SOFOSBUVIR

A Drug study presented to the

Faculty of the Nursing Department
San Pedro College, Davao City
MRS. SORAIDA A. BASALLAJE, RN, MN

In Partial Fulfillment of the

Requirements in NCM 216 – RLE
GI/ENDO/METABOLISM ROTATION

Submitted by:
NICOLE KEESHA J. MATA, ST. N
BSN 3G – Group 4 Subgroup 3

January 23, 2021

Generic Name: Sofosbuvir

Brand Name: Sovaldi, Harvoni, Vosevi,

Classification: HCV Polymerase Inhibitors

Pregnancy Category B
Pregnancy Category X

Mode of Action:
Sofosbuvir inhibits the hepatitis C NS5B protein. Sofosbuvir appears to
have a high barrier to the development of resistance. Sofosbuvir is a
prodrug of the protide type, whereby the active phosphorylated nucleotide
is granted cell permeability and oral bioavailability.

Route and Dosage:

Oral
Adult: As combination therapy with antiviral treatment regimen in
patients with chronic HCV genotype 1, 2, 3, or 4: 400 mg once
daily. Treatment duration may vary depending on genotype and
treatment regimen.
Child: As combination therapy with antiviral treatment regimen in
patients with chronic HCV genotype 2 or 3: ≥12 years or weighing
≥35 kg: Same as adult dose.
Indication: Indicated for the treatment of genotype 1, 2, 3 or 4 chronic
hepatitis C virus (HCV) infection as a component of a
combination antiviral treatment regimen.

Contraindication:
When sofosbuvir is used in combination with peginterferon alfa plus
ribavirin, or with ribavirin alone, all contraindications that pertain to
peginterferon alfa or ribavirin will apply to the combination regimens. The
use of sofosbuvir with amiodarone is not recommended due to the risk of
developing serious symptomatic bradycardia; this risk is pronounced in
persons also taking a beta-blocker and for those with underlying cardiac
comorbidities or advanced liver disease.

Side Effects:

Tiredness, headache, nausea, diarrhea, itchy skin, difficulty sleeping, or

irritability may occur.

Adverse Effects:

Gastrointestinal disorders: Nausea, diarrhea.

General disorders and administration site conditions: Fatigue,
weakness, irritability.
Immune system disorders: angioedema.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Insomnia, depression.
Respiratory, thoracic and mediastinal disorders: Cough, dyspnea,
nasopharyngitis.
Skin and subcutaneous tissue disorders: Rash

Drug Interaction:

Antiarrhythmic: amiodarone
Coadministration of amiodarone with SOVALDI in combination with
another direct antiviral agent may result in serious symptomatic
bradycardia.
Anticonvulsants: carbamazepine, phenytoin, phenobarbital,
oxcarbazepine

Coadministration of SOVALDI with carbamazepine, phenytoin,

phenobarbital or oxcarbazepine is expected to decrease the concentration
of sofosbuvir, leading to reduced therapeutic effect of SOVALDI.
Antimycobacterials: rifabutin, rifampin, rifapentine

Coadministration of SOVALDI with rifabutin or rifapentine is expected to

decrease the concentration of sofosbuvir, leading to reduced therapeutic
effect of SOVALDI.
Herbal Supplements: St. John’s wort (Hypericum perforatum)

Coadministration of SOVALDI with St. John’s wort, an intestinal P-gp

inducer, is not recommended as they may significantly decrease
sofosbuvir plasma concentration, reducing its therapeutic effect.
HIV Protease Inhibitors: tipranavir/ritonavir

Coadministration of SOVALDI with tipranavir/ritonavir is expected to

decrease the concentration of sofosbuvir, leading to reduced therapeutic
effect of SOVALDI.

Nursing Responsibilities:
1. Monitor vital signs before and frequently during therapy.

2. Instruct patient to take medication as directed around the clock in order

for it to be effective in treating hepatitis. Take missed doses as soon as

remembered; check with health care professional if more than 1 dose is

missed. Consult health care professional prior to discontinuing medication.

3. Instruct patient to take this medication by mouth with or without food as

directed by your doctor, usually once daily.

4. Instruct patient to pour the pellets directly into his/her mouth. Then,
Swallow the pellets without chewing.
5. Advise patient to drink water after swallowing the pellets if needed.

6. Instruct patient to take this drug at evenly spaced intervals. To help the
patient remember, and take it at the same time each day.

7. Advise patient to continue to take sofosbuvir and your other antiviral

medication(s) for the full length of time prescribed, even if your symptoms
disappear after a short time. Stopping any of the drugs too early may
result in a return of the infection.
8. Instruct patient to avoid taking an herbal supplement containing St.
John's wort as they may significantly decrease sofosbuvir plasma
concentration, reducing its therapeutic effect.

9. Store this medicine in the original container at room temperature away

from moisture and heat.

10. Instruct patient not to open the packet of oral pellets until you are
ready to use the medicine.
References:

Gilead Sciences. (2016). SOVALDI (sofosbuvir tablets). Retrieved January

23, 2021, from https://www.accessdata.fda.gov/drugsatfda_

docs/label/2015/204671s002lbl.pdf

Thorton, P., DipPharm. (2020, September 24). Sofosbuvir : Uses, Side

Effects, Dosage, Warnings. Retrieved January 23, 2021, from

https://www.drugs.com/sofosbuvir.html

WebMD. (2021). Sofosbuvir Oral : Uses, Side Effects, Interactions,

Pictures, Warnings & Dosing. Retrieved January 23, 2021, from
https://www.webmd.com/drugs/2/drug-165497/sofosbuvir-
oral/details