Nevirapine alert sounded again, in Europe

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Nevirapine alert sounded again, in Europe

The Washington Blade - April 21, 2000
Lisa Keen


For at least the second time in two years, experts are warning doctors to carefully monitor their patients with HIV who are taking the non-nucleoside antiviral nevirapine, particularly in the first two months of taking the drug. The statement also urged that patients with a history of skin and liver complaints, such as hepatitis, should not take the drug.

The European Agency for the Evaluation of Medicinal Products issued its warning on April 11. According to Reuters wire service, the agency's statement said the warning was being issued in response to additional reports of patients suffering from severe liver and skin reactions, acute kidney failure, hepatitis, fever, rash, painful joints and muscles, some of which were potentially fatal. The statement did not specify how many patients suffered such reactions, but Reuters said the agency alert indicated, "Some of the severe cutaneous reactions were associated with risk factors such as not following the dose escalation regimen or delaying seeking medical attention when the symptoms appeared."

In 1998, researchers at the Medical College of Wisconsin said they observed the reaction in one patient and had found reports of similar dangerous side effects in at least 19 others since 1997 when nevirapine hit the market.

Nevirapine is marketed as Viramune by Boehringer Ingelheim.

Herpes alert: More people need worry

A report published last month suggested that many people have genital herpes and are spreading it because they don't recognize the symptoms or, in many cases, don't have the symptoms, but are still capable of infecting their sex partners. According to the report, in the March 23 issue of the New England Journal of Medicine, about one in every four people in the United States is infected with the herpes simplex virus-2 (HSV-2), but only about 25 percent of these infected people develop the genital lesions that they can readily recognize. While previously, doctors believed that only symptomatic patients could spread the virus, more recent research is indicating that even the asymptomatic can spread it.

"Historically, it has been assumed that persons with asymptomatic HSV infections have less frequent and less severe reactivations [of viral replication] than those with symptomatic disease," noted the authors of the report, a team of nine doctors from laboratories in Seattle, and Portland, Ore. "However, two lines of evidence suggest this may not be true."

The doctors studied 53 patients who had antibodies to HSV-2 in their blood but who said they had seen no lesions associated with the infection. The symptoms of genital herpes include blister and ulcer-like lesions on the genitalia, as well as fissures, itching, and tingling.

HSV-2 is typically associated with a genital herpes infection, while HSV-1 is usually associated with cold sores on the lips. Either virus, however, can cause an infection in either the mouth or genital area.

The researchers asked this group of people to take daily swabs of their genital mucosa for 90 days. They also gave them an educational presentation to help them identify any symptoms. After taking that course, 87 percent reported that they had, in fact, experienced symptoms. And 83 percent showed signs of viral "shedding" -- or the release of virus into their genital mucosa fluids. Virus was isolated from their genital mucosa 3.8 percent of the days, compared to 6 percent cultured from the mucosa of patients who had HSV-2 and noticeable symptoms. It is during these times of "viral shedding" that an infected person can transmit the virus to another person.

"At present, the medical and public health communities largely ignore persons who have asymptomatic HSV-2 infection," noted the authors of the paper, "because little information is available regarding the benefit of identifying such persons.

"...However, the rates of subclinical viral shedding were similar among the subjects with previously unrecognized genital herpes and those with recognized infection. ...Our findings concerning the potential for the transmission of HSV to sexual partners are therefore not comforting to either patients or [health care] providers."

Laboratory tests have recently become available commercially, noted the doctors, making it "possible to identify the large reservoir of persons with infrequent, short episodes of" viral shedding.

In brief ...

FREE NEWSLETTER: The National Prostate Cancer Coalition announced this week that it is launching a free e-mail newsletter to provide news on prostrate cancer twice a week. To register for the newsletter, called SmartBrief, go to the NPCC's Web site at www.npcc.org.

WHITMAN-WALKER CHAT: The Whitman-Walker Clinic's online chat group on AIDS-related topics visits the cyberSTOP Caf , 1513 17th Street, NW, from 7:30 to 8:30 p.m. this Tuesday, April 25. The caf is providing free Internet access and refreshments. For more information, log on to the Clinic's Web site at www.wwc.org.
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