New Drugs for Treatment of Hepatitis C: Victrelis, Incivek, Olysio, Sovaldi

Category: Viral Infections by Omudhome Ogbru, PharmD - December 8, 2013 | Views: 13115 | Likes: 1 | Comment: 2

Healthcare Social Network. Share Knowledge, Be Discovered, Find Opportunities. Join Now

New Hepatitis C Drugs. Incivek, Victrlis, Olysio, Sovaldi,

Hepatitis C Virus Infection Facts

Hepatitis C virus causes liver inflammation leading to reduced liver function and liver failure. Approximately 3.2 million people in the United States have chronic hepatitis C (HCV) infection and it is the most common blood borne disease. It is transmitted through exposure to infected blood from blood transfusions or injected drugs. Sexual transmission, occupational, and perinatal exposure also occur.  Here are some other facts about hepatitis C infection.

  • 60-70% of infected individuals do not have symptoms but can still transmit the virus to others.
  • 70-85% of infected people develop chronic hepatitis C.
  • 15-25% of persons infected eliminate HCV from their blood without any treatment.
  • 60-70% of those with HCV infection develop chronic liver disease.
  • 1-5% of people infected with HCV will die from liver cancer or cirrhosis.
  • Chronic HCV infection is the leading reason for liver transplants in the Unites States.
  • There are 6 HCV genotypes (genotypes 1-6) and more than 50 subtypes. Genotype 1 is the most common HCV genotype in the United States. 
  • The risk of HCV infection after accidental needle stick or sharps exposure is 0-10%. 
  • About 4% of infants born to HCV-infected mothers become infected with HCV.  

Ribavirin and Interferon for Hepatitis C Treatment

A combination of pegylated interferon and ribavirin was the preferred treatment for HCV infection prior to the approval of hepatitis C polymerase and protease inhibitors. Interferon and ribavirin combination treatment produce undetectable HCV [sustained virologic response (SVR)] in 40-80% of infected individuals after 24 weeks of treatment. Effectiveness varies depending on the HCV genotype. The rate of undetectable HCV is 50% for patients infected with HCV genotype 1 which is the most common genotype in the United States. 

Side effects from combination ribavirin and interferon treatment include:

  • Fatigue, headache, fever, and muscle pain
  • Nausea, weight loss, and diarrhea
  • Insomnia, depression, and psychosis
  • Skin rash and hair loss 
  • Low red (anemia) and white (neutropenia) blood cells, low blood platelets (thrombocytopenia)


Also Read: Are New Hepatitis C Virus (HCV) Treatments Too Expensive? 
 

New Drugs for Treatment of Hepatitis C

Since 2011 the FDA has approved 4 direct-acting antiviral drugs for treatment of hepatitis C virus. Victrelis (boceprevir) and Incivek (telaprevir) are protease inhibitors approved in 2011. In November 2013 the FDA approved Olysio (simeprevir) another protease inhibitor and in December 2013 Sovaldi (sofosbuvir), a nucleotide analog inhibitor, was approved. These new hepatitis treatments advance the treatment of hepatitis by providing better antiviral response rates than interferon and ribavirin combinations alone.

Victrelis (boceprevir) 200 mg Capsules

Victrelis is an HCV protease inhibitor used in combination with peginterferon alpha and ribavirin for treatment of chronic hepatitis C infection in adults who are receiving treatment for the first time or have failed interferon and ribavirin therapy. It reduces the activity of hepatitis C virus protease enzymes which leads to the formation of defective viruses that are unable to multiply in the liver. As a result the hepatitis C viral load decreases. In clinical trials Victrelis reduced hepatitis C viral loads to undetectable levels in 59 to 66% of patients compared to 23 to 38% of patients treated with only combination peginterferon and ribavirin. The dose is 800 mg administered orally 3 times daily (every 7-9 hours) with a meal or snack. Its side effects are weakness, anemia, nausea, headache, abnormal taste sensation, and reduced number of platelets and white blood cells. The wholesale price for Victrelis is $26,400 for 24 weeks, $35,200 for 32 weeks and $48,400 for 48 weeks of treatment.

