Can a baby get hep B from breast milk?

Can a baby get hep B from breast milk?








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Can a baby get hep B from breast milk?/Hepatitis B Virus (HBV) infection is a major global health problem leading to severe liver diseases such as cirrhosis and hepatocellular carcinoma (HCC). HBV is a circular, partly double-stranded DNA virus with various serological markers: hepatitis B surface antigen (HBsAg) and anti-HBs, anti-HBc IgM and IgG, and hepatitis B e antigen (HBeAg) and anti-HBe. It is transmitted by the sexual, parenteral and vertical routes. One significant method to diminish the burden of this disease is the timely diagnosis of acute, chronic and occult cases of HBV. The first step of HBV diagnosis is achieved by using serological markers for detecting antigens and antibodies.

Hepatitis B is a liver infection caused by the hepatitis B virus (HBV). Hepatitis B is transmitted when blood, semen, or another body fluid from a person infected with the hepatitis B virus enters the body of someone who is not infected. This can happen through sexual contact; sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth. For some people, hepatitis B is an acute, or short-term, illness but for others, it can become a long-term, chronic infection. The risk for chronic infection is related to age at infection approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. Chronic hepatitis B can lead to serious health issues, like cirrhosis or liver cancer. The best way to prevent hepatitis B is by getting vaccinated.

Mechanisms of Hepatitis B

Hepatitis B virus primarily interferes with the functions of the liver by replicating in hepatocytes. A functional receptor is NTCP.[rx] There is evidence that the receptor in the closely related duck hepatitis B virus is carboxypeptidase D.[rx][rx] The virions bind to the host cell via the preS domain of the viral surface antigen and are subsequently internalized by endocytosis. HBV-preS-specific receptors are expressed primarily on hepatocytes; however, viral DNA and proteins have also been detected in extrahepatic sites, suggesting that cellular receptors for HBV may also exist on extrahepatic cells.[rx] During HBV infection, the host immune response causes both hepatocellular damage and viral clearance. Although the innate immune response does not play a significant role in these processes, the adaptive immune response, in particular, virus-specific cytotoxic T lymphocytes(CTLs), contributes to most of the liver injury associated with HBV infection. CTLs eliminate HBV infection by killing infected cells and producing antiviral cytokines, which are then used to purge HBV from viable hepatocytes.[rx] Although liver damage is initiated and mediated by the CTLs, antigen-nonspecific inflammatory cells can worsen CTL-induced immunopathology, and platelets activated at the site of infection may facilitate the accumulation of CTLs in the liver.[rx]

Types of Hepatitis B

Hepatitis B vaccine can prevent hepatitis B.  Hepatitis B is a liver disease that can cause mild illness lasting a few weeks, or it can lead to a serious, lifelong illness.

  • Acute hepatitis B infection is a short-term illness that can lead to fever, fatigue, loss of appetite, nausea, vomiting, jaundice (yellow skin or eyes, dark urine, clay-colored bowel movements), and pain in the muscles, joints, and stomach.
  • Chronic hepatitis B infection is a long-term illness that occurs when the hepatitis B virus remains in a person’s body. Most people who go on to develop chronic hepatitis B do not have symptoms, but it is still very serious and can lead to liver damage (cirrhosis), liver cancer, and death. Chronically-infected people can spread hepatitis B virus to others, even if they do not feel or look sick themselves.

Transmitted of Hepatitis B

Hepatitis B is spread when blood, semen, or other body fluid infected with the hepatitis B virus enters the body of a person who is not infected. People can become infected through:

  • Birth (if a mother has hepatitis B, her baby can become infected)
  • Sharing items such as razors or toothbrushes with an infected person
  • Contact with the blood or open sores of an infected person
  • Sex with an infected partner
  • Sharing needles, syringes, or other drug-injection equipment
  • Exposure to blood from needlesticks or other sharp instruments

Most people who are vaccinated with hepatitis B vaccine are immune for life

Who Is At Risk For HBV Infection?

The following populations are at increased risk of becoming infected with HBV

  • Infants born to infected mothers
  • Sex partners of infected persons
  • Men who have sex with men
  • Injection drug users
  • Household contacts or sexual partners of known persons with chronic HBV infection
  • Health care and public safety workers at risk for occupational exposure to blood or blood-contaminated body fluids, and
  • Hemodialysis patients

Who should be screened for HBV?

Screening should include testing to three HBV screening zero markers (HBsAg, antibody to HBsAg [anti-HBs], and antibody to hepatitis B core antigen [anti-HBc]) so that persons can be classified into the appropriate hepatitis B category and properly recommended to receive vaccination, counseling, and linkage to care and treatment[rx].

