October 2001

Physicians report on HIV ‘superinfection’

GENEVA — Researchers have reported that a 38-year-old man acquired a second subtype of HIV through unprotected sex more than two years after he was first infected.

The research team documented the case because the patient was enrolled in an AIDS drug study to test treatment of the virus. The study researchers reported their findings recently in The New England Journal of Medicine. (2002; 347:731-736).

The man was successfully treated for more than two years and was taken off the drugs after getting an experimental vaccine intended to bolster his immune system. A few months later, and weeks after he had unprotected sex in Brazil, his virus level jumped. He was found to be infected with a different strain that was endemic in Brazil.

The patient then resumed medication and has responded well, but the research team cautioned that the patient makes a strong case for practicing safe sex, even among partners who are already both infected.

Roche’s viral load test approved by FDA

ROCKVILLE, Md. — The FDA has given marketing approval to Roche Diagnostics for the Amplicor, HIV-1 Monitor test, version 1.5.

This test is a highly sensitive laboratory test to measure levels of HIV circulating in an infected person’s blood. The test can measure HIV-1 RNA over the range of 50-750,000 copies/ml and detect Group M subtypes A-G of the virus.

“This is a significant achievement for HIV-1 treatment. Research has shown us the importance of measuring viral load levels to as low a level as possible,” said William Valenti, MD, an AIDS-treating physician and researcher, founding medical director of Community Health Network, and associate professor of Medicine at Rochester University School of Medicine, Rochester, NY.

Measuring viral load level is an important part of assessing a patient’s disease prognosis and response to drug therapy, enabling the physician and patient to make informed treatment choices and to help achieve an optimal positive response to therapy. Studies indicate that lowering plasma HIV RNA below 50 copies/ml is a strong indicator of viral suppression.

“With a specificity of 100% and a sensitivity down to 50 copies/ml, clinicians and patients can be confident of being able to detect a broad range of subtypes, and thus gain an accurate picture of their disease,” explained Tadd Lazarus, MD, director of medical affairs for Roche Diagnostics, an HIV primary care internist at St. Vincent’s Hospital in New York City and assistant professor of clinical medicine at New York Medical College.

Researchers have identified several subtypes of HIV-1. These subtypes are considered to be mutations of the virus and prevalence is varied by geography across the continents and various regions.

Subtype B is the most prevalent in the U.S., Europe, South America and Australia, though there has been an increasing prevalence of other subtypes in some of these areas, including the United States. The Indian subcontinent and parts of Asia report a wider variety of subtypes, while Africa has the most diverse prevalence. Research also suggests that certain subtypes may be associated with specific modes of HIV transmission.

Bayer’s viral load test approved by FDA

ROCKVILLE, Md. — The FDA has granted marketing approval to Bayer Diagnostics for Versant HIV-1 RNA 3.0 Assay (bDNA), its nucleic acid probe diagnostic assay for the direct quantification of HIV-1 RNA in the plasma of people living with HIV.

According to Bayer officials, the assay is the first to “reliably detect significant changes in viral load across the entire assay range.”

According to the assay’s manufacturer, it is the only FDA-approved test capable of reliably detecting significant (threefold and greater) changes in viral load throughout its entire quantification range.

The Bayer branched DNA (bDNA) viral load system is the first approved viral load test that automates critical assay steps and includes approved software for automatic results generation, reducing the possibility of human error associated with manual calculation of results.

The bDNA system also is able to detect and accurately quantify all major subtypes of HIV, Group M subtypes A-G. While the most common subtype in the United States is subtype B, the emergence of non-B subtypes has been reported.

“Bayer’s bDNA HIV viral load test is an essential tool for effective management of patients with HIV-1 infection,” said David Chernoff, MD, assistant professor of medicine, University of California at San Francisco and attending physician, San Francisco General Hospital. “This test accurately measures viral load, is highly reproducible and sensitive, and reliably measures the major HIV-1 subtypes (B and non-B), making this a critical assay for use worldwide.”

The level of HIV RNA in a patient’s blood has been shown to correlate with the progression of the disease and, for patients undergoing antiretroviral therapy, frequent monitoring of HIV RNA is recommended for determining the effectiveness of therapy and the emergence of drug resistance.

New members named to CDC’s HIV advisory committee

ATLANTA — HHS Secretary Tommy G. Thompson recently announced the appointment of six new members to the CDC’s Advisory Committee on HIV and STD Prevention.

The new Advisory Committee members are Beny J. Primm, MD, of Brooklyn, N.Y.; David James Farabee, MS, PhD, of Los Angeles; Antonia M. Villarruel, RN, PhD, of Ann Arbor, Mich.; Gale Elizabeth Grant, MA, PhD, of Richmond, Va.; Renee Cobos, MD, of Brea, Calif.; and Freda McKissic Bush, MD, FACOG, of Jackson, Miss.

The advisory committee meets two times per year and consists of 18 members who are knowledgeable in the fields of public health, epidemiology, laboratory practice, immunology, infectious diseases, drug abuse, behavioral science, and health education.

Primm is the executive director for Addiction Research and Treatment Corp., which provides a multi-modality service and treatment program for approximately 2,300 men and women who are primarily members of severely underserved populations. Primm was appointed to the Presidential Commission on the HIV epidemic in 1987 and was appointed to direct the Center for Substance Abuse Treatment in 1989. He also has served on special committees on drug and alcohol abuse for WHO and as a consultant to the Drug Abuse Policy Office of the White House.

Farabee is an associate research psychologist at the Neuropsychiatric Institute’s Drug Abuse Research Center at the University of California, Los Angeles. Farabee previously served at the University of Kentucky and as a lead researcher for the Texas Commission, Alcohol and Drug Abuse. In 2001, he served as co-editor of the Offender Substance Abuse Report, a bi-monthly publication published by the Civic Research Institute.

Villarruel is the director of the University of Michigan’s Center for Health Promotion. She serves as an associate professor at the University of Michigan and has served at the University of Pennsylvania. She is a member of the American Academy of Pediatrics, Child Health Research Center, and Latino Children’s Health Consortium, and she recently received the Distinguished Visiting Minority Scholar Award from the University of North Carolina’s School of Nursing. She also serves as vice-president of the National Coalition of Ethnic Minority Nursing Associations.

Grant is a program specialist for the Virginia Department of Health and directs the statewide abstinence education initiative. In 2001, she served as a Proposal Reviewer for the Health Resources and Services Administration’s Maternal and Child Health Bureau. She is a certified Prevention Professional, a member of the National Council of Family Relations, and has served on the Minority Health Advisory Board for the Richmond Public Health Department.

Cobos is a staff dermatologist at Kaiser Permanente in Brea, Calif. and serves as a professor in the at the University of California, Irvine. Before accepting that position in 1999, she was chief of dermatology for the Kaiser Permanente Medical Center in Baldwin Park, Calif. for eight years. Since 1996, Cobos has served in various capacities in the Dermatology Society of Orange County, most recently as president, 1998-1999. She is also the Director of the Dermatology Core Curriculum Committee Lecture Series for the Southern California Permanente Medical Group.

Bush is certified by the American Board of Obstetrics and Gynecology and is in private practice at East Lakeland OB-GYN Associates in Jackson, Miss. She serves as an instructor in both the department of obstetrics and gynecology and the department of family medicine at the University of Mississippi Medical Center. Bush is a Fellow of the American College of Obstetrics and Gynecology and a member of the American Medical Association. She also serves as the president of the Mississippi State Board of Medical Licensure.

— compiled by Colleen Zacharyczuk