Hepatitis & HIV

US approves Pegasys with ribavirin for chronic HCV in HIV/HCV coinfected adults; adds NRTI warning

Edwin J. Bernard
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The US Food and Drug Administration (FDA) announced yesterday that on February 25th it approved the combination of Roche’s Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) for the treatment of hepatitis C virus in HIV-positive individuals. The US announcement follows a similar approval by the European Commission on February 8th.

This extends the therapeutic options for adults chronically coinfected with HIV and hepatitis C virus. If they have clinically stable HIV disease (either on stable HIV antiretroviral therapy, or those who have not met the criteria to begin therapy) they can now take pegylated interferon alone, or in combination with ribavirin.

The recommended dose for the combination is 180µg pegylated interferon injected subcutaneously once a week and ribavirin 800mg by mouth daily given in two divided doses for a total of 48 weeks, regardless of genotype. Patients are advised to take ribavirin with food since this increases ribavirin absorption.

Glossary

pegylated interferon

Pegylated interferon, also known as peginterferon, is a chemically modified form of the standard interferon, sometimes used to treat hepatitis B and C. The difference between interferon and peginterferon is the PEG, which stands for a molecule called polyethylene glycol. The PEG does nothing to fight the virus. But by attaching it to the interferon (which does fight the virus), the interferon will stay in the blood much longer. 

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

cirrhosis

Severe fibrosis, or scarring of organs. The structure of the organs is altered, and their function diminished. The term cirrhosis is often used in relation to the liver. 

hepatic

To do with the liver.

monotherapy

Taking a drug on its own, rather than in combination with other drugs.

The FDA has added a warning to the label information regarding the increased risk of liver failure in patients with cirrhosis on anti-HIV therapy and pegylated interferon, based on data from the APRICOT study. The study found that amongst 129 HIV/hepatitis C virus coinfected patients with cirrhosis taking both anti-HIV therapy and Pegasys, 14 (11%) developed hepatic decompensation, resulting in six deaths. All 14 were taking nucleoside reverse transcriptase inhibitors (NRTIs), including stavudine (d4T, Zerit), didanosine (ddI, Videx EC), abacavir (Ziagen), zidovudine (AZT, Retrovir) and lamivudine (3TC, Epivir). Due to the small numbers involved, it is not possible to narrow down which NRTIs may increase the risk, and so the FDA included a recommendation that all patients on NRTIs and Pegasys be closely monitored for treatment-associated toxicities.

Both the US and EU approvals were based on the final results of the APRICOT study, which found that overall, 40% of individuals coinfected with HIV and hepatitis C virus and treated with pegylated interferon and ribavirin achieved a sustained virological response after the completion of therapy, compared to 20% of individuals who received pegylated interferon monotherapy and 12% of patients who received standard interferon and ribavirin.

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