Persons who should be screened for HBV [rxrx]:

  • Persons born in countries with 2% or higher HBV prevalence
  • Men who have sex with men
  • Persons who inject drugs
  • HIV-positive persons
  • Household and sexual contacts of HBV-infected persons
  • Persons requiring immunosuppressive therapy
  • Persons with end-stage renal disease (including hemodialysis patients)
  • Blood and tissue donors
  • Persons with elevated alanine aminotransferase levels (>19 IU/L for women and >30 IU/L for men)
  • Pregnant women (HBsAg only is recommended)
  • Infants born to HBV-infected mothers (HBsAg and anti-HBs are only recommended)

Causes of Hepatitis B

  • TransmissionTransmission of hepatitis B virus results from exposure to infectious blood or body fluids containing blood. It is 50 to 100 times more infectious than the human immunodeficiency virus (HIV).[rx] Possible forms of transmission include sexual contact,[rx] blood transfusions and transfusion with other human blood products,[rx] re-use of contaminated needles and syringes,[rx] and vertical transmission from mother to child (MTCT) during childbirth. Without intervention, a mother who is positive for HBsAg has a 20% risk of passing the infection to her offspring at the time of birth.
  • Sexual contact – You may get hepatitis B if you have unprotected sex with someone who is infected. The virus can pass to you if the person’s blood, saliva, semen or vaginal secretions enter your body.
  • Sharing of needles – HBV easily spreads through needles and syringes contaminated with infected blood. Sharing IV drug paraphernalia puts you at high risk of hepatitis B.
  • Accidental needle sticks – Hepatitis B is a concern for health care workers and anyone else who comes in contact with human blood.
  • Mother to child – Pregnant women infected with HBV can pass the virus to their babies during childbirth. However, the newborn can be vaccinated to avoid getting infected in almost all cases. Talk to your doctor about being tested for hepatitis B if you are pregnant or want to become pregnant.

Symptoms of Hepatitis B

Newly acquired (acute) HBV infections only cause symptoms some of the time. The presence of signs and symptoms varies by age. Most children under age 5 years and newly infected immunosuppressed adults are generally asymptomatic, whereas 30%–50% of persons aged ≥5 years have signs and symptoms [rx].

Acute HBV infections can include

  • Abdominal pain
  • Acute viral hepatitis
  • An illness that begins with general ill-health
  • Loss of appetite
  • Nausea, vomiting
  • Body aches
  • Mild fever, and dark urine, and then progress to the development of jaundice. 

Chronic infection

  • Chronic inflammation of the liver (chronic hepatitis),
  • Leading to cirrhosis over a period of several years.
  • Hepatocellular carcinoma (HCC; liver cancer).
  • Chronic carriers are encouraged to avoid consuming alcohol as it increases their risk for cirrhosis and liver cancer.
  • Hepatitis B virus has been linked to the development of membranous glomerulonephritis (MGN).[rx]
  • Serum-sickness–like syndrome, acute necrotizing vasculitis (polyarteritis nodosa),
  • Membranous glomerulonephritis,
  • Papular acrodermatitis of childhood (Gianotti–Crosti syndrome).[rx][rx]
  • The serum-sickness–like syndrome occurs in the setting of acute hepatitis B, often preceding the onset of jaundice.
  • The clinical features are fever, skin rash, and polyarteritis.

Overall Symptoms

Some acute HBV infections will resolve on their own, but some will develop into a chronic infection. Most persons with chronic HBV infection are asymptomatic and have no evidence of liver disease. However, some persons may develop chronic hepatitis (elevation of AST/ALT), cirrhosis, or hepatocellular carcinoma (a type of liver cancer).

Diagnosis of Hepatitis B

Laboratory diagnosis of hepatitis B infection focuses on the detection of the hepatitis B surface antigen HBsAg. WHO recommends that all blood donations be tested for hepatitis B to ensure blood safety and avoid accidental transmission to people who receive blood products.

  • Acute HBV infection –  is characterized by the presence of HBsAg and immunoglobulin M (IgM) antibody to the core antigen, HBcAg. During the initial phase of infection, patients are also seropositive for hepatitis B e antigen (HBeAg). HBeAg is usually a marker of high levels of replication of the virus. The presence of HBeAg indicates that the blood and body fluids of the infected individual are highly infectious.
  • Chronic infection – is characterized by the persistence of HBsAg for at least 6 months (with or without concurrent HBeAg). Persistence of HBsAg is the principal marker of risk for developing chronic liver disease and liver cancer (hepatocellular carcinoma) later in life.
  • Blood tests – Blood tests can detect signs of the hepatitis B virus in your body and tell your doctor whether it’s acute or chronic. A simple blood test can also determine if you’re immune to the condition.
  • Liver ultrasound – A special ultrasound called transient elastography can show the amount of liver damage.
  • Liver biopsy – Your doctor might remove a small sample of your liver for testing (liver biopsy) to check for liver damage. During this test, your doctor inserts a thin needle through your skin and into your liver and removes a tissue sample for laboratory analysis.

