function.

7. additional advice  

1. Vaccinations -- Everyone with chronic hepatitis B should be vaccinated against hepatitis A unless they are known to be immune.
2. Liver cancer screening
3. Diet---The best advice is to eat a normal healthy and balanced diet and to maintain a normal weight.
4. Alcohol -- Alcohol should be avoided since it can worsen liver damage. All types of alcoholic beverages can be harmful to the liver. People with hepatitis B can develop liver complications even with small amounts of alcohol.
5. Smoking -- Smoking is harmful for your health and should be avoided. In addition, smoking has been shown in some studies to increase the risk of liver cancer in people with hepatitis B.
6. Exercise-- Exercise is good for overall health and is encouraged, but it has no effect on the hepatitis B virus. Exercise is not harmful to the liver, even in people with chronic hepatitis or cirrhosis.
7. Prescription and nonprescription drugs -- Many medications are broken down by the liver. Thus, it is always best to check with a healthcare provider or pharmacist before starting a new medication. As a general rule, unless the liver is already scarred, most drugs are safe for people with hepatitis B.
8. Herbal medications--No herbal treatment has been proven to improve outcomes in patients with hepatitis B, and some can cause serious liver toxicity. Herbal treatments are not recommended for anyone with hepatitis B.