HEPATITIS B

1.
Generic name - Tenofovir disoproxil fumarate
Brand name - Tenofo-B
Classification - Nucleoside reverse transcriptase inhibitors (NRTIs)
Dosage/Frequency/Route - Adult HIV or chronic hepatitis B 300 mg once daily. Renal impairment CrCl
≥50 mL/min 300 mg every 24 hr, 30-49 mL/min 300 mg every 48 hr, 10-29 mL/min 300 mg every 72-96
hr. Hemodialysis patient 300 mg every 7 days or after a total of approx 12 hr of dialysis. Oral route
Mechanism of action - Tenofovir disoproxil fumarate requires initial diester hydrolysis for conversion to
tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate.
Indications - In combination w/ at least 2 other antiretroviral agents for the management of HIV infected
adults. Treatment of chronic hepatitis B in adults w/ compensated liver disease, w/ evidence of active
viral replication, persistent elevated serum ALT level & histological evidence of active inflammation &
fibrosis.
Contraindications - Hypersensitivity. Concomitant use w/ other tenofovir-containing combination
formulation or adefovir dipivoxil. Not recommended in children <18 yr.
Side effects/Adverse reactions - Mild GI effects particularly diarrhea, nausea & anorexia; raised serum-
amylase conc, pancreatitis; hypophosphatemia; skin rashes; peripheral neuropathy, headache, dizziness,
insomnia, depression, asthenia, sweating, myalgia; raised liver enzymes, hypertriglyceridemia,
hyperglycemia, neutropenia; renal impairment, acute renal failure; effects on renal proximal tubules
including Fanconi syndrome; lactic acidosis, usually associated w/ severe hepatomegaly & steatosis.

2.
Generic name - Tenofovir alafenamide
Brand name - Vemlidy
Classification - Nucleoside reverse transcriptase inhibitors (NRTIs)
Dosage/Frequency/Route - Adult & adolescent ≥12 yr & at least 35 kg 1 tab once daily. Oral route
Mechanism of action - The antiviral properties of tenofovir are due to its inhibition of HBV polymerase,
which, in turn, inhibits DNA synthesis and viral replication.
Indication - Chronic hepatitis B in adults & adolescents (≥12 yr & at least 35 kg).
Contraindication - Hypersensitivity
Side effects/Adverse reactions - Headache. Diarrhea, vomiting, nausea, abdominal pain/distention,
flatulence; fatigue; dizziness; rash, pruritus; increased ALT; arthralgia.
3.
Generic name - Entecavir
Brand name - Baraclude
Classification - Nucleoside analogs
Dosage/Frequency/Route - Adults and children 16 years of age and older—0.5 to 1 milligram (mg) or 10
to 20 milliliters (mL) once per day. Children 2 years of age and older weighing more than 30 kilograms
(kg)—0.5 to 1 milligram (mg) or 10 to 20 milliliters (mL) once per day. Children 2 years of age and older
weighing 10 to 30 kg—dose is determined by body weight, usually between 3 to 20 milliliters (mL) once
a day. Children younger than 2 years of age—Use and dose must be determined by your doctor. Oral
route
Mechanism of action - By competing with the natural substrate deoxyguanosine triphosphate, entecavir
functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt): (1) base
priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3)
synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated
into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity.
Indication - For the treatment of chronic hepatitis B virus infection in adults with evidence of active viral
replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or
histologically active disease.
Contraindication - Patients with previously demonstrated hypersensitivity to entecavir or any
component of the product.
Side effects/Adverse reactions - Headache, fatigue, dizziness, and nausea.