Hepatitis B Serology

  • Hepatitis B surface antigen (HBsAg) – The presence of HBsAg, a protein on the surface of HBV, indicates that the person is infectious. It can be detected in high levels in serum during acute or chronic HBV infection. The body normally produces antibodies to HBsAg as part of the normal immune response to infection. HBsAg is the antigen used to make the hepatitis B vaccine.
  • Hepatitis B surface antibody (anti-HBs) – The presence of anti-HBs is generally interpreted as indicating recovery and immunity from HBV infection. Anti-HBs also develops in a person who has been successfully vaccinated against hepatitis B.
  • Total hepatitis B core antibody (anti-HBc) – Appears at the onset of symptoms in acute hepatitis B and persists for life. The presence of anti-HBc indicates previous or ongoing infection with HBV in an undefined time frame.
  • IgM antibody to hepatitis B core antigen (IgM anti-HBc) – Positivity indicates recent infection with HBV (≤6 months). Its presence indicates acute infection.
  • Hepatitis B e antigen (HBeAg) – The presence indicates that the virus is replicating and the infected person has high levels of HBV. HBeAg is a secreted product of the nucleocapsid gene of HBV that is found in serum during acute and chronic hepatitis B.
  • Hepatitis B e antibody (HBeAb or anti-HBe) – Spontaneous conversion from e antigen to e antibody (a change known as seroconversion) is a predictor of long-term clearance of HBV in patients undergoing antiviral therapy and indicates lower levels of HBV. HBeAg is produced by the immune system temporarily during acute HBV infection or consistently during or after a burst in viral replication.
  • HBV DNA – HBV DNA concentration correlates with levels of HBV virus particles. HBV DNA is measured as IU/mL or copies/ml by the polymerase chain reaction assay. HBV viral DNA can be detected and quantified in serum. There are several commercial assays that can detect and quantify HBV DNA, some to limits as low as 10 IU/ml.

The following table provides interpretations for different combinations and results of hepatitis B serologic markers.

Antibody and Antigen Biomarkers for Hepatitis B Infection [rx]

Clinical state HBsAg Total Anti-HBs Total anti-HBc Action
Table. Antibody and Antigen Biomarkers for Hepatitis B Infection 
Chronic infection Positive Negative Positive Link to hepatitis B-directed care
Acute Positive Negative Positive
(IgM anti-HBc)
Link to hepatitis B-directed care
Resolved infection Negative Positive Positive Counseling, reassurance
Immune (immunization) Negative Positive Negative Reassurance
Susceptible
(never infected and no evidence of immunization)
Negative Negative Negative Vaccinate
*Isolated core antibody Negative Negative Positive Depends on the situation

False-positive: Repeat testing required

  • Past infection – No action needed
  • Occult HBV infection – Needs to be known if the patient ever becomes immunosuppressed or given chemotherapy or treated with antiviral therapy for hepatitis C virus infection. Consider monitoring HBV DNA.

Passive transfer to an infant born to HBsAg-positive mother No specific action needed.

  • Hepatitis B surface antigen (HBsAg) – A protein on the surface of HBV; it can be detected in high levels in serum during acute or chronic HBV infection. The presence of HBsAg indicates that the person is infectious. The body normally produces antibodies to HBsAg as part of the normal immune response to infection. HBsAg is the antigen used to make the hepatitis B vaccine.
  • Hepatitis B surface antibody (anti-HBs) – The presence of anti-HBs is generally interpreted as indicating recovery and immunity from HBV infection. Anti-HBs also develops in a person who has been successfully vaccinated against hepatitis B.
  • Total hepatitis B core antibody (anti-HBc) – Appears at the onset of symptoms in acute hepatitis B and persists for life. The presence of anti-HBc indicates previous or ongoing infection with HBV in an undefined time frame.
  • IgM antibody to hepatitis B core antigen (IgM anti-HBc) – Positivity indicates recent infection with HBV (≤6 months). Its presence indicates acute infection.

Hepatitis B Virus Serological and Virological Markers

HBsAg HBV infection, both acute and chronic
HBeAg High-level HBV replication and infectivity; marker for treatment response
HBV DNA Level of HBV replication; primary virologic marker for treatment response
Anti-HBc (IgM) Acute HBV infection; could be seen in flare of chronic hepatitis B
Anti-HBc (IgG) Recovered or chronic HBV infection
Anti-HBs Recovered HBV infection or marker of HBV vaccination; immunity to HBV infection (titer can be measured to assess vaccine efficacy)
Anti-HBe Low-level HBV replication and infectivity; marker for treatment response
Anti-HBc (IgG) and anti-HBs Past HBV infection; could lose anti-HBs
Anti-HBc (IgG) and HBsAg Chronic HBV infection
Anti-HBc (IgG) and/or anti-HBs and HBV DNA (PCR) Latent or occult HBV infection
Methods of HBV genotyping
Methods Advantages Disadvantages References
RFLP Easily done, low cost, simple, rapid Low sensitivity for typing samples with low HBV [,
Reverse hybridization High sensitivity, automated systems Relatively high cost [,
Genotype specific PCR High sensitivity, automated systems, easy to perform, suitable for detecting mixed genotype infections High cost [
Sequence analysis A gold standard method for genotyping, identification of patients infected with recombinant genotypes Time-consuming, technically demanded [

HBV, hepatitis B virus; RFLP, restriction fragment length polymorphism; PCR, polymerase chain reaction.

