Guideline approved Antiviral Therapies in Adults and Children for Hepatitis B

Written by Dr. Kamal Kant Kohli Kohli Published On 2018-04-05T19:20:58+05:30 | Updated On 5 April 2018 7:20 PM IST

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.

b 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.

c Per package insert.

d 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.

e 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

CBCChronic Hepatitis BComplete blood countcreatinine clearanceFanconi syndromehepatitis bLactic acidosisPancreatitisRenal Dysfunctionserum phosphorustenofovir disoproxil fumarateurine glucoseurine protein

Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

Dr. Kamal Kant Kohli Kohli