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.
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.
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.
STATE HEALTH DIRECTOR WARNS CONSUMERS ABOUT PRESCRIPTION DRUGS IN HERBAL PRODUCTS
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:
- Diabetes Hypoglucose Capsules are sold by Chinese Angel Health Products Inc., also known as Chinese Herbal Health Products, 2118 Wilshire Blvd, P.O. Box 498, Santa Monica CA 90403. These capsules, which are green and white, are available in 70-capsule bottles. The label has green and black English printing with a picture of a plant. The UPC number is 6-923174-911016.
- Pearl Hypoglycemic Capsules, imported by Sino American Health Product Inc., 2421 W. 205th St., Suite D103, Torrance CA 90501, are sold by the importer and Chinese Angel Health Products Inc. Chinese Angel Health Products also relabels the product. Capsules, available in 60-capsule bottles, are blue and white with Chinese characters imprinted on one side of the capsule. The red, green and black English label is placed over the Chinese manufacturer's label that contains black and green Chinese characters and a red logo.
- Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules and Tongyi Tang Diabetes Angel Hypoglycemic Capsules are available in 60-capsule bottles. The capsules are blue and white with Chinese characters imprinted on one side of the capsule. The label has red, green and black English printing and Chinese characters. The UPC number is 6-920555-319966.
- The Zhen Qi Capsules are available in 60-capsule bottles. The capsules are clear. The green label has silver English printing with a picture of a leaf. The product is manufactured for Sino American Health Products Inc. of Torrance CA 90501. The UPC number is 7-63052-31148.
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.