Treatment of Hepatitis B

In this guideline we cover the following:

  • Information needs of people with chronic hepatitis B and their carers
  • Where children, young people, and adults with chronic hepatitis B should be assessed
  • Assessment of liver disease, including the use of non-invasive tests and genotype testing
  • Criteria for offering antiviral treatment
  • The efficacy, safety, and cost-effectiveness of currently available treatments
  • Selection of first-line therapy
  • Management of treatment failure or drug resistance
  • Whether there is a role for combination therapy
  • When it is possible to stop treatment
  • Managing the care of pregnant and breastfeeding women and prevention of vertical transmission
  • Prophylactic treatment during immunosuppressive therapy
  • Monitoring for treatment response, the severity of fibrosis and development of HCC.
If the infection is active for longer than 6 months, he’ll tell you that you have chronic active hepatitis B. He may prescribe some of these medications to treat it:

  • Get plenty of rest
  • Take over-the-counter painkillers, such as paracetamol or ibuprofen, for tummy pain
  • Maintain a cool, well-ventilated environment, wear loose clothing, and avoid hot baths or showers if itching is a problem
  • Take medication  such as metoclopramide, to stop you feeling sick, and chlorphenamine to reduce itching – your doctor can give you a prescription for these if necessary
  • 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. These drugs are taken by mouth. Talk to your doctor about which medication might be right for you.
  • Entecavir ( Baraclude ) – This is the newest drug for hepatitis B. You can take it as a liquid or tablet.
  • Tenofovir (Viread) – This drug comes as a powder or tablet. If you take it, your doctor will check often to make sure it doesn’t hurt your kidneys.
  • Lamivudine (3tc, , Epivir A/F, Epivir HBV, Heptovir) – It comes as a liquid or tablet you take once a day. Most people don’t have a problem with it. But if you take it for a long time, the virus might stop responding to the drug.
  • Adefovir dipivoxil ( Hepsera ) – This drug, which you take as a tablet, works well for people who don’t respond to lamivudine. High doses can cause kidney problems.
  • Interferon alfa ( Intron A, Roferon A, Sylatron) – This medicine boosts your immune system. You take it as a shot for at least 6 months. It doesn’t cure the disease. It treats liver inflammation. Long-acting interferon, peginterferon alfa2a (Pegasys, Pegasys Proclick) can also help. This drug can make you feel bad all over or depressed, and it can and zap your appetite. It also lowers your white blood cell count, which makes it harder to fight off infection.
  • 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. Interferon should not be used during pregnancy. Side effects may include nausea, vomiting, difficulty breathing and depression.

