July 9, 2001
My good friend Vicente Soriano presented this important preliminary report on pegylated interferon and ribavirin in co-infected patients. This is a burning problem often addressed at The Body's Hepatitis Forum. Hepatitis C is becoming the leading cause of death in many HIV centers and the treatments have not been satisfactory up until now, if they have been used at all.
This combination has been studied in HIV-negative persons and the results reported this year for both the Schering product (interferon alfa 2b, or Peg Intron) and the Roche product (interferon alfa 2a or Pegasys). The sustained virologic response rates (cure rates) for these products are way over 50% and approaching 60% for all patients.
This has not been studied yet in HIV patients. The pegylated version of interferon is able to be administered once weekly and also has some anti-HIV activity. Pegylation also reduces the side effects and increases the quality of life of the patients, making it much better tolerated. There are two large trials using the Roche alfa 2a (Pegasys) ongoing, one called APRICOT is an international trial with 741 patients expected to enter by August 2001. The ACTG trial 5071 had entered over 100 patients and is now closed.
This trial used the Schering product alfa 2b (Peg Intron) with 800mg per day of ribavirin. It was not randomized and all patients received the same regimen. This is a small proof-of-principle study enrolling 51 patients. 31 of the 51 had 24-week data and that is what was presented.
The inclusion criteria were strict in this trial, which is typical of Soriano's trials. Median CD4 count was 623, median HIV RNA was 6,280, indicating very good HIV control. 22/31 were male.
4/31 stopped therapy for adverse events in the 24 weeks, which is about the same number that would stop in an HIV negative trial. Ribavirin dose was decreased in two and discontinued in one patient. HCV RNA became undetectable in 20/31 (65%) and the liver enzymes ALT and AST became normal in 24/31 or 82%. There was no change in CD4 and HIV RNA actually decreased in two patients.
This is a very preliminary result that is quite promising. It does not show sustained rates yet, but it will in another year. Meanwhile, it does show that Peg Intron is well tolerated with ribavirin in HIV patients with hepatitis C and that the early hepatitis C results look great. They should be the same as in the HIV-negative patients when this trial is completed.
This is a small but encouraging step in successfully treating hepatitis C in HIV patients with pegylated (once weekly) interferon. The other trials looking at this are still in progress, and we have no data from them yet. However, I would expect a similar result. This is good news for all HIV patients with hepatitis C.
The FDA approved Peg Intron this past February and the combination with ribavirin is expected to be approved in August or September 2001. It is not being covered yet by Medicaid or ADAP, but it should be when the combination gets approved. The Roche peg is expecting approval in the fourth quarter of this year. The use of ribavirin with Pegasys is not yet worked out with the FDA to my knowledge. These two drugs should make treating hepatitis C in HIV much easier and more effective so that many patients who were waiting for something new should jump at this chance. The other drugs in development for hepatitis C are still at least five years away, so now is the time to consider therapy.
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