Hepatitis C can be "cured"

More than 3 million people in the United States have chronic hepatitis C and each year about 17,000 become infected with the virus.¹ Hepatitis C is a viral infection that leads to inflammation (swelling) of the liver. If hepatitis C becomes chronic (long-lasting), it can lead to serious health problems. These problems include cirrhosis (scarring of the liver), liver failure and liver cancer.^1,2

The good news is that unlike many other viral diseases, hepatitis C can often be "cured". This means it is cleared from the body, which is called a Sustained Virologic Response or SVR. An SVR means that for a period of 6 months after your treatment ends, a blood test cannot detect any hepatitis C virus in your body.²

The goal of treatment is to achieve a SVR. Today, various treatment options exist for Hepatitis C and many people with hepatitis C are "cured" every year.²

• The most frequently used medication belongs to a class of drugs called interferons. These drugs are given by injection. Interferons have been used for over 15 years to treat hepatitis C and other diseases caused by viruses.²
  
  
• Ribavirin is an oral (taken by mouth as a capsule or tablet) antiviral drug that is usually prescribed along with an interferon. It increases the overall effectiveness of interferon treatment.²
  
  
• A new class of drugs for treating hepatitis C has just become available. Known as "direct acting antivirals" (DAAs), they will not replace interferon and ribavirin. Instead, DAAs will be given in combination with them.

Your healthcare provider can give you more information about these drugs based on your individual situation. Being informed is the first step in managing hepatitis C. If you have been diagnosed with hepatitis C, speak with your healthcare provider about treatment options.

To learn more about Ribasphere RibaPak, click here.

References:

1. Centers for Disease Control and Prevention. Hepatitis C. General Information. Atlanta, GA: Centers for Disease Control and Prevention, US Dept of Health and Human Services; June 2011. Publication No. 21-1075.
2. National Institutes of Health; US Department of Health and Human Services. Chronic Hepatitis C: Current Disease Management. Bethesda, MD: National Institutes of Health; 2010. NIH Publication 10-4230.

INDICATION

Ribasphere (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Ribasphere (ribavirin, USP) is contraindicated in:

• Patients with known hypersensitivity to Ribasphere (ribavirin, USP) or to any component of the tablet.
• Women who are pregnant.
• Men whose female partners are pregnant, plan to become pregnant, or are not using contraception.
• Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).
• In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.

Ribasphere (ribavirin, USP) and peginterferon alfa-2a combination therapy is contraindicated in patients with:

• Autoimmune hepatitis.
• Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment.
• Hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment.

WARNINGS AND PRECAUTIONS

Treatment with RIBASPHERE (ribavirin, USP) and peginterferon alfa-2a should be administered under the guidance of a qualified physician and may lead to moderate to severe adverse experiences requiring dose reduction, temporary dose cessation or discontinuation of therapy.

Ribasphere (ribavirin, USP) must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection.

Ribasphere (ribavirin, USP) and peginterferon alfa-2a should be discontinued in patients who develop evidence of hepatic decompensation during treatment.

There are significant adverse events caused by ribavirin/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, ophthalmologic disorders, cerebrovascular disorders, pulmonary dysfunction, colitis, pancreatitis, and diabetes. The peginterferon alfa-2a package insert and medication guide should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

Pregnancy: Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients.

Anemia: The primary toxicity of ribavirin is hemolytic anemia (hemoglobin <10 g/dL), which was observed in approximately 13% of all ribavirin and peginterferon alfa-2a treated patients in clinical trials.

Hepatic Failure: Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including peginterferon alfa-2a. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART.

Hypersensitivity: Severe acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, and anaphylaxis) have been observed during alpha interferon and ribavirin therapy.

Renal Impairment: Ribasphere (ribavirin, USP) should not be used in patients with creatinine clearance <50 mL/min.

Pulmonary: Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, pneumonia, and occasional cases of fatal pneumonia, have been reported during therapy with ribavirin and interferon. In addition, sarcoidosis or the exacerbation of sarcoidosis has been reported.

Bone Marrow Suppression: Pancytopenia (marked decreases in RBCs, neutrophils and platelets) and bone marrow suppression have been reported in the literature to occur within 3 to 7 weeks after the concomitant administration of pegylated interferon/ribavirin and azathioprine.

Pancreatitis: Ribasphere (ribavirin, USP) and peginterferon alfa-2a therapy should be suspended in patients with signs and symptoms of pancreatitis, and discontinued in patients with confirmed pancreatitis.

Laboratory Tests: Before beginning peginterferon alfa-2a/Ribasphere (ribavirin, USP) combination therapy, standard hematological and biochemical laboratory tests are recommended for all patients.

Drug Interactions: Nucleoside Analogues: NRTIs: In clinical trials, cases of hepatic decompensation (some fatal) were observed among the CHC/HIV coinfected cirrhotic patients receiving NRTIs. Patients receiving peginterferon alfa-2a/ribavirin and NRTIs should be closely monitored for treatment associated toxicities.

ADVERSE REACTIONS

Peginterferon alfa-2a in combination with ribavirin causes a broad variety of serious adverse reactions. The most common serious or life-threatening adverse reactions induced or aggravated by peginterferon alfa-2a and ribavirin include depression, suicide, relapse of drug abuse/overdose, and bacterial infections, each occurring at a frequency of <1%. Hepatic decompensation occurred in 2% of CHC/HIV patients. Nearly all patients in clinical trials experienced one or more adverse events.

For more information please see the Ribasphere RibaPak (ribavirin, USP) Tablets Full Prescribing Information. The peginterferon alfa-2a Package Insert should be reviewed in its entirety for additional safety information prior to initiation of combination treatment.

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