|
If you are a Healthcare Professional please click here for detailed product information.
Go to Product SmPCs
Pharmaceutical Products
Roche�s commitment to developing products that help people living with HIV infection has its roots in the beginnings of the disease. Starting with the development of the ELISA tests, Roche technology became critical in identifying the true nature and breadth of the disease. Roche went on to introduce Hivid� (zalcitabine, or ddC), a reverse transcriptase inhibitor that provided the opportunity combine antiretroviral agents to combat HIV more effectively.
A few years later Roche introduced saquinavir, the world�s first HIV protease inhibitor. The introduction of the protease inhibitor class marked a seminal change in the treatment of HIV infection. For the first time it was possible to inhibit two different stages in the HIV lifecycle, thus allowing for highly active antiretroviral therapy (HAART).
At the same time as Roche was introducing Invirase�, the company was hard at work on a revolutionary new diagnostic test that would directly measure the amount of HIV in the blood. Based on polymerase chain reaction (PCR) technology, the Roche Amplicor HIV-1 Monitor� allowed physicians to determine efficacy of treatments in individual patients, enabling more effective clinical management in addition to providing a valuable tool for drug development and HIV research.
Data from large clinical endpoint studies including Roche's NV14256 and SV14604 (PISCES) studies established a correlation between viral load, measured as HIV-1 RNA , and clinical outcome. The Amplicor� assay demonstrated that when used as the sole protease inhibitor in a combination regimen Invirase� provides only modest reductions in viral load due to its limited bioavailability. A pilot study exploring high doses of Invirase� showed greater reductions in HIV RNA, and prompted the investigation of combining Invirase� with ritonavir to significantly increase saquinavir blood levels as well as the development of an improved formulation of saquinavir, Fortovase�. When used at the recommended dose, Fortovase� provides saquinavir blood levels that are around 8-fold higher than can be achieved with the recommended dose of Invirase�.
These two products � protease inhibitors used in combination treatment regimens and PCR technology to measure HIV viral load � have redefined the clinical management of HIV infection. Roche is continuing to focus its HIV product development on meeting the needs of those living with the virus. This has resulted in an acknowledgement of the need to treat the significant proportion of HIV-positive patients who are co-infected with hepatitis C virus. Pegasys� (pegylated inteferon alfa-2a) is the most recently approved product in the Roche HIV portfolio. It is a potent inhibitor of hepatitis C virus and is indicated for use in patients with HIV/HCV co-infection.
In addition to introducing Fortovase�, Roche has continued to bring forward new and improved products through its own research efforts and through in-licensing activities. In 1998 Roche introduced Viracept�, a new protease inhibitor licensed from Agouron Pharmaceuticals. Roche is currently in the process of introducing Valcyte�, an oral pro-drug of ganciclovir which can replace the i.v. induction phase of CMV treatment and provides a more convenient regimen for maintenance therapy. Similarly, Roche Molecular Systems have introduced a more sensitive Amplicor� test that can detect HIV RNA present at extremely low levels (50 copies/ml).
Beyond strengthening existing weapons against HIV, Roche is also developing entirely new antiretroviral agents. Roche scientists are currently working on the development of agents that inhibit the fusion of HIV with the host cell. By blocking the process that HIV uses to infect healthy cells, the fusion inhibitors currently undergoing clinical development may provide a powerful new way to treat people with HIV. More information on fusion inhibition is provided in the R&D section of this website.
This section of Roche-HIV.com provides information on the pharmaceutical and diagnostics products that are approved for marketing in one or more countries around the world.
If you have any questions regarding any Roche HIV products, please e-mail:
[email protected].
| 