Indications for treatment and recommended strategy for chronic hepatitis B

AASLD 2009 EASL 2012 APASL 2012
HBeAg positive hepatitis Indications for treatment HBV DNA > 20000 IU/mL and ALT > 2 × ULN HBV DNA > 2000 IU/mL and ALT > ULN HBV DNA > 20000 IU/mL and ALT > 2 × ULN
Biopsy recommended HBV DNA >20000 IU/mL and ALT 1-2 × UNL especially if age > 40 yr or family history of HCC HBV DNA > 2000 IU/mL and Age > 30 yr or family history of HCC HBV DNA > 20000 IU/mL or high normal or minimally raised ALT and age > 40 yr
Preferred drugs for naïve patients PEG-IFN, ETV, TDF PEG-IFN, ETV, TDF IFN-based therapy, ETV, TDF
HBeAg negative hepatitis Indications for treatment HBV DNA >20000 IU/mL2 and ALT > 2 × ULN HBV DNA > 2000 IU/mL and ALT > ULN HBV DNA > 2000 IU/mL and ALT > 2 × ULN
Biopsy recommended HBV DNA >2000 IU/mL and ALT 1- > 2 × UNL Unmentioned HBV DNA > 2000 IU/mL or high normal or minimally raised ALT and age > 40 yr
Preferred drugs for naïve patients PEG-IFN, ETV, TDF PEG-IFN, ETV, TDF IFN-based therapy, ETV, TDF
Liver cirrhosis Indication for treatment Compensated: HBV DNA >2000 IU/mL; consider treating HBV < 2000 IU/mL if ALT > UNL Decompensated: any detectable HBV DNA Any detectable HBV DNA Compensated: HBV DNA > 2000 IU/mL Decompensated: any detectable HBV DNA
Preferred drugs for naïve patients Combination of LAM (or LDT) and ADV, ETV, TDF Compensated: PEG-IFN, ETV, TDF Decompensated: ETV, TDF ETV, TDF (consider also IFN-based therapy if compensated LC and ALT < 5 × UNL)
Consider treatment if moderate to severe inflammation or significant fibrosis is shown on liver biopsy; noninvasive methods may be useful in EASL and APASL guidelines; Treatment may be considered in patients with HBV DNA 2000-20000 IU/mL, particularly if they are older or have cirrhosis.AASLD: The American Association for the Study of the Liver Diseases; EASL: European Association for the Study of the Liver; APASL: The Asian Pacific Association for the Study of the Liver; ULN: The upper limit of normal; PEG-IFN: Pegylated interferon; ETV: Entecavir; TDF: Tenofovir; IFN: Interferon; LAM: Lamivudine; LDT: Telbivudine; ADV: Adefovir.
  • Pegylated interferon – The most important advantage of PEG-IFN use in clinical practice is finite duration of treatment. In addition, the antiviral response is more durable with higher HBeAg seroconversion and HBsAg seroconversion after treatment compared with NAs. However, frequent adverse events, low degree of compliance due to injection-related problems[]
  • LAM – Although LAM is the first approved oral antiviral agent against HBV, the emergence of drug-resistant tyrosine-methionine-aspartate-aspartate (YMDD) mutants has been a major hindrance to long-term LAM treatment. The frequency of genotypic resistance was reported to be as high as 60%-70% after 5 years of treatment[,]. Therefore, it is no longer recommended as the first-line treatment for CHB patients in the current international guidelines, but it may be recommended in combination therapies with ADV or TDF for liver cirrhosis[].
  • ADV – ADV is the acyclic analog of dAMP with therapeutic efficacy against both the wild-type and YMDD mutant HBV. Two previous major phases III clinical studies showed that ADV demonstrated significant virological and biochemical responses, and histological improvement in HBeAg-positive and -negative naïve CHB patients[,]. ADV has also demonstrated virological improvement in patients with LAM-resistant HBV, regardless if used alone or in combination with ongoing LAM therapy[,]. Although ADV has been widely accepted as advantageous over LAM in terms of the development of genotypic resistance, it is not recommended as the first-line drug for HBeAg-positive and -negative CHB patients in the current international guidelines as it is less effective than other NAs such as ETV and TDF in antiviral activity[], and possesses a significant risk of nephrotoxicity[].
  • Entecavir – ETV is a deoxyguanosine nucleoside analog that has highly potent antiviral activity and a high genetic barrier to resistance against HBV. In long-term follow-up studies of ETV for the treatment of chronic HBV infection for up to 5 years, it was very safe and well-tolerated and showed high rates of HBV-DNA suppression, ALT normalization and serological responses in both HBeAg-positive and -negative CHB patients[,].
  • LdT – LdT is the L-nucleoside analog of L-deoxythymidine and displays potent antiviral activity comparable to that of ETV. HBV-DNA was undetectable (< 300 copies/mL) in 60% of HBeAg-positive CHB patients and 88% of HBeAg-negative CHB patients treated with LdT[]. In addition, ALT normalization was found in 77% and 74%, respectively[]. HBeAg seroconversion in HBeAg-positive CHB patients was observed in 23% and 30% at year 2 in two studies[,].
  • Clevudine – Clevudine is a pyrimidine analogue with potent and sustained antiviral activity against HBV. Previous clinical studies conducted in Korea have demonstrated that clevudine showed potent antiviral activity during therapy and induced a sustained post-treatment antiviral effect for 6 mo after a 12- and 24-wk treatment period[,].
  • TDF – TDF is an acyclic nucleotide inhibitor and has been proved to be a highly powerful antiviral agent against HBV without resistance to TDF during the treatment period[,]. In a three-year follow-up study, levels of HBV-DNA below 400 copies/mL at week 144 was observed in 72% of HBeAg-positive and in 87% of HBeAg-negative patients treated with TDF monotherapy[].

Recommended treatment for drug resistance

Resistance to AASLD 2009 EASL 2012 APASL 2012
LAM Add ADV or TDF Switch to Truvada1 Switch to TDF (add ADV if TDF is not available) Add ADV Switch to TDF Switch to IFN-based therapy
LDT Add ADV or TDF Switch to Truvada1 Switch to or add TDF (add ADV if TDF is not available) Add ADV Switch to TDF
ADV Add LAM Switch to Truvada1Switch to or add ETV Switch to ETV or TDF Switch to TDF and add a nucleoside analogue if the patient has been treated with LAM Add LAM, LDT or ETV Switch to TDF Switch to ETV plus TDF, if the patient has been treated with LAM or LDT
ETV Switch to TDF or Truvada1 Switch to or add TDF (add ADV if TDF is not available) Add TDF or ADV
TDF Unmentioned Add ETV, LDT, LAM or emtricitabine Switch to ETV if the patient has not been treated with LAM in the past Unmentioned
MDR Unmentioned Combination of a nucleoside and a nucleotide Unmentioned
Truvada is a combination pill containing emtricitabine 200 mg and tenofovir 300 mg. LAM: Lamivudine; LDT: Telbivudine; ADV: Adefovir; ETV: Entecavir; TDF:Tenofovir; MDR: Multidrug resistance; IFN: Interferon.
  • Lamivudine resistance – Although LAM is safe and tolerated in compensated and decompensated liver diseases due to HBV, it has limited clinical use in CHB patients due to a high rate of drug resistance. Previously, ADV alone or in combination with ongoing LAM therapy was used for the treatment of rtM204V/I mutant by LAM[]. However, the rate of ADV resistance after direct switching from LAM to ADV in LAM-resistant patients was as high as 18% at year 1 and 65.6% at year 5, respectively[,].
  • Adefovir resistance – ADV resistance is caused by rtN236T mutation in the D domain and rtA181T/V in the B domain of the HBV polymerase gene. A long-term follow-up study of ADV monotherapy for 48 wk in HBeAg-negative CHB showed ADV resistance in 0% at year 1 and 29% of patients at year 5[]
  • 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. Most transplanted livers come from deceased donors, though a small number come from living donors who donate a portion of their livers.

