(RITA!) HIV Treatment Alerts - April 2002

FDA Bits

• The Food and Drug Administration (FDA) has approved an official recommended dose for combining the protease inhibitors amprenavir (Agenerase) and ritonavir (Norvir). When the two are used in combination, 1200 mg of Agenerase can be given with 200 mg of Norvir once a day, or 600 mg of Agenerase can be given with 100 mg of Norvir twice a day. The small amount of Norvir is used as a "boost" to increase the levels of Agenerase in the blood. In the case of Agenerase, which is one of the largest anti-HIV pills, this combination also helps reduce the number of pills needed.
• The FDA has approved a new version of the anti-HIV drug efavirenz (Sustiva). The new 600 mg tablet will replace the three 200-mg tablets that are usually required once a day. The new tablet reduces the number of pills needed, which is a small step toward making anti-HIV medication easier to take. However, the 200-mg tablets will still be available for people who prefer them.
• Add the dietary supplement kava to your list of herbs to watch out for: a recent FDA bulletin warns that the herb (sometimes called "kava kava" or "Piper methysticum") may be toxic to the liver. Kava can be found as a supplement by itself, or as an ingredient in some herbal blends. Twenty-five cases of liver disease associated with the use of kava extracts have been reported in Germany and Switzerland. The FDA is investigating to see if there is a similar—but unrecognized—problem in the US. Kava is supposed to help relieve stress, insomnia, and even premenstrual syndrome (PMS).

Bad to worse? Last issue's "Treatment News" (see HIV Treatment ALERTS! November 2001: www.aegis.org/pubs/rita/2001) described a possible side effect of NRTI drugs: muscle weakness as a sign of lactic acidosis. Bristol-Myers Squibb, the company that makes ddI (Videx) and d4T (Zerit) issued a special notice to doctors. Earlier this year, a drug warning was issued to doctors by the company's Vice-President for Medical Affairs, Virology. The warning basically says that if muscle weakness develops in someone taking d4T, the drug should be stopped immediately. Some cases have been fatal. Studies show that lactic acidosis may be more common when anti-HIV drug combinations contain d4T. However, it is important to remember that anyone experiencing lactic acidosis should stop taking all anti-HIV medications. Other symptoms of lactic acidosis include nausea, diarrhea, sudden weight loss, abdominal pain, rapid breathing, muscle pain or cramps, general fatigue, and feelings of tingling or pricking of the skin. Currently, regular measurements of lactic acid levels in the blood are not recommended.

Lift! Weight training (sometimes called "resistance training") can be an important component to an exercise program, as shown by a recent study published in Medicine & Science in Sports & Exercise (2001 Nov;33(11):1811-7). In the study, researchers at Tufts University in Massachusetts worked with HIV-infected men and women for 16 weeks to see the effects of increasing strength and lean body mass (muscle) on health. Six of the men were experiencing AIDS wasting (meaning they lost 10% or more of their body weight in the previous year). Exercise included leg presses, leg extensions, chest presses, and rowing, and was meant to work large muscle groups. The study participants reported whether or not their physical performance had improved. The patients with wasting reported significant improvements, which were predicted by measured improvements in lean body mass and strength ability. The researchers plan other studies to find out the best strength-training methods for people with HIV.

Kidney failure in women with HIV. A study published in the journal Kidney International (2002 Jan;61(1):195-202) points to some factors that could predict kidney failure in women with HIV. The study looked at more than 2000 HIV-positive women and found that roughly one third of the women had elevated levels of protein in their urine. This condition is called "proteinuria" and indicates problems with kidney function. Kidneys help take waste products out of the body and bring them to the bladder for excretion as urine. Risk factors that predicted proteinuria in the women were: Black race, being positive for hepatitis C, and T cells at 200 or less. Also, the risk of proteinuria increased with HIV viral load (for instance a viral load of 400,000 showed a 5% greater risk than a viral load of 40,000). Other signs predicting kidney problems included rising systolic blood pressure, falling albumen levels, and increasing creatinine levels. (These are all usually measured in HIV-positive patients during a routine check-up). The researchers suggest that some of the damage may be caused by direct infection of the kidneys by HIV. Better control of HIV viral load and improved T cell counts may help reduce the risk and progression of kidney disease in HIV-infected people.

Cancer concerns

• A review of medical records of patients with HIV shows that bacterial pneumonia and a cancer known as non-Hodgkin's lymphoma (NHL) are now more common than back in 1993 to 1995. These years were during a time before combination anti-HIV therapy was being used. The main lung disease back then was PCP, a type of opportunistic infection, which is now much less common. Researchers suggest that the risk of NHL may be greater in patients who have experienced more advanced HIV disease, such as very low T cell counts, before receiving potent anti-HIV therapy. The research is published in the journal Chest (2001 Dec;120(6):1888-93). The main concern is that health care providers be aware of NHL symptoms (like unexplained fever or weight loss) and realize that people with HIV are at greater risk.
• According to a report in the International Journal of Cancer (2001 Dec 1;94(5):753-7) women with HIV are at greater risk of cancer than uninfected women. Over 1300 women were studied from 1993 through 2000. The HIV-infected group had 26 cancers (including 4 cases of lung cancer), while the uninfected group had 4 cancers (including 1 lung cancer). Even though both groups had similar histories of tobacco smoking, the women with HIV had twice the risk of getting lung cancer. Also, the HIV-infected women with lung cancer were young (average age of 40) and died within 6 months of diagnosis. This suggests that such cancers are more aggressive in HIV-infected women. Other cancers that were seen in the HIV-infected group were invasive cervical cancer and NHL.
• Finally, a recent study (The Lancet, 2002 Jan 12;359(9301):108-13) found precancerous genital lesions and growths in 6% of 481 HIV-infected women, versus 1% of 437 HIV-negative women. The researchers recommend thorough gynecological examinations in women with HIV because of a potential increased risk of invasive cancer of the vulva.

Lactic acidosis: accumulation of lactic acid in the body. Lactic acid is a substance in blood and muscle tissue produced by the body when it is processing sugar for energy (usually when exercising or in the absence of normal levels of oxygen)..

Opportunistic infection: a disease caused by an organism that is usually harmless, but becomes activated when a person's immune system is impaired or damaged.

Toxic: being poisonous or damaging to the body.

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Copyright © 2002 - Research Initiative Treatment Action (RITA!). Reproduced with permission. RITA! is published by The Center for AIDS. Contact Thomas Gegeny, MS, ELS, Editor, RITA! for permission to reproduce RITA!. tom@centerforaids.org. http://www.centerforaids.org

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