4.
Generic name - Telvibudine
Brand name - Sebivo
Classification - Antiviral drug
Dosage/Frequency/Route - Adult: 600 mg once daily. Oral route
Mechanism of action - Telbivudine 5'–triphosphate inhibits HBV DNA polymerase (reverse transcriptase)
by competing with the natural substrate, thymidine 5'–triphosphate.
Indication - Chronic hepatitis B
Contraindication - Hypersensitivity. Lactation. Concurrent use w/ peginterferon alfa-2a.
Side effects/Adverse reactions - Cough, dizziness, fatigue, GI effects (e.g. abdominal pain, diarrhoea,
nausea, vomiting, dyspepsia), rash, arthralgia, myalgia, myopathy, malaise, back pain, nasopharyngitis,
headache, flu or flu-like symptoms, insomnia; increased serum amylase, lipase, creatine phosphokinase,
alanine aminotransferase levels; peripheral neuropathy, rhabdomyolysis.
Potentially Fatal: Lactic acidosis, severe hepatomegaly w/ steatosis.
5.
Generic name - Adefovir dipivoxil
Brand name - Hepsera
Classification - Nucleotide analogs
Dosage/Frequency/Route - Adult: 10 mg once daily. Oral route
Mechanism of action - Inhibits HBV DNA polymerase (reverse transcriptase) by competing with the
natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its
incorporation into viral DNA.
Indication - Chronic hepatitis B
Contraindication - Hypersensitivity. Lactation.
Side effects/Adverse reactions - Nephrotoxicity (chronic use); GI effects (e.g. nausea, flatulence,
diarrhoea, dyspepsia, vomiting, abdominal pain, pancreatitis), headache, asthenia, pruritus, skin rash,
proximal renal tubulopathy, Fanconi syndrome, hypophosphatemia, raised liver enzymes and serum
creatinine concentrations, renal failure, renal insufficiency, myopathy, osteomalacia.
Potentially Fatal: Lactic acidosis, severe hepatomegaly w/ steatosis.

6.
Generic name - Lamivudine
Brand name - Zeffix
Classification - Nucleoside analogues
Dosage/Frequency/Route - 100 mg once daily. Oral route
Mechanism of action - This Lamivudine competitively inhibit HIV reverse transcriptase enzyme which is
responsible for the conversion of viral RNA to pro viral DNA and is then added to host cell chromosome.
Lamivudine triphosphate terminates elongation of pro viral DNA and results in inhibition of viral
replication.
Indication - Indicated for the treatment of patients ≥ 16 years of age with chronic hepatitis B and
evidence of hepatitis B virus (HBV) replication.
Contraindication - Contraindicated in patients with known hypersensitivity to Zeffix or to any ingredient
of the preparation.
Side effects/Adverse reactions - Malaise and fatigue, respiratory tract infections, headache, abdominal
discomfort and pain, nausea, vomiting and diarrhea.

7.
Generic name - Peginterferon alfa-2a
Brand name - Pegasys
Classification - Interferons
Dosage/Frequency/Route - 180 mcg SC once weekly for 48 weeks. Parentheral route
Mechanism of action - It binds to and activates human type 1 interferon receptors causing them to
dimerize. This activates the JAK/STAT pathway. Activation of the JAK/STAT pathway increases expression
of multiple genes in multiple tissues involved in the innate antiviral response.
Indication - as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is
indicated for the treatment of adults with CHC and compensated liver disease.
Contraindication - Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction,
anaphylaxis, or Stevens-Johnson syndrome to alpha interferons, including PEGASYS, or any of its
components. Autoimmune hepatitis. Hepatic decompensation (Child-Pugh score greater than 6 [class B
and C]) in cirrhotic patients before treatment. Hepatic decompensation with Child-Pugh score greater
than or equal to 6 in cirrhotic CHC patients coinfected with HIV before treatment.
Side effects/Adverse reactions - Flu-like symptoms (headache, muscle aches, tiredness and fever) usually
lessen after the first few weeks of treatment, fatigue, injection site reactions (bruising, itching,
irritation), poor appetite, and nausea.

8.
Generic name - Interferon Alpha
Brand name - Intron A
Classification - Interferons
Dosage/Frequency/Route - The recommended dose for the treatment of chronic hepatitis B is 30 to 35
million IU per week, administered subcutaneously or intramuscularly, either as 5 million IU daily (QD) or
as 10 million IU three times a week (TIW) for 16 weeks. Parentheral route
Indication - Indicated for the treatment of chronic hepatitis B in patients 1 year of age or older with
compensated liver disease.
Contraindication - Hypersensitivity. History of severe cardiac disease (e.g. recent MI, uncontrolled CHF,
severe arrhythmic disorders), epilepsy and/or compromised CNS function, autoimmune hepatitis or
history of autoimmune disease, immunosuppressed transplant recipients, rapidly progressive visceral
disease, pre-existing thyroid disease (unless it can be controlled with conventional treatment); current
or history of severe psychiatric condition (e.g. severe depression, suicidal ideation or suicide attempt)
particularly in children and adolescents. Severe renal or hepatic impairment (including decompensated
liver disease or that caused by metastases).
Side effects/Adverse reactions - Bruising, bleeding, pain, redness, swelling, or irritation in the place you
injected. Change in ability to taste and hair loss.
HEPATITIS C