FDA Approved Treatment of Hepatitis B

Approved Treatments for Hepatitis B

Brand Name Generic
Names
Manufacturer Name Indication
Baraclude entecavir Bristol-Myers Squibb chronic hepatitis B virus infection with evidence of active viral replication
Epivir HBV lamivudine GlaxoSmithKline chronic hepatitis B associated with hepatitis B viral replication and active liver inflammation
Hepsera adefovir dipivoxil Gilead Sciences chronic hepatitis B in patients 12 years of age
Intron A interferon-alpha-2b Schering chronic hepatitis B in patients 1 year of age or older with compensated liver disease
Pegasys pegylated interferon Roche treatment of adult patients with HBeAg positive and HBeAg negative chronic hepatitis B who have compensated liver disease and evidence of viral replication and liver inflammation
Tyzeka telbivudine Novartis chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Vemlidy tenofovir alafenamide Gilead Sciences indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease
Viread tenofovir Gilead Sciences chronic hepatitis B in adults.

For additional information on approved treatments for Hepatitis, you can search drugs@fda[rx] orDailyMed[rx].

Approved Treatments for Hepatitis C

Brand Name Generic Names Manufacturer Name Indication
CoPegus ribavirin Roche use in combination with Pegasys or with Roferon for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon-alpha
Daklinza daclatasvir Bristol-Myers Squibb Company an NS5A replication complex inhibitor is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving this regimen. The recommended dosage of DAKLINZA is 60 mg, taken orally, once daily in combination with sofosbuvir for 12 weeks. DAKLINZA may be taken with or without food. The optimal duration of DAKLINZA and sofosbuvir for patients with cirrhosis has not been established.
Epclusa sofosbuvir, velpatasvir Gilead a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection -without cirrhosis or with compensated cirrhosis or with decompensated cirrhosis for use in combination with ribavirin
Harvoni ledipasvir/sofosbuvir Gilead a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.
Incivek telaprevir Vertex Pharmaceuticals in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers
Infergen interferon aphacon-1 Three Rivers Pharma treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or HCV RNA
Intron A interferon alpha-2b Schering treatment of chronic hepatitis C in patients 18 years of age or older with compensated liver disease who have a history of blood or blood-product exposure and/or are HCV antibody positive
Mavyret glecaprevir and pibrentasvir AbbieVie
  • is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 6 infections without cirrhosis
  • with compensated cirrhosis (Child-Pugh A).
  • indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both
Olysio simeprevir Janssen Pharmaceuticals for the treatment of chronic hepatitis C (CHC) genotype 1 infection as a component of a combination antiviral treatment regimen
Pegasys pegylated interferon Roche treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon-alpha
Pegintron pegylated interferon-alpha-2b Schering in combination with rebetol, is indicated for the treatment of chronic hepatitis C in patients 3 years of age and older with compensated liver disease use alone for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with interferon-alpha and who are at least 18 years of age and intolerant to ribavirin
Rebetol ribavirin Schering use in combination with Pegintron for treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon-alpha and are at least 18 years of age
Roferon interferon-alpha-2a Roche treatment of chronic hepatitis C in patients 18 years of age or older
Sovaldi sofosbuvir Gilead Sciences for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen
Technivie ombitasvir, paritaprevir and ritonavir AbbVie Inc. a fixed-dose combination containing ombitasvir, a hepatitis C virus NS5A inhibitor; paritaprevir, a hepatitis C virus NS3/4A protease inhibitor; and ritonavir, a CYP3A inhibitor. The product is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis.
Victrelis boceprevir Merck & Co. treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Viekira Pak ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets AbbVie Inc. use with or without ribavirin for the treatment of patients with genotype 1 chronic hepatitis C virus (HCV) infection including those with compensated cirrhosis
Vosevi treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir, or other drugs for HCV that inhibit a protein called NS5A
Zepatier elbasvir, grazoprevir Merck Sharp Dohme a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated with or without ribavirin for treatment of chronic HCV genotypes 1 or 4 infections in adults

Hepatitis B Vaccination

Who should be vaccinated against hepatitis B?

