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Pharmaceutical Products

This section of provides information on the pharmaceutical products that are approved for marketing in one or more countries around the world.

Roche has been committed to helping people living with HIV infection since the advent of HIV therapy. The product portfolio began with the development of the ELISA tests and went on to introduce Hivid® (zalcitabine, or ddC