9.
Generic name - Elbasvir/Grazoprevir
Brand name - Zepatier
Classification - Direct-acting antiviral (DAA)
Mechanism of action – It targets the NS5A protein, which effectively prevents the transcription of the
HCV RNA and also prevents virion assembly.
Dosage/Frequency/Route - Adults and children 12 years of age and older or weighing 30 kilograms (kg)
or more—One tablet once a day. Each tablet contains 50 milligrams (mg) of elbasvir and 100 mg of
grazoprevir. Children younger than 12 years of age weighing less than 30 kg—Use and dose must be
determined by your doctor. Oral route
Indication - Indicated for use with or without ribavirin for the treatment of chronic HCV genotypes 1 or 4
infection in adults.
Contraindication - Contraindicated for use in patients with moderate to severe hepatic impairment
(Child-Pugh Class B or C).
Side effects/Adverse reactions - Headache, nausea, diarrhea, sleep problems (Insomnia) and fatigue.

10.
Generic name - Glecaprevir/Ledipasvir
Brand name - Mavyret
Classification - HCV NS5A Inhibitors
Mechanism of action - Combination of 2 direct-acting antiviral agents, with distinct mechanisms of
action.
Dosage/Frequency/Route - 3 tablets (ie, 300 mg/120 mg total dose) PO qDay. Oral route
Indication - Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1,
2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
Contraindication - contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh
B or C) or those with any history of prior hepatic decompensation and is contraindicated with atazanavir
or rifampin.
Side effects/Adverse reactions - Nausea, headache, fatigue (lack of energy), and diarrhea.
11.
Generic name - Sofosbuvir/Ledipasvir
Brand name - Harvoni
Classification - HCV NS5A Inhibitors; HCV Polymerase Inhibitors
Dosage/Frequency/Route - In patients with HCV genotype 1, 4, 5, or 6 infections: 1 tab once daily, with
or without ribavirin. If vomiting occurs within 5 hours of dosing, an additional tab is needed. Treatment
duration: 8 or 12 weeks, or 24 weeks if necessary (varies according to HCV genotype and treatment
regimen used).
Child: ≥12 years or weighing ≥35 kg: 1 tab once daily. Treatment duration varies according to HCV
genotype and treatment regimen used. Oral route
Indication - Indicated for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged
3 years and above.
Contraindication - When co-administered with ribavirin, its contraindication also apply to this
combination regimen (eg, Pregnancy Cat.X).
Side effects/Adverse reactions - Fatigue, headache, asthenia, nausea, diarrhea, insomnia.

12.
Generic name - Sofosbuvir/Velpatasvirvir
Brand name - Epclusa
Classification - HCV NS5A Inhibitors; HCV Polymerase Inhibitors
Mechanism of action The sofosbuvir component of the drug is an inhibitor of the HCV NS5B RNA
dependent RNA polymerase, which undergoes intracellular metabolism to form uridine analogue
triphosphate and inhibits the viral replication by incorporating into HCV RNA and acts as a chain
terminator.
Dosage/Frequency/Route - 1 tablet (400 mg sofosbuvir/100 mg velpatasvir) PO qDay. Oral route
Indication - indicated for the treatment of adults and pediatric patients 3 years of age and older with
chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection.
Contraindication - is contraindicated in patients for whom
ribavirin is contraindicated.
Side effects/Adverse reactions - Headache and fatigue.
Hepatitis E

13.
Generic name - Peginterferon alfa-2a
Brand name - Pegasys
Classification - Interferons
Dosage/Frequency/Route - 180 mcg SC once weekly for 48 weeks. Parentheral route
Mechanism of action - It binds to and activates human type 1 interferon receptors causing them to
dimerize. This activates the JAK/STAT pathway. Activation of the JAK/STAT pathway increases expression
of multiple genes in multiple tissues involved in the innate antiviral response.
Indication - as part of a combination regimen with other hepatitis C virus (HCV) antiviral drugs, is
indicated for the treatment of adults with CHC and compensated liver disease.
Contraindication - Known hypersensitivity reactions such as urticaria, angioedema, bronchoconstriction,
anaphylaxis, or Stevens-Johnson syndrome to alpha interferons, including PEGASYS, or any of its
components. Autoimmune hepatitis. Hepatic decompensation (Child-Pugh score greater than 6 [class B
and C]) in cirrhotic patients before treatment. Hepatic decompensation with Child-Pugh score greater
than or equal to 6 in cirrhotic CHC patients coinfected with HIV before treatment.
Side effects/Adverse reactions - Flu-like symptoms (headache, muscle aches, tiredness and fever) usually
lessen after the first few weeks of treatment, fatigue, injection site reactions (bruising, itching,
irritation), poor appetite, and nausea.