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TherapyEdge and IAPAC Collaborate to Improve HIV Patient Outcomes

Web-Based Software Designed to Support HIV Patient Management and Enhanced Clinical Response

August 2002

Article: TherapyEdge and IAPAC Collaborate to Improve HIV Patient Outcomes

TherapyEdge, Inc. announced in July 2002 that it will collaborate with the International Association of Physicians in care (IAPAC) to provide members worldwide with access to the TherapyEdge-HIVTM system. TherapyEdge-HIV is a Web-based software program that employs artificial intelligence to assess a patient's clinical status, alert for potential medical issues, and present viable, individualized therapy options based on their likelihood of success, in real time.

As part of the newly announced collaboration, TherapyEdge is offering IAPAC members two weeks of complementary access to TherapyEdge-HIV. For details regarding TherapyEdge-HIV complementary access, and special subscription pricing, please contact IAPAC Director of Membership Joey Atwell at, or register directly with TherapyEdge at

"TherapyEdge-HIV," stated John W. Mellors, Chief of Infectious Diseases and Director of the HIV/AIDS Program at the University of Pittsburgh, "does in milliseconds what would take me 20 or 30 minutes sitting down in a quiet room, leafing through a patient's charts, checking the past medical history, virus resistance profiles, drug doses and interactions, pulling together all my knowledge."


Complete Patient Assessment

TherapyEdge-HIV graphically tracks and automatically processes a patient's clinical data -- including medical conditions, medications, genetic tests for drug resistance, drug efficacy, and toxicity data -- through an extensive knowledge base of pharmacological and clinical information. These knowledge bases are created and continuously maintained in collaboration with world-renowned HIV clinicians and researchers. The system's intelligent alerting system checks for drug interactions, medical conditions or side-effect issues, as well as abnormal lab results and drug dosing. When a change in therapy is indicated, TherapyEdge's advanced artificial intelligence engine and knowledge base instantly generates patient-specific, optimized treatment alternatives that clinicians can review and compare. Clinicians can use the system to rapidly transform disparate data into individualized comprehensive treatment plans for patients. TherapyEdge distributes this actionable medical knowledge anywhere in the world to subscribers via the Internet. Additionally, the system deidentifies patient data and provides a longitudinal database that can be queried for drug efficacy data, clinical outcomes, and quality of care information. The system can therefore support the validation and effectiveness of health services and therapeutic interventions.

"TherapyEdge HIV gathers and integrates patient data, the latest clinical research, and therapy options in a way that would otherwise take an enormous amount of time for me to do diligently," said Gary Blick, Medical Director of CICLE Medical in Norwalk, Connecticut, a TherapyEdge clinical evaluation site. "Since TherapyEdge focuses this knowledge on an individual-patient basis, it simplifies the onerous research and administrative tasks that would otherwise take me away from delivering quality personalized patient care."

Comprehensive HIV Genomic Analysis

Like other systems, TherapyEdge-HIV can search gene sequences for mutations among the 99 protease and 560 reverse transcriptase codons and report which drugs to avoid. But TherapyEdge-HIV surpasses other systems by considering not just how mutations affect single drugs, but how they affect combinations. For example, with M184V, where valine replaces methionine at position 184, most programs warn that M184V makes HIV resistant to lamivudine (3TC), ignoring that it also increases susceptibility to zidovudine (ZDV). In combinations using ZDV (and if there are no other ZDV-related mutations), TherapyEdge-HIV recommends prescribing 3TC to maintain selective pressure for the mutation's retention, so that ZDV can be potentiated. TherapyEdge-HIV also considers ways to overcome resistance through higher doses or inhibiting drug metabolism to make the drug last longer in the body. The system interprets virtual phenotype and actual phenotype data in a similar manner.

Rationale for TherapyEdge-HIV

For a patient never before treated, initial therapies are easily selected and can often keep HIV at bay for years. But as many as half of all patients either cannot tolerate their medications' side effects, or HIV acquires drug resistance. Given fewer therapeutic options, clinicians sometimes struggle to determine viable alternatives. Issues ranging from pill burden and side effects to dose adjustments, complexities of administration and co-morbid conditions further complicate the decision-making process.