Incivek (telaprevir) 375 mg Tablets

Incivek is also a protease inhibitor with a similar mechanism of action as Victrelis. It is combined with peginterferon alfa and ribavirin for the treatment of adult patients  with genotype 1 hepatitis C infection and compensated liver disease, including cirrhosis, who are receiving treatment for the first time or have failed or did not adequately respond to interferon and ribavirin therapy. In treatment naive patients 79% in the Incivek group compared to 46% of the group that only received peginterferon and ribavirin achieved undetectable levels of hepatitis C virus. The usual dose is 1125 mg (three 375 mg tablets) twice daily with food. Its side effects include rash, itching, anemia, nausea, vomiting, diarrhea, loss of taste, hemorrhoids, fatigue, anal itching, and severe skin reactions. The cost of Incivek is $66,155 for 12-weeks. 

Olysio (simeprevir) 150 mg Capsules

Olysio is the latest HCV protease inhibitor approved by the FDA. It has a similar mechanism of action as Incivek and Victrelis. It is approved for use in combination with peginterferon alfa and ribavirin in HCV genotype 1 infected subjects with compensated liver disease, including cirrhosis. In drug naive patients 88% achieved undetectable levels of HCV after 12 weeks of Olysio treatment. 78% had undetectable HCV virus at Week 4 and in this group the response rate at week-12 was 90%. The recommended dose is 150 mg taken once daily with food for 12 weeks in combination with peginterferon alfa and ribavirin. After the initial 12 weeks, treatment is continued with 12 or 36 additional weeks of peginterferon alfa and ribavirin depending on prior response. The most common side effects are rash, photosensitivity (sun sensitivity), itching, and nausea. Shortness of breath (dyspnea) and muscle pain (myalgia) also occur. The wholesale price for a 12 week course of Olysio is $66,360. 

Sovaldi (sofosbuvir) 400 mg Tablets

Sovaldi is the most recent FDA approved direct-acting antiviral drug for treatment of hepatitis C virus. It is a nucleotide analog polymerase inhibitor approved for treatment of chronic hepatitis C in combination with ribavirin or ribavirin plus peginterferon. Sovaldi disrupts replication of HCV RNA leading to a reduction in the multiplication of HCV. 

Sovaldi has the broadest indication for HCV treatment and is a significant advancement in the treatment of chronic hepatitis C. It is effective for treating:

  • HCV genotype 1, 2, 3 or 4 infection 
  • Those with hepatocellular carcinoma awaiting liver transplantation
  • Individuals with HCV/HIV-1 co-infection

In clinical trials Sovaldi produced sustained virologic response in 50 to 92% of patients. The recommended dose is 400 mg once daily with or without food in combination with ribavirin or ribavirin plus peginterferon alpha. Treatment duration is 12 weeks for genotype 1, 2, or 4 infection and 24 weeks for genotype 3 treatment. Individuals with hepatocellular carcinoma and waiting for liver transplant are treated for 48 weeks or until liver transplantation. Side effects of Sovaldi include fatigue, headache, nausea, diarrhea, insomnia, anemia (low red blood cells), rash, and itching. The wholesale price of Sovaldi in the United States is $28,000 for 28 tablets. 

Conclusion

Since 2011 four direct-acting antiviral drugs have been approved for treatment of hepatitis C. These new drugs have higher sustained virology response rates and represent significant advancement in the treatment of HCV. They may change the course of the disease. Although they may seem expensive, their price should be weighed against their benefit in reducing the burden of disease, the potential to prevent liver failure and transplantation, and saving the life of HCV infected individuals.   

Resources

CDC Hepatitis C Information for Health Professionals

Victrelis (boceprevir) 200 mg Capsules Prescribing Information

Incivek (telaprevir) 375 mg Tablets Prescribing Information

Olysio (simeprevir) 150 mg Capsules Prescribing Information 

Sovaldi (sofosbuvir) 400 mg Tablets Prescribing Information

 

Comment on this article or post an article by joining the RxEconsult community.

Please Share on Your Social Networks

By Dr. Omudhome Ogbru

Articles Widget

More Articles by Omudhome Ogbru, PharmD