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What's New in Treatment Information?

Excerpts From Hotline Memos of June 2001
from the Information Department of Project Inform

July 2001

Beware of Counterfeit Products

Recently there have been reports of two counterfeit drug products. One is a counterfeit human growth hormone (rHGH, Serostim) and the other is counterfeit filgrastim (Neupogen). People with HIV commonly use both. Growth hormone is used to treat HIV-associated wasting disease and is now being explored to treat fat accumulation due to lipodystrophy syndrome(s). Filgrastim is used to raise neutrophils, a type of white blood cells, which are important in protecting the body from infections.

Counterfeit rHGH carries a lot number MNH605A. Any product with this number should be considered counterfeit and should not be used. The FDA reports the counterfeit product contains only 1/6 of the dose of rHGH. Previous reports of counterfeit rHGH revealed the old lot number to contain human chorionic gonadotropin (HCG) instead of rHGH. HCG has some anabolic affects and is being researched for its anti-HIV and anti-KS potentials. That counterfeit rHGH is still being analyzed for other contaminants. For more information, call Serono, the manufacturers of rHGH, at 1-888-275-7376.

Counterfeit filgrastim has a lot number of P000948 or P000890 and expiration date of 12/02. Further, the packet insert is on regular stock paper -- not on thin, lightweight paper. For more information, contact Amgen, the manufacturers, at 1-800-772-6436 or http://www.amgen.com/corporate/AmgenNews.html.

If you suspect you have counterfeit product, return it to the pharmacy where you purchased it for a replacement.

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New Peg-Interferon Results

Encouraging results of the pegylated interferon products to treat hepatitis C virus (HCV) were recently presented. The studies show that this new formulation, when used together with ribavirin (Rebetol) is more effective in treating HCV than the standard regimen of regular interferon-alfa combined with ribavirin (Rebetron).

One study showed that about 35% of people who did not benefit from standard Rebetron as first line therapy achieved a reduction in HCV RNA levels with the combination of peg-interferon alfa-2b (peg-Intron) and ribavirin after 24 weeks. Although the early results are encouraging, the usefulness of this combination as second line therapy will not be known until the study is completed.

Another study showed 61% of the participants, who had not used anti-HCV therapy before, had a sustained virologic response after 72 weeks of the peg Intron/ribavirin study. Specifically, 48% with geno-type 1 (the most difficult type of HCV to treat) and 88% with genotypes 2 or 3 had a sustained response. The dose of peg-Intron was 1.5mcg/kg once a week with at least 10.6mg/kg of ribavirin daily.

Peg-Intron is approved by the Food and Drug Administration to treat HCV when used alone, but not together with ribavirin. However, the result from the second study support using the combination, for which it is likely to be approved soon.

Results from a study of a different pegylated interferon (Pegasys) are also encouraging. This study included 1,121 people who have not taken anti-HCV therapy before and used the standard Rebetron, Pegasys alone or Pegasys in combination with ribavirin. The dose of Pegasys was 180mcg once a week and the dose of ribavirin was 1,000-1,200mg daily. At the end of 72 weeks, the percentage of people with HCV levels below 50 copies/mL were:


 Pegasys aloneRebetronPegasys + ribavirin
Overall Response30%45%56%
Response for genotype 121%37%46%
Response for genotype 2 or 345%61%76%


Further analysis found that people who did not have a response by week 12 were highly unlikely to achieve undetectable HCV levels by study end. Also, people who were over 80% adherent to their meds were much more likely to achieve undetectable levels by study end. Side effects overall were similar among the three groups, although there appeared to be less severe flu-like symptoms and depression among people taking Pegasys and ribavirin than those on Rebetron.




  
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This article was provided by Project Inform. It is a part of the publication What's New. Visit Project Inform's website to find out more about their activities, publications and services.
 
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