IMPORTANT PROGRESS IN TREATMENT OF HIV INFECTION TO BE REPORTED
New strategies for using Roche’s existing anti-HIV portfolio and progress in the development of new drugs will be presented at the World AIDS Conference in Durban, South Africa
BASEL - 10 July, 2000 - Promising results of a number of Roche anti-HIV research initiatives covering the diagnosis, surveillance and management of the virus will be presented by several internationally respected scientists this week at the XIIIth World AIDS Conference in Durban, South Africa. These initiatives have been designed to enhance understanding of the current standards of treatment, improve the lives of people living with HIV, and explore the development of new treatments including an entirely new class of agents called fusion inhibitors. Scientists and physicians involved in the research efforts are encouraged by the results which represent advances in the fight for greater suppression of HIV and the management of its resistance and cross-resistance to currently available drugs.
Roche has specified HIV/ AIDS as a key area and focusses a wide range of its research and development activities to improve existing treatments and to develop entirely new compounds to fight HIV.
Current Treatments: Improved Adherence, Better Quality of Life and Increased Drug Exposure
Specifically, Roche has undertaken efforts to make long-term treatment with its clinically-proven products Viracept and Fortovase easier to use for people with HIV infection. A number of studies demonstrate that protease inhibitor-containing treatment regimens including Viracept or Fortovase taken two times per day instead of three times per day can achieve adequate long-term efficacy while encouraging or improving adherence to treatment. Data available today indicate that such a simplified regimen improves compliance by minimizing pill burden and, in turn the efficacy of therapy. Equally important, for people taking these medicines, the findings represent a significant simplification of complex dosing regimens and an improvement in quality of life.
Additionally, early results of studies exploring the use of Viracept or Fortovase administered once a day in combination with low doses of ritonavir showed that the blood levels of the protease inhibitor boosted by ritonavir were comparable or higher compared to those resulting from the approved regimen. "In boosting the blood concentration of a protease inhibitor by blocking the enzymes that breaks it down in the body, we see several important advantages. We should be able to reduce the complexity and the pill burden of the treatment regimen, as well as the variability in bioavailability among individuals. Such an approach may improve long-term virological suppression and may significantly delay the development of resistance to treatment," says Dr Julio Montaner, Professor of Medicine, University of British Columbia, Canada.
Sensitive and specific testing - the foundation for long-term treatment success
Viral load tests are an "essential parameter" in treating HIV/AIDS, and when used in conjunction with other indices such as CD4+ counts, provide a more complete picture of a person’s disease progression and response to therapy. The advent of the AMPLICOR HIV-1 MONITOR Test, a Polymerase Chain Reaction (PCR) based assay in 1996 was considered a great advance in the battle again HIV/AIDS. Following this, further advances were made with the introduction of the UltraSensitive Method which is capable of measuring the amount of HIV in an infected person’s bloodstream down to as low as 50 copies/mL of plasma. This is critical since reducing HIV RNA to below 50 copies/mL has been associated with a more complete and durable viral suppression.
Today, there is a new advance in HIV diagnostic technology: the COBAS AMPLICOR HIV-1 MONITOR Test version 1.5. "Automating the amplification and detection steps of the PCR process offers a solution to both clinical and laboratory demands for routine quantification," said Claudia Balotta, MD, University of Milan, Italy. Additionally, while the predominate subtype in the United States and Western Europe is subtype B, a broad range of divergent strains have been found in Asia and Africa. Measurement of HIV-1 across these subtypes is essential for accurate assessment of disease prognosis and response to antiretroviral treatment. The COBAS AMPLICOR HIV-1 MONITOR Test version 1.5 accurately quantitates HIV-1 across subtypes A-G and ensures accurate results regardless of subtype variability.
Research and Development of New Treatments: Protease Inhibitors and Reverse Transcriptase Inhibitors
To address the need for new therapies, two Roche discovery programs have focussed on developing new protease inhibitors and reverse transcriptase inhibitors. The aim of the HIV protease inhibitor program is to produce a compound with an optimal pharmacokinetic profile and activity against resistant isolates of the virus selected by the existing protease inhibitors. Early in vitro data for two new candidate protease inhibitors discovered by Roche were presented by Dr. Matei Popescu, Medical Director, Roche Basel, Switzerland. They showed highly potent activity against so called wild-type virus. More importantly, these two new compounds showed similar activity against virus which exhibited strong cross resistance to a number of currently available protease inhibitors including ABT-378 (lopinavir). "These are the fruits of a very intensive program in our Virology Discovery Center in Welwyn, Roche UK. We’ve set tough standards for these new compounds to make sure they’re a good match for the new viral strains that are emerging. These data looks like we may have something worth accelerating into human study" comments Dr Popescu.
Research and Development of New Treatments: Fusion Inhibitors
Recently scientists have started to elucidate how HIV attaches to and subsequently infects human cells. This process appears to be characterized by a number of defined steps including initial attachment of the virus to the cell which is followed by a process called fusion where the virus and host cell fuse together allowing infection of the cell. T-20 and T-1249 are the first two fusion inhibitors to enter clinical development and are being co-developed by Roche and Trimeris Inc., USA. Because T-20 and T-1249 target a different part of the viral life cycle compared to currently approved antiretrovirals it is expected that these fusion inhibitors will be active against virus that is resistant to the current classes of anti-HIV drugs.
Data from an ongoing phase II trial suggest that when used in combination with other antiretroviral therapies, T-20, the first drug in this investigational class, continues to be well tolerated and may contribute to the observed suppression of viral load in people with HIV out to 48 weeks of therapy. We are happy to see the tolerability and antiviral activity trends continue over the course of this year-long evaluation of T-20 combination regimens in the enrolled difficult to treat patients," said Dr. Cohen, Director of the Community Research Initiative of New England, who will be presenting the results. "A substantial number of people living with HIV/AIDS have exhausted many of the drug options which are available today, and we welcome continued progress with new classes of HIV/AIDS medications." While the data available on this new class of treatments is very promising, additional information from ongoing research and phase III clinical studies is necessary to confirm what has been seen until now.
Further, a research collaboration between Roche and Progenics Pharmaceuticals Inc. USA, is currently underway to discover an orally bioavailable inhibitor targeted against the human receptors at which HIV binds. "From the outset, our antiviral focus has been driven by teamwork, innovation, and a great sense of urgency. The HIV virus has spread fast and changed fast. As a company we are committed to combating it on both of these fronts. Roche is dedicated to continuing its research to improve, prolong, and save the lives of people living with HIV/AIDS. We saw our protease inhibition and PCR technology help many people leave their sick beds and return to more regular lives, and hope that fusion inhibition will allow for another, similar major step forward in the future." says Dr. David Reddy, Franchise Leader, Virology, Roche. For accurate, up-to-the-minute information on HIV, its risk factors, symptoms, diagnosis and treatment options, visit www.Roche-HIV.com. Here you will also find information on the BlueSky Initiative, Roche’s support program in HIV.
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