That there are now thousands of combinations, including "boosted" protease inhibitor hybrids, does not make the selection process easy. "The virus changes into an almost endless variety of forms," explained Mellors, an authority on HIV drug resistance. "Individuals react differently to different medicines. The medications interact in so many different ways that you can't keep them in your head with any accuracy. To keep these things sorted out and optimized is a real challenge." Indeed, the body of knowledge required to make a good choice -- keeping the pill burden light, avoiding bad drug interactions and exploiting good ones, sidestepping drug toxicities -- is constantly evolving.

With TherapyEdge-HIV, the clinician inputs the patient's characteristics "and with a series of keystrokes asks the artificial intelligence system what regimens it would recommend and rank them," said Donna Mildvan, Chief of the Infectious Diseases Division at Beth Israel Medical Center in New York. Working by "the rules of the best practices according to a panel of experts," she said its answers are "very comparable" to what experts recommend.

TherapyEdge-HIV has undergone extensive evaluation and testing in clinical centers with large numbers of HIV-infected patients, and is the result of five years of development and collaboration with leading clinicians and researchers in the field of HIV/AIDS, pharmacologists, and leading software experts.

How TherapyEdge-HIV Works

TherapyEdge-HIV combines information derived from evidence in the medical literature, expert medical opinion, standardized drug databases -- augmented in the area of HIV antivirals -- and standard medical terminology as the basis for clinical decision support. The information contained in the system is continuously updated to reflect the latest available knowledge in the field of HIV/AIDS.

Four knowledge base subsystems -- pharmacology, resistance, clinical data, and therapy assessment -- are used to continuously assess a patient's status. These subsystems, integrated with the system's artificial intelligence technology, generate the patient-specific alerts/warnings, based on analyses of laboratory as well as resistance test results, current/prior medical conditions, allergies and current or previous medications.

When a change in HIV therapy is necessary, the system looks at all the possible ways of treating a patient, eliminates those that are contraindicated, and sorts the remainder from the most to the least fit by using thousands of filtration rules. For example, if a drug causes a patient an allergic reaction, filtration drops it from further consideration. In addition, tournament rules rank the drug combinations that pass through the sieve of filtration rules. Tournaments weigh combinations in terms of criteria doctors judge important for effective therapy and patient compliance, including potency, regimen simplicity, and preserving other treatment options if resistance develops. Tournament rules, like filtration rules, get updated continuously as HIV medicine progresses. Together with HIV resistance interpretation, the filtration and tournament rules bring to bear the disparate details and emerging research an HIV specialist may know, but that might slip a busy mind pressed for time.

TherapyEdge-HIV can therefore rapidly generate patient-tailored treatment options in milliseconds. Or, "the alternative [task] for the user," comments Mildvan, "is to say 'Here is what I, the clinician, am considering using. Do you see any problems with that? Do you see any preferences for other regimens?' In other words, how does artificial intelligence see my choice? It's really a cross check of your judgment as a clinician."

About TherapyEdge, Inc.

TherapyEdge, Inc. was founded in 2000 after receiving US$12.5 million in private financing from Tibotec-Virco, a subsidiary of Johnson & Johnson, Inc., and Pythagoras Participations. The company, which is based in Durham, North Carolina, has a staff of 20 in the areas of pharmacology, HIV clinical research, software development, artificial intelligence, and related technologies. A clinical advisory panel comprised of distinguished researchers and specialists in the area of HIV/AIDS has been collaborating on the development of TherapyEdge-HIV since inception. The late David W. Barry, former CEO of Triangle Pharmaceuticals, first conceived and started working on the TherapyEdge-HIV product in 1997. For further details on the company, visit

Back to the August 2002 issue of IAPAC Monthly.

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This article was provided by International Association of Physicians in AIDS Care. It is a part of the publication IAPAC Monthly.