The Advisory Committee on Immunization Practices (ACIP) recommends that the following people receive hepatitis B vaccination:

  • All infants
  • Unvaccinated children aged <19 years
  • People at risk for infection by sexual exposure
    • Sex partners of hepatitis B surface antigen (HBsAg)–positive persons
    • Sexually active people who are not in a long-term, mutually monogamous relationship (e.g., persons with more than one sex partner during the previous 6 months)
    • People seeking evaluation or treatment for a sexually transmitted infection
    • Men who have sex with men
  • People at risk for infection by percutaneous or mucosal exposure to blood
    • Current or recent injection-drug users
    • Household contacts of people who are HBsAg-positive
    • Residents and staff of facilities for developmentally disabled people
    • Health care and public safety personnel with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids
    • Hemodialysis patients and predialysis, peritoneal dialysis, and home dialysis patients
    • People with diabetes aged 19–59 years; persons with diabetes aged ≥60 years at the discretion of the treating clinician
  • International travelers to countries with high or intermediate levels of endemic hepatitis B virus (HBV) infection (HBsAg prevalence of ≥2%)
  • People with hepatitis C virus infection
  • People with chronic liver disease (including, but not limited to, persons with cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the upper limit of normal)
  • People with HIV infection
  • People who are incarcerated
  • All other people seeking protection from HBV infection


Is hepatitis B vaccination recommended in certain settings?

Yes. In certain health care, evaluation, or treatment settings, a high proportion of clients have known risk factors for HBV infection. The Advisory Committee on Immunization Practices recommends universal vaccination of adults who receive care in those settings, including:

  • Sexually transmitted disease treatment facilities
  • HIV testing and treatment facilities
  • Facilities providing drug-abuse treatment and prevention services
  • Health care settings targeting services to injection drug users
  • Correctional facilities
  • Health care settings targeting services to men who have sex with men
  • Chronic hemodialysis facilities and end-stage renal disease programs
  • Institutions and nonresidential day care facilities for developmentally disabled persons

What are the hepatitis B vaccines licensed for use in the United States?

Three single-antigen vaccines and three combination vaccines are currently licensed in the United States.

Single-antigen hepatitis B vaccines

  • ENGERIX-B
  • RECOMBIVAX HB
  • HEPLISAV-B™

Combination vaccines

  • PEDIARIX – Combined hepatitis B, diphtheria, tetanus, acellular pertussis (DTaP), and inactivated poliovirus (IPV) vaccine. It cannot be administered before age 6 weeks or after age 7 years.
  • TWINRIX – Combined Hepatitis A and hepatitis B vaccine. Recommended for persons aged ≥18 years who are at increased risk for both Hepatitis A virus and HBV infections.

Who Get The Hepatitis B vaccine

Hepatitis B vaccine is usually given as 2, 3, or 4 shots.

  • Infants – should get their first dose of the hepatitis B vaccine at birth and will usually complete the series at 6 months of age (sometimes it will take longer than 6 months to complete the series).
  • Children and adolescents who are – younger than 19 years of age who have not yet gotten the vaccine should also be vaccinated.

Hepatitis B vaccine is also recommended for certain unvaccinated adults

  • People whose sex partners have hepatitis B
  • Sexually active persons who are not in a long-term monogamous relationship
  • Persons seeking evaluation or treatment for a sexually transmitted disease
  • Men who have sexual contact with other men
  • People who share needles, syringes, or other drug-injection equipment
  • People who have household contact with someone infected with the hepatitis B virus
  • Health care and public safety workers at risk for exposure to blood or body fluids
  • Residents and staff of facilities for developmentally disabled persons
  • Persons in correctional facilities
  • Victims of sexual assault or abuse
  • Travelers to regions with increased rates of hepatitis B
  • People with chronic liver disease, kidney disease, HIV infection, infection with hepatitis C, or diabetes
  • Anyone who wants to be protected from hepatitis B

Hepatitis B vaccine may be given at the same time as other vaccines.

Tell your vaccine provider if the person getting the vaccine

  • Has had an allergic reaction after a previous dose of hepatitis B vaccine, or has any severe, life-threatening allergies.
  • In some cases, your health care provider may decide to postpone hepatitis B vaccination to a future visit. People with minor illnesses, such as a cold, maybe vaccinated. People who are moderately or severely ill should usually wait until they recover before getting the hepatitis B vaccine. Risks of a vaccine reaction Soreness where the shot is given or fever can happen after the hepatitis B vaccine.
  • People sometimes faint after medical procedures, including vaccination. Tell your provider if you feel dizzy or have vision changes or ringing in the ears. As with any medicine, there is a very remote chance of a vaccine causing a severe allergic reaction, another serious injury, or death.

Prevention of Hepatitis B

  • Babies born to hepatitis B-infected mothers
  • Close family and sexual partners of someone with hepatitis B
  • People traveling to a part of the world where hepatitis B is widespread, such as sub-Saharan Africa, east and southeast Asia, and the Pacific Islands
  • Families adopting or fostering children from high-risk countries
  • People who inject drugs or have a sexual partner who injects drugs
  • People who change their sexual partner frequently
  • Men who have sex with men
  • Male and female sex workers
  • People who work somewhere that places them at risk of contact with blood or body fluids, such as nurses, prison staff, doctors, dentists and laboratory staff
  • People with chronic liver disease
  • people with chronic kidney disease
  • Prisoners
  • People who receive regular blood or blood products, and their carers

