علاج فيرس سي المحتمل نزوله الشهر المقبل بمصر بتكلمفة 900 دولار لمدة 12 اسبوع
FDA Approves Sovaldi ®
- On 6th December 2013, The U.S .
Food and Drug Administration
(FDA) has approved Sovaldi ® (sofosbuvir) 400 mg tablets, a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen.
Efficacy
- Efficacy has been established in subjects with hepatitis C virus (HCV) genotypes 1, 2, 3 or 4 infections, and to treat HCV and HIV co-infected patients.
- The combination therapy includes either ribavirin (RBV) alone or Ribavirin and peg-interferon (PEG-IFN) alfa.
Drug category
- Sofosbuvir acts against HCV and is categorized as a Direct-Acting Antiviral agent (DAA).
HCV genotypes
- Hepatitis C virus (HCV) is a major cause of chronic liver disease, with an estimated 170 million people infected worldwide.
- Hepatitis C is divided into six distinct genotypes throughout the world with multiple subtypes in each genotype class.
- A genotype is a classification of a virus based on the genetic material in the RNA strands of the virus.
- Generally, patients are only infected with one genotype.
- Each genotype has the ability to mutate very quickly and become immune to current treatments, which explains why chronic Hepatitis C is so difficult to treat.
- Genotype 1 is the most common type of Hepatitis C genotype in the United States and the most difficult to treat.
Dose
- One 400 mg tablet taken once daily with or without food.
- Should be used in combination with ribavirin or in combination with peg-interferon and ribavirin for the treatment of CHC.
- If you miss a dose, take the missed dose as soon as you remember the same day. Do not take more than one tablet (400 mg) in a day. Take your next dose at your regular time the next day
Recommended combination therapy
Genotype 1 or 4 Sovaldi + peg-interferon alfa + ribavirin 12 weeks
Genotype 2 Sovaldi + ribavirin 12 weeks
Genotype 3 Sovaldi + ribavirin 24 weeks
Pharmacokinetics
- Sofosbuvir is a prodrug that is metabolized by the liver to the active antiviral agent (Active triphosphate catabolite).
- Given orally (Once daily).
- Maximum plasma concentration in about 0.5 to 2 hours.
- Plasma protein binding amount of 61-65%.
- eliminated by three routes: urine (80%), feces (14%), and respiration (2.5%).
Mechanism of action
Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication.
- Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the
pharmacologically active uridine analogue triphosphate, which can be
incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.
Side effects
- The most common side effects (greater than or equal to 20%, all grades) observed with Sovaldi ®
in combination with ribavirin:
- Fatigue
- Headache.
- The most common side effects observed with Sovaldi ®
in combination with peg-interferon alfa and ribavirin:
- Fatigue
- Headache
- Nausea
- Insomnia
- Anemia
Warning and recaution
- Pregnancy:
- Ribavirin may cause birth defects and fetal death and animal studies have shown interferons have abortifacient effects.
- Avoid pregnancy in female patients and female partners of male patients.
- Patients must have a negative pregnancy test prior to initiating therapy.
- Females and males must use two effective forms of birth control during treatment and for the 6 months after treatment.
Prepared By:
- Pharmacist:
Dhshan Hassan Dhshan
- Graduated from: Faculty of Pharmacy Al-azhar Universty
تعليقات
إرسال تعليق