Sofosbuvir 400 mg
What is Hopetavir?
Hopetavir is an antiviral drug used to treat chronic hepatitis C (Hep C) infection in adults. Active ingredient in Hopetavir is Sofosbuvir 400 mg.
Hopetavir should not be taken alone. It should be taken in combination with Celbarin (Ribavirin 200 mg). It is not known if Hopetavir is safe and effective in children under 18 years of age.
With Hopetavir, there’s hope that to put Hep C behind.
What Sofosbuvir does?
Sofosbuvir directly targets the Hep C virus to stop it from making copies of itself in the liver. Sofosbuvir attaches itself to the genetic information, called RNA, to block the virus from multiplying.
Can the patients take Sofosbuvir if he/she was not cured with a previous Hep C treatment?
Patients who have not been cured with previous interferon-based treatments can take Sofosbuvir combination regimens. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.
Can the patients take Sofosbuvir if he/she is unable to take interferon treatment?
Sofosbuvir in combination with Ribavirin for 24 weeks can be considered for Hep C patients with GT1 infection who are interferon ineligible. Sofosbuvir combination therapy for Hep C patients with GT2 and GT3 infection does not include interferon.
Can the patients take Sofosbuvir if he/she has cirrhosis?
For some, Sofosbuvir combination therapy can cure chronic Hep C even if the patients have cirrhosis.
Can the patients take Sofosbuvir if he/she has liver cancer and is awaiting a liver transplant?
Certain patients with chronic Hep C who have liver cancer and are awaiting a liver transplant can take Sofosbuvir + Ribavirin for up to 48 weeks or until the time of liver transplantation. This is to prevent reinfection with Hep C after transplant.
Can the patients take Sofosbuvir if he/she has Hep C and is also infected with HIV?
The Sofosbuvir dosing and treatment regimens for people co-infected with Hep C and HIV are the same as Sofosbuvir dosing and treatment regimens for people with Hep C who don’t have HIV.
Sofosbuvir combination therapy cure rates in clinical studies
Sofosbuvir is a groundbreaking hepatitis C (Hep C) treatment. Clinical studies have shown that Sofosbuvir combination therapy can be effective for people with genotypes 1, 2, 3, and 4.
The table below includes the percentages of patients, in Sofosbuvir clinical studies, who were cured of the Hep C virus. Cure means the Hep C virus is not detected in the blood when measured 3 months after treatment is completed.
|1 OR 4||Sofosbuvir + Ribavirin + Peginterferon alfa||89% / 96%|
|2||Sofosbuvir + Ribavirin||93%|
|3||Sofosbuvir + Ribavirin||84%|
Sofosbuvir combination therapy regimens
|HCV monoinfected & HCV / HIV-1 co-infected||Treatment||Duration|
|Patients with genotype 1 or 4 CHC||Sofosbuvir + Peginterferon alfa + Ribavirin||12 Weeks|
|Patients with genotype 2 CHC||Sofosbuvir + Ribavirin||12 Weeks|
|Patients with genotype 3 CHC||Sofosbuvir + Ribavirin||24 Weeks|
The table above applies to people with Hep C with or without HIV-1. For genotype 1 patients who cannot take Peginterferon alfa, a 24-week regimen of Sofosbuvir plus ribavirin may be considered.
How will the patients know if he/she is cured?
Cure means the Hep C virus is not detected in the blood when measured with a blood test by your healthcare provider 3 months after treatment is completed.
What is the most important information about Sofosbuvir?
Sofosbuvir combination therapy with Ribavirin or Peginterferon alfa and Ribavirin can cause birth defects or death to unborn baby. If the patients or his sexual partner is pregnant or plans to become pregnant, medicines should not be taken.
- If the patients or his sexual partner must use 2 effective forms of birth control and should not become pregnant while being treated with Sofosbuvir combination therapy and for 6 months after treatment is over.
- If the patients or his partner can become pregnant then they must have a pregnancy test before starting treatment with Sofosbuvir combination therapy, every month while being treated, and for 6 months after treatment ends.
- Doctors should be immediately notified if a pregnancy occurs while taking or within 6 months after stop taking Sofosbuvir combination therapy.
- The patients should not take Sofosbuvir alone. Sofosbuvir should be used together with ribavirin or in combination with Peginterferon alfa and Ribavirin to treat chronic hepatitis C infection.
When is Sofosbuvir contraindicated?
The same contraindications that pertain to Peginterferon and Ribavirin also apply to the Hopetavir combination treatment. This combination treatment is contraindicated in pregnant women or those that may become pregnant as well as men whose female partner is pregnant, due to the risks for birth defects and fetal death associated with Ribavirin.
What are the adverse reaction to Sofosbuvir?
In the clinical studies the most common adverse reactions when Sofosbuvir was used in combination with Ribavirin were fatigue and headache. The most common adverse effect when Sofosbuvir was used in combination with Peginterferon alfa and Ribavirin were fatigue, headache, nausea, insomnia and anemia.
Although less common, in addition to the adverse reactions mentioned above, the following adverse reactions were also reported:
- Pruritus (itching)
- Asthenia (weakness)
- Decreased Appetite
- Influenza like illness
- Pyrexia (fever)
- Neutropenia (lowered neutrophils - type of white blood cell that surrounds and destroys bacteria)
- Myalgia (muscle pain)
Less than 1% of the subjects in the clinical study receiving Sofosbuvir combination therapy reported:
- Hematologic effects - Pancytopenia (particularly in subjects receiving concomitant Pegylated interferon).
- Psychiatric disorders - Severe Depression (particularly in subjects with pre-existing history of psychiatric illness), including suicidal ideation and suicide.