(RITA!)HIV Treatment Alerts - February 2001
 

Did you know?
Liver failure is on the rise. A study reported in the journal Clinical Infectious Diseases (32, p. 492, 2001) indicates that more and more HIV infected patients are dying from liver disease. The increase in death from this cause may be explained by the fact that liver disease may be accelerated in patients with both hepatitis C and HIV. In the study, the researchers looked at the causes of death for patients at the Lemuel Shattuck Hospital in Massachusetts during 3 time periods.

• In 1991 only 11.5% of patients died from liver disease;
• In 1996 (after drug "cocktails" were introduced) the rate of death from liver disease was 13.9%;
• From 1998 to 1999 liver disease accounted for 50% of the deaths.

The researchers conclude that patients should be screened on their first visit for both HIV and hepatitis C. When appropriate, patients should receive vaccines for other forms of hepatitis or have liver biopsies. There is no cure or vaccine for hepatitis C.

Early access update. Tenofovir is a new anti-HIV drug being developed by Gilead Sciences. As of February 2001 the company is offering the drug through a special program to patients who

• Have a viral load equal to, or greater than 10,000 copies;
• Have a T cell count equal to, or less than 100 cells; and
• Have failed at least 2 protease inhibitors or 1 protease inhibitor and a non-nucleoside reverse transcriptase inhibitor (i.e. Sustiva, Rescriptor, or Viramune).

It is also being offered to patients who have T cell counts of 100 to 200 and have had an AIDS-defining opportunistic infection in the last 90 days. If you qualify, talk to your doctor about this new drug. To enroll patients in the program and receive drugs, doctors should call 800.GILEAD-5.

Directions in treatment. Since 1996, a panel of US experts has recommended that people with HIV take anti-HIV medicines if their T cell counts are below 500. While antiviral drugs work wonders for people with very low counts (for example, less than 100), there's no proof that people with higher numbers benefit from the drugs. Now, with drug toxicities and treatment fatigue on the rise, the US experts are backing off. Their new recommendations are that therapy be delayed until the T cell count is less than 350 or the viral load is greater than 55,000 copies. For more than a year now, The Center for AIDS has supported a start-to-treat trigger of 250 cells, and we're delighted the experts are moving in that direction. Their new recommendations mean that potentially thousands of patients will be spared the side effects and inconvenience of early treatment. Also, this approach could save millions of dollars in health care costs. The updated guidelines are available online at www.hivatis.org.

Warning for pregnant women. Three cases of fatal lactic acidosis, as well as several other nonfatal cases, in pregnant women have prompted a new drug warning about the use of the anti-HIV drugs stavudine (Zerit or d4T) and didanosine (Videx or ddI) in combination. These cases occurred with or without pancreatitis. Early this year, Bristol Myers Squibb (the company that makes both drugs) sent an alert to health care professionals about the potential increased risk of lactic acidosis and liver damage in pregnant women treated with d4T and ddI. The drugs should only be used by pregnant women in situations where the benefits outweigh the risks. Only a health care provider experienced in treating HIV should make such a decision. The US Food and Drug Administration (FDA) will include this warning in both drugs' prescribing information. Also, the FDA encourages healthcare providers to report any additional adverse events (800.FDA.1088).

Nevirapine rash: worse in women. Nevirapine (Viramune) is a member of a family of anti-HIV drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). The most common and potentially serious side effect of nevirapine is a skin rash that usually develops within 6 weeks of starting the drug. A 14-day lead-in period, in which the drug is given only once a day at 200 mg, is recommended to reduce the incidence of the skin rash. Now, a study in the journal Clinical Infectious Diseases (32, p. 124, 2001) has found that women are almost 7 times more likely than men to develop severe rash. This study is based on a review of the medical records of 358 patients (27% female, 73% male) who had taken nevirapine. The research also found that people with T cell counts greater than 200 (at the time they started nevirapine) were more likely to develop severe rash than people with less than 200 cells. It is important to remember that the use of prednisone is not recommended to treat the rash. Prednisone actually increases both the occurrence and severity of nevirapine-related rashes and should not be used. For complete safety information on nevirapine, ask your doctor or pharmacist, or visit www.viramune.com.

DEFINITIONS

Adverse: harmful or unfavorable.

Lactic acidosis: accumulation of lactic acid in the body.

Pancreatitis: inflammation of the pancreas, an internal organ, usually involving pain in the upper abdomen (just under the ribs) and possible nausea and vomiting.

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Copyright © 2001 - 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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