The hepatitis B vaccine is the mainstay of hepatitis B prevention. WHO recommends that all infants receive the hepatitis B vaccine as soon as possible after birth, preferably within 24 hours. Routine infant immunization against hepatitis B has increased globally with an estimated coverage (third dose) of 84% in 2017. The low prevalence of chronic HBV infection in children under 5 years of age, estimated at 1.3% in 2015, can be attributed to the widespread use of hepatitis B vaccine. In most cases, 1 of the following 2 options is considered appropriate:

  • a 3-dose schedule of hepatitis B vaccine, with the first dose (monovalent) given at birth and the second and third doses (monovalent or combined vaccine) given at the same time as the first and third doses of diphtheria, pertussis (whooping cough), and tetanus – (DTP vaccine); or
  • a 4-dose schedule, where a monovalent birth dose is followed by 3 monovalent or combined vaccine doses, usually given with other routine infant vaccines.

The complete vaccine series induces protective antibody levels in more than 95% of infants, children and young adults. Protection lasts at least 20 years and is probably lifelong. Thus, the WHO does not recommend booster vaccinations for persons who have completed the 3 dose vaccination schedule.

All children and adolescents younger than 18 years and not previously vaccinated should receive the vaccine if they live in countries where there is low or intermediate endemicity. In those settings, it is possible that more people in high-risk groups may acquire the infection and they should also be vaccinated. This includes:

  • people who frequently require blood or blood products, dialysis patients and recipients of solid organ transplantations;
  • people in prisons;
  • people who inject drugs;
  • household and sexual contacts of people with chronic HBV infection;
  • people with multiple sexual partners;
  • healthcare workers and others who may be exposed to blood and blood products through their work; and
  • travelers who have not completed their HBV series, who should be offered the vaccine before leaving for endemic areas.

The vaccine has an excellent record of safety and effectiveness. Since 1982, over 1 billion doses of hepatitis B vaccine have been used worldwide. In many countries where 8–15% of children used to become chronically infected with the hepatitis B virus, vaccination has reduced the rate of chronic infection to less than 1% among immunized children.

In addition to infant vaccination, the implementation of blood safety strategies, including quality-assured screening of all donated blood and blood components used for transfusion, can prevent transmission of HBV. Worldwide, in 2013, 97% of blood donations were screened and quality assured, but gaps persist. Safe injection practices, eliminating unnecessary and unsafe injections, can be effective strategies to protect against HBV transmission. Unsafe injections decreased from 39% in 2000 to 5% in 2010 worldwide. Furthermore, safer sex practices, including minimizing the number of partners and using barrier protective measures (condoms), also protect against transmission.

WHO Response For Hepatitis B

In March 2015, WHO launched its first “Guidelines for the prevention, care and treatment of persons living with chronic hepatitis B infection”. The recommendations include:

  • promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment;
  • prioritize treatment for those with the most advanced liver disease and at greatest risk of mortality; and
  • recommend the preferred use of the nucleos(t)ide analogs with a high barrier to drug resistance (tenofovir and entecavir, and entecavir in children aged 2–11 years) for first- and second-line treatment.

These guidelines also recommend lifelong treatment for those with cirrhosis and those with high HBV DNA and evidence of liver inflammation, and regular monitoring for those on treatment, as well as those not yet on treatment for disease progression, indications for treatment and early detection of liver cancer.

In May 2016, the World Health Assembly adopted the first “Global health sector strategy on viral hepatitis, 2016-2020”. The strategy highlights the critical role of universal health coverage and sets targets that align with those of the Sustainable Development Goals.
The strategy has the vision to eliminate viral hepatitis as a public health problem. This is encapsulated in the global targets to reduce new viral hepatitis infections by 90% and reduce deaths due to viral hepatitis by 65% by 2030. Actions to be taken by countries and the WHO Secretariat to reach these targets are outlined in the strategy.

To support countries in achieving the global hepatitis elimination targets under the Sustainable Development Agenda 2030, WHO is working to:

  • raise awareness, promote partnerships and mobilize resources;
  • formulate evidence-based policy and data for action;
  • prevent transmission; and
  • scale-up screening, care and treatment services.

WHO recently published the “Progress report on HIV, viral hepatitis and sexually transmitted infections, 2019”, outlining its progress towards elimination. The report sets out global statistics on viral hepatitis B and C, the rates of new infections, the prevalence of chronic infections and mortality caused by these 2 high-burden viruses, and coverage of key interventions, all current at the end of 2016 and 2017.

Since 2011, together with national governments, partners and civil society, WHO has organized annual World Hepatitis Day campaigns (as 1 of its 9 flagship annual health campaigns) to increase awareness and understanding of viral hepatitis. The date of 28 July was chosen because it is the birthday of Nobel-prize winning scientist Dr Baruch Bloomberg, who discovered the hepatitis B virus and developed a diagnostic test and vaccine for it.

  • For World Hepatitis Day 2019, WHO is focusing on the theme “Invest in eliminating hepatitis” to highlight the need for increased domestic and international funding to scale up hepatitis prevention, testing and treatment services, in order to achieve the 2030 elimination targets.


References

Can a person with hepatitis B get pregnant?


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