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What's New in Treatment Information?

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

March 2001

Peg-Interferon-Alfa Approved for Hepatitis C

The Food and Drug Administration (FDA) recently approved peg-interferon-alfa (Peg-Intron) for treating hepatitis C virus (HCV). This new formulation is bound to a chemical called polyethylene glycol, which makes the drug stay in the blood stream for longer periods than standard interferon-alfa.

The FDA approved using peg-interferon alone and not in combination with ribavirin (Rebetol). One large study showed that the new formulation was about twice as effective in controlling HCV replication compared to the standard formulation (24% vs. 12% of the participants had HCV RNA levels below 100 copies after 72 weeks). However, more people taking peg-interferon developed mild bone marrow suppression.

The results of using peg-interferon alone are comparable to those seen with standard HCV therapy, which is a combination of standard interferon-alfa and ribavirin (bundled as Rebetron). However, more recent results suggest that combining peg-interferon with ribavirin will be more effective. Through injection under the skin, peg-interferon-alfa is dosed only once a week while standard interferon-alfa is dosed three times a week.

Schering-Plough, the developers of Peg-Intron, recently unbundled ribavirin from regular interferon, something that the activist community has demanded for the past two years. So it is now possible for people to buy ribavirin separately and use it together with other interferon-alfa products or anti-HCV therapies. The cost of peg-interferon will be about twice that of standard interferon ($1,200 vs. $600 per month).


Amprenavir Oral Solution Warning

A warning has been issued regarding the use of the oral solution of amprenavir (Agenerase). This warning does not apply to the capsule form of the drug.

The oral solution, primarily used with children, may cause more side effects than the pill form because it contains a large amount of the substance, propylene glycol. This substance is used to increase the absorption of the drug.

As a result, amprenavir oral solution should not be used by children under the age of four, pregnant women, people with liver or kidney failure and people taking disulfiram (Antabuse) or metronidazole (Flagyl). Additionally, certain racial groups, Asians, Eskimos and Native Americans, may be more likely to develop propylene glycol-related side effects because of genetic differences that impact the way the body breaks down and processes the chemical. People should also avoid drinking alcohol if they take the oral solution.

It is unclear, however, whether many adults are using the liquid solution. People taking amprenavir oral solution should be closely monitored for propylene glycol-related side effects, including seizures, stupor (mental numbness), increased heart rate, increased lactate levels (lactic acidosis), kidney side effects and destruction of red blood cells (hemolysis).

A serious concern about this warning is that it may have the effect of greatly limiting the use of amprenavir in children. While children can in theory be switched to the pill form, the currently available pills are large and difficult to take, even for adults.

HIV-associated Wasting Studies Provide New Results

Recently released results show that adding testosterone to megesterol acetate (Megace) does not result in additional weight gain. Earlier studies showed that almost all the weight gained from using Megace is due to fat gain and not lean body mass gain. Researchers believed this was due to Megace causing hypogonadism and so reducing the increase in lean body mass.

In the study, 81 people with HIV-associated wasting disease used either Megace alone (800mg a day) or together with testosterone (200mg twice a week for men and 100mg twice a week for women by injection into muscle). After 12 weeks, people taking Megace alone gained an average of 7.3kg (about 16 pounds) compared to only 5.3kg (almost 12 pounds) for those on the combination. Both groups increased their lean body mass by an average of 3.3kg (about 7 pounds). Not unexpectedly, people taking testosterone had greater sexual drive and function.

A study of nandrolone (Deca-Durabolin) shows that women taking the drug had increased weight and lean body mass. The study followed 38 women with HIV-associated wasting disease. They used 100mg of nandrolone twice a week by injection into the muscle or placebo for twelve weeks. After the first twelve weeks, everybody took the drug for another twelve weeks.

Results after twelve weeks showed that women who used nandrolone gained an average of 4.6kg (about 10 pounds) in weight and 3.5kg (almost 8 pounds) in lean body mass while those taking the placebo had no significant changes in either measurement. Some women taking nandrolone experienced virulizing effects such as hoarseness, excessive hair growth and clitoral enlargement, though these effects were rare.

ddI Warning

Results from a new study suggest that once a day dosing of ddI may not be as effective as twice a day dosing. Moreover, the combination of once a day ddI (400mg) with d4T and nelfinavir (Viracept) was found to be less effective than AZT + 3TC + nelfinavir. Earlier studies have shown similar effectiveness between these two combinations when ddI was taken twice a day.

This new study enrolled 756 people who had not taken anti-HIV therapies before. Twice as many volunteers used d4T + ddI as those who used received AZT + 3TC. After 24 weeks, there were no differences between the two groups and, as a result, the once a day dosing of ddI was approved. However, after 48 weeks of the study, there was a significant difference in anti-HIV activity between the two groups. The results after 48 weeks are as follows:

% <400 copies
% <50 copies
d4T + ddI + nelfinavir
AZT + 3TC + nelfinavir

As a result of this finding, people are recommended to take ddI twice a day rather than once a day. There are a couple of possible reasons for this discrepancy. Twenty-one people (4%) who were supposed to take d4T + ddI + nelfinavir did not start therapy compared to five people on 3TC (2%). Additionally, 20 people (8%) switched from AZT to d4T compared to 16 people (3%) who switched from d4T to AZT. Most of the AZT to d4T switched occurred during the first 24 weeks of the study whereas most of the d4T to AZT switched after the first 24 weeks.

Back to the What's New? March 2001 Table of Contents.

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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.