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Guideline approved Antiviral Therapies in Adults and Children for Hepatitis B


Guideline approved Antiviral Therapies in Adults and Children for Hepatitis B
AASLD 2018 Hepatitis B Guidance is an update on  AASLD 2016 Practice Guidelines for Treatment of Chronic Hepatitis B and previous hepatitis B virus (HBV) guidelines from 2009 and it  includes  updates on treatment since the 2016 HBV guidelines including treatment of hepatitis B in special populations like persons with viral coinfections, acute hepatitis B, recipients of immunosuppressive therapy, and transplant recipients.
Guideline Approved Antiviral Therapies in Adults and Children
Drug Dose in Adults Use in Children Pregnancy Category Potential Side Effects Monitoring on Treatment
Preferred
Peg‐IFN‐α‐2a

(adult)

IFN‐α‐2b

(children)

180 mcg weekly ≥1 year dose: 6 million IU/m2three times weeklyd C Flu‐like symptoms, fatigue, mood disturbances, cytopenia, autoimmune disorders in adults, anorexia and weight loss in children Complete blood count (monthly to every 3 months)

TSH (every 3 months)

Clinical monitoring for autoimmune, ischemic, neuropsychiatric, and infectious complications

Entecavir 0.5 mg dailye ≥2 years dose: weight‐based to 10‐30 kg; above 30 kg: 0.5 mg dailye C Lactic acidosis (decompensated cirrhosis only) Lactic acid levels if there is clinical concern

Test for HIV before treatment initiation

Tenofovir dipovoxil fumarate 300 mg daily ≥12 years B Nephropathy, Fanconi syndrome, osteomalacia, lactic acidosis Creatinine clearance at baseline

If at risk for renal impairment, creatinine clearance, serum phosphate, urine glucose, and protein at least annually

Consider bone density study at baseline and during treatment in patients with history of fracture or risks for osteopenia

Lactic acid levels if there is clinical concern

Test for HIV before treatment initiation

Tenofovir alafenamide 25 mg daily There are insufficient human data on use during pregnancy to inform a drug‐associated risk of birth defects and miscarriage. Lactic acidosis Lactic acid levels if a clinical concern

Assess serum creatinine, serum phosphorus, creatinine clearance, urine glucose, and urine protein before initiating and during therapy in all patients as clinically appropriate

Test for HIV before treatment initiation

Nonpreferred
Lamivudine 100 mg daily ≥2 years

dose: 3 mg/kg daily to max 100 mg

C Pancreatitis

Lactic acidosis

Amylase if symptoms are present

Lactic acid levels if there is a clinical concern

Test for HIV before treatment initiation

Adefovir 10 mg daily ≥12 years C Acute renal failure

Fanconi syndrome

Lactic acidosis

Creatinine clearance at baseline

If at risk for renal impairment, creatinine clearance, serum phosphate, urine glucose, and urine protein at least annually

Consider bone density study at baseline and during treatment in patients with a history of fracture or risks for osteopenia

Lactic acid levels if the clinical concern

Telbivudine 600 mg daily B Creatine kinase elevation and myopathy

Peripheral neuropathy

Lactic acidosis

Creatine kinase if symptoms are present

Clinical evaluation if symptoms are present

Lactic acid levels if there is a clinical concern

  • Dose adjustments are needed in patients with renal dysfunction.
  • In 2015, the U.S. Food and Drug Administration replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually, and to date, only TAF includes these additional data.
  • Per package insert.
  • Peg‐IFN‐α‐2a is not approved for children with chronic hepatitis B, but is approved for treatment of chronic hepatitis C. Providers may consider using this drug for children with chronic HBV. The duration of treatment indicated in adults is 48 weeks.
  • Entecavir dose is 1 mg daily if the patient is lamivudine experienced or if they have decompensated cirrhosis.
  • Abbreviation: TSH, thyroid stimulating hormone.
 Efficacy of Approved First‐Line Antiviral Therapies in Adults with Treatment‐Naïve Chronic Hepatitis B and Immune‐Active Disease
HBeAg Positive Peg‐IFNa Entecavirb Tenofovir

Disoproxil Fumarateb

Tenofovir

Alafenamidec

% HBV‐DNA suppression (cutoff to define HBV‐DNA suppression)d 30‐42 (<2,000‐40,000 IU/mL)

8‐14 (<80 IU/mL)

61 (<50‐60 IU/mL) 76 (<60 IU/mL) 73 (<29 IU/mL)
% HBeAg loss 32‐36 22‐25 22
% HBeAg seroconversion 29‐36 21‐22 21 18
% Normalization ALT 34‐52 68‐81 68
% HBsAg loss 2‐7

11 (at 3 years posttreatment)

4‐5 8 1
HBeAg Negative Peg‐IFN Entecavir Tenofovir

Disoproxil Fumarateb

Tenofovir

Alafenamidec

% HBV‐DNA suppression (cutoff to define HBV‐DNA suppression)e 43 (<4,000 IU/mL)

19 (<80 IU/mL)

90‐91 (<50‐60 IU/mL) 93 (<60 U/mL) 90 (<29 IU/mL)
% Normalization ALTf 59 78‐88 76 81
% HBsAg loss 46 (at 3 years post treatment) 0‐1 0 <1

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Dr. Kamal Kant Kohli

Dr. Kamal Kant Kohli

A Medical practitioner with a flair for writing medical articles, Dr Kamal Kant Kohli joined Medical Dialogues as an Editor-in-Chief for the Speciality Medical Dialogues. Before Joining Medical Dialogues, he has served as the Hony. Secretary of the Delhi Medical Association as well as the chairman of Anti-Quackery Committee in Delhi and worked with other Medical Councils of India. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751
Source: self

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