HIV Testing Blog

The US Court of Appeals for the Federal Circuit last week ruled in favor of Roche in a longstanding patent-infringement dispute with Stanford University regarding ownership of PCR-based test kits for measuring HIV viral load.

Stanford did not have standing to file suit because, the court determined, Roche owned the patents at issue.

A lower court, the US District Court for the Northern District of California, was instructed to dismiss the suit. The district court had ruled in 2008 that the patents were invalid, but did not agree with Roche’s claims of ownership. According to the appeals court, the district should not have addressed the patents’ validity because Stanford didn’t own the IP to begin with.

This was considered, by many, to be a complete victory for Roche.

Stanford first sued Roche in 2005, seeking more than $200 million for the alleged infringement of three patents assigned to Stanford — US Nos. 5,968,730; 6,503,705; and 7,129,041. The three patents descend from a common parent application and share the same title: “Polymerase Chain Reaction Assays for Monitoring Antiviral Therapy and Making Therapeutic Decisions in the Treatment of Acquired Immunodeficiency Syndrome.”

The test was developed, and is currently used, to measure the viral load of HIV in a person’s blood, by measuring the amount of HIV RNA present in the bloodstream. The original description of the use of the PCR to measure HIV RNA was published in the Journal of Infectious Disease in 1991.

For the complete article, please refer to www.hivtestingblog.com/original-articles/

Minister of Health, Dr. Leslie Ramsammy signed an agreement with the Clinton Foundation HIV/AIDS Initiative (CHAI) that supports a program in various areas. The program includes a steady supply of aniretroviral medication, CD4 testing, diagnosis and monitoring and nutritional supplements among other initiatives.

Alfredo Idiarte of CHAI said his organization is committed to the program and will work towards making it more comprehensive. He also said that CHAI is looking at providing deoxyribonucleic acid Polymerase chain reaction (DNA PCR) tests for infant diagnosis. The DNA PCR test looks for direct (DNA) evidence of the virus rather than the antibodies. Currently the tests do not detect evidence of the virus in children younger than 18 months. Early detection could drastically improve treatment options.

*For the original article please refer to http://hivtestingblog.com/original-articles/.

Roche Diagnostic Systems Inc.’s Amplicor H.I.V.-1 monitor test for use in determining viral load in individuals infected with HIV has received FDA approval for marketing. The test uses polymerase chain reaction (PCR) technology to measure HIV genetic material in the blood.

In laboratory studies, the Amplicor test was able in some cases to detect as few as 400 copies of HIV DNA in a blood sample and could regularly detect m800 or more copies.

Two clinical trials of Amplicor were conducted in patients with advanced HIV infection who had received no antiviral treatment or treatment for less than 16 weeks. The results showed that high viral load before anti-HIV therapy, or large increases in viral load after treatment, correlated with increased risk of disease progression to full-blown AIDS.

HIV-1 diagnosis in babies born to seropositive mothers is one of the challenges of HIV epidemics in children. A simple, rapid protocol was developed for quantifying HIV-1 DNA in whole blood samples and was used in the ANRS French pediatric cohort in conditions of prevention of mother-to-child transmission. A quantitative HIV-1 DNA protocol (LTR real-time PCR) requiring small blood volumes was developed. First, analytical reproducibility was evaluated on 172 samples. Results obtained on blood cell pellets and Ficoll-Hypaque separated mononuclear cells were compared in 48 adult HIV-1 samples. Second, the protocol was applied to HIV-1 diagnosis in infants in parallel with plasma HIV-RNA quantitation. This prospective study was performed in children born between May 2005 and April 2007 included in the ANRS cohort. The assay showed good reproducibility. The 95% detection cut-off value was 6 copies/PCR, that is, 40 copies/10(6) leukocytes. HIV-DNA levels in whole blood were highly correlated with those obtained after Ficoll-Hypaque separation (r = 0.900, P < 0.0001). A total of 3,002 specimens from 1,135 infants were tested. The specificity of HIV-DNA and HIV-RNA assays was 100%. HIV-1 infection was diagnosed in nine infants before age 60 days. HIV-DNA levels were low, underlining the need for sensitive assays when highly active antiretroviral therapy (HAART) has been given. The performances of this HIV-DNA assay showed that it is adapted to early diagnosis in children. The results were equivalent to those of HIV-RNA assay. HIV-DNA may be used even in masked primary infection in newborns whose mothers have received HAART. J. Med. Virol. 81:217-223, 2009. (c) 2008 Wiley-Liss, Inc.

All too often, teenagers are going to their doctor’s office with flu-like symptoms, aches and pains, etc.- having some routine blood work done – and when everything comes back negative they are sent home with no-questions-asked. A few weeks later (symptoms still persistent) the teens return to have more blood work. This time the HIV test comes back positive. “What caused this,” or “how did this happen” are often the response that doctors get.

Most often the tests used to detect HIV are antibody tests. The antibodies they are trying to detect usually do not fully develop for several weeks in most people, so if someone were to try to take this test only a week or two after infection chances are they would receive a false negative.

Allison Agwu, M.D., a pediatric infectious disease specialist at John Hopkins Children’s Center, explains that these false negatives usually occur during the most contagious stage of HIV infection – the earliest one. If teenagers are engaging in risky sexual behavior, their need for more extensive testing is increased. Often doctors will ignore these possibilities because of the age of the patients.

If the teen is at high risk they should consider the use of a polymerase chain reaction (PCR) test, which detects genetic markers instead of antibodies. These tests have significantly smaller window periods than antibody tests. While they are more expensive than the standard antibody test, PCR tests allow us to get accurate results at around two or three weeks.

Doctors should consider using a PCR if the patient has used injectible drugs or has two or more of the following symptoms: enlarged lymph nodes, night sweats, malaise/fatigue/headaches or rash, fever/chills, or a persistent sore throat or cough.

* For the complete article, please visit http://hivtestingblog.com/original-articles/