The document provides an overview of hepatitis C, detailing its causes, treatment options for both acute and chronic forms, and the mechanism of action of the antiviral drug Sovaldi (sofosbuvir). Sovaldi is a nucleotide analog that inhibits the hepatitis C virus's viral protein, aiding in virus elimination with high effectiveness when used in combination with other antivirals. Egypt has a particularly high prevalence of hepatitis C, underscoring its public health significance.

1. SOVALDI
Prepared by
Ahmed Younis

2. CONTENTS
1. Overview about Hepatitis C Virus
2. Treatment of Acute Hepatitis
3. Treatment of Chronic Hepatitis
4. Sovaldi definition
5. Mechanism of Action
6. Dosage and Administration
7. Why is Hepatitis C always treated
with at least two drug molecules?

3.  Hepatitis C is caused by single-stranded RNA virus. Its
size is 60nm and incubation period is 6 to 7 weeks.
 Hepatitis C virus (formerly non-A, non-B virus);
 The virus is an RNA virus and uses liver cells to create
copies of itself, killing those cells in the process.
 Having hepatitis C also increases the risk of developing
liver cancer.
Overview about Hepatitis C Virus

4.  Many infected people do not know they have the virus because
for most, there will be no symptoms and for others, the
symptoms may not show up for decades
 You may not know you have this infection until damage has
already been done to your liver
 There is no vaccine
 Egypt
Why Hepatitis C is health concern?
has the highest prevalence of HCV in the world,
estimated as 13.9–14.7 % . This means that ~13
million Egyptians are currently infected by HCV

5. Acute Hepatitis C Treatment
Genotype 1,2,3,4 Interferon Monotherapy
Interferon+Ribavirin
Peg-interferon
Monotherapy
Peg-interferon+Ribavirin
Treatment of Acute Hepatitis:
 Treatment of acute hepatitis C Include Alpha and Beta
interferon Monotherapy.
 It significantly decreases the number of patients that become
chronic carriers.

6. Treatment of Chronic Hepatitis:
1. Interferon (10 – 15% chance of clearing the virus from the blood)
2. Pegylated interferon : (About 40%)
3. Combination therapy:
Interferon & ribavirin(Virazole): Up to 40%
Pegylated interferon & ribavirin: Up to 50%
4. Older Direct acting Antivirals(DAA):
Boceprevir and Telprevir are Pretease inhibitors. Developed in May of 2011.
Boceprevir and teleprevir increased the cure rate for HCV genotype 1 to 70%.
A treatment regime with boceprevir or telaprevir, with interferon and ribavirin
lasts 24-48 weeks.

7. 4. New Direct acting Antivirals(DAA):
Sofsobuvir (SOF ,Sovaldi):
• SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B
polymerase inhibitor among the second generation of protease
inhibitors that directly attack the Hep C virus.
• Sofosbuvir was approved by FDA at 6th December 2013.
• Potent antiviral activity against HCV genotypes 1–6
• High barrier to resistance
• Once-daily, oral, 400-mg tablet

8. • When inside a Hepatitis C virus, sofosbuvir selectively attaches to the NS5B
polymerase viral protein which is a vital component virus replication.
• When sofosbuvir binds to the viral protein, it inhibits its further construction.
Thus the protein construction is stopped and the protein cannot complete its
normal function of replicating the virus.
• In such a way, the number of Hepatitis C viruses is stagnating and immune
system comes in to kill them off one at a time. Without the ability to recover from
the heavy losses against the immune system, HCV virus is doomed to be
eliminated, which heals the patient of Hepatitis C (viral load goes to zero).
Sofosbuvir mode of action

9. Mechanism of Action:

10. • One 400 mg tablet taken once daily with or without food.
• Should be used in combination with ribavirin or in combination
with pegylated interferon and ribavirin for the treatment of HCV.
Patient population Treatment Duration
Genotype 1,4 SOLVADI + peg-
interferon alfa +Ribavirin
12 weeks
Genotype 2 SOLVADI + Ribavirin 12 weeks
Genotype 3 SOLVADI + Ribavirin 24 weeks
Dosage and Administration:

11. • Sofosbuvir is an extremely effective molecule working against Hepatitis C
virus. In fact, sofosbuvir mechanism of action enables it to eliminate more
than 99.99% of the virus in a great majority of cases. However, that 0.01% of
the virus left could still prove problematic.
• This is why a second antiviral molecule is used to eliminate any virus that
might have survived. Modern Hepatitis C treatment regimen consist of
combination of primarily sofosbuvir, and secondarily ledipasvir, daclatasvir or
ribavirin.
• This is how we can ensure that the treatment is optimal and minimize the risk
of HPV developing sofosbuvir drug resistance.
Why is Hepatitis C always treated with at least
two drug molecules?