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.
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.