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What's New in Treatment Information?
Excerpts From Hotline Memos of April 2000
from the Information Department of Project Inform

May, 2000

Efavirenz Reduces Lopinavir Levels

Early results from an interaction study between lopinavir (ABT-378) and efavirenz (Sustiva) shows that efavirenz decreases lopinavir levels in blood overall by 20%. Perhaps more importantly, lopinavir trough levels* are decreased by 43%.

As a result of this interaction, the dose of lopinavir should be increased to four capsules (533mg and 133mg of ritonavir) instead of three capsules (400mg/100mg). The capsules contain both lopinavir and ritonavir.

*The trough level is the lowest drug level found in blood right before another dose is taken. This is usually considered the most important level because if drug levels are too low, the virus is able to mutate and become resistant to the drug.

Emitricitabine Study Put on Hold

A South African study involving emtricitabine (FTC, Coviracil) has been put on hold by the US Food and Drug Administration (FDA) and the South African equivalent of the FDA known as the Medicines Control Council.

The study known as FTC-302 began in August 1999. A total of 470 people have been enrolled, and the study is ongoing. Its design compares emtricitabine and lamivudine (3TC, Epivir), both being used in combination with d4T and nevirapine (Viramune). People with high viral loads (>100,000 copies/mL) are taking efavirenz (Sustiva) instead of nevirapine.

Media reports suggest that there have been five deaths among people taking nevirapine. However, details supplied by Boehringer Ingelheim, the developers of nevirapine, suggest that only two of them are attributed to the drug. They have seen an 8.4% overall rate of grade III/IV (serious) elevations in liver enzymes and/or drug-induced hepatitis. One striking finding is the male to female ratio for this side effect is 1:2. The overall rate of drug-induced hepatitis is 1.8% and 6.9% for grade 3 or 4 elevations in liver enzymes.

One of these two deaths clearly looks like it's related to nevirapine, where the woman was co-infected with hepatitis B (HBV), but did not have detectable HBV levels at the start of the study. A month after starting nevirapine, she developed hepatitis and died.

The other death attributed to nevirapine was a woman who was assaulted and kicked in the stomach. She had been on nevirapine for a period of time. While she was hospitalized, a liver panel test was run and everything came back normal. However, a few days later she developed hepatitis and died from respiratory illness. The other three deaths were due to meningitis, pancreatitis and central nervous system deterioration.

Another ongoing study (any anti-HIV therapy with or without nevirapine) sponsored by Boehringer Ingelheim is known as BIPI 1090. It's a study to determine if adding nevirapine can delay development of opportunistic infections and/or death. It involves over 1,000 people per arm. There is a 9% rate for grade 3 or 4 elevations in liver enzymes (7.9% in the placebo group) and 1.2% have developed hepatitis (0.8% in the placebo group).

The rates of elevations in liver enzymes and hepatitis in FTC-302 are very similar to those seen in other nevirapine studies. One caveat to all of this is that a healthy volunteer study involving women conducted about eight years ago showed that the women had significant increases in liver enzymes. However, this has not been seen in any other study involving nevirapine and so it was thought to be a fluke. They are now looking at the BIPI 1090 study to see whether there's a difference in liver enzymes between men and women.

What is Armenicum?

Armenicum is an anti-HIV therapy currently being studied in Armenia and other countries from the former Soviet Union. The product is supposed to have been developed as part of an anti-germ/chemical warfare inoculation for Soviet troops. After the breakup of the Soviet Union, the Armenian facility that developed the inoculations fell into disuse, and its "products" became the property of the Armenian government. Armenicum was one of these products. At some point, the antiviral properties of Armenicum were "discovered." However, there is no data available to suggest any in vitro or in vivo anti-HIV activity.

Anecdotal information reports that several Americans have taken this therapy including two men from San Francisco. The dosing regimen was similar to that of IL-2. The product was given by infusion for several hours each day for five days. Then after a three-week interruption, the process was repeated three more times. The reported side effects were similar to those reported for IL-2 therapy: fever, chills, aching and fatigue. At latest report, the two San Francisco men have had no positive response to therapy.

Public Health Department Issues Warning about Herbal Supplements

The California Department of Public Health has issued the following warning about the use of a variety of herbal products. The warning is in reference to products which claim to contain only natural ingredients, but which contain prescription drugs used to treat diabetes. The California Food and Drug Branch (FDB), which is a state equivalent to the U.S. Food and Drug Administration (FDA), investigated a variety of products claiming to be herbal products after a patient with diabetes was hospitalized following use of one such product.


SACRAMENTO - Consumers should immediately stop using five herbal products because they contain two prescription drugs not listed as ingredients that are unsafe without monitoring by a physician, State Health Director Diana Bontá, R.N., Dr. P.H., said today. The products are Diabetes Hypoglucose Capsules, Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Hypoglycemic Capsules and Zhen Qi Capsules.

The products claim to contain only natural Chinese herbal ingredients. However, an investigation by the California Department of Health Services' Food and Drug Branch determined they contain the prescription drugs glyburide and phenformin, which can be used to treat diabetes.

The investigation was launched after a diabetic patient in Northern California suffered from several episodes of low blood sugar after consuming one of the products, Diabetes Hypoglucose Capsules. The patient has fully recovered.

Consumers should stop using these products and seek medical advice, especially if they are currently being treated with other anti-diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating or numbness of extremities. Consumers who use these products can receive a dangerously high amount of glyburide and phenformin.

These products are available from mail order and can be purchased by telephone or via the Internet:

Consumers should return these products to the seller or dispose of them safely to prevent exposure to children. The Food and Drug Branch is working closely with the U.S. Food and Drug Administration to stop importation of the products into the United States and remove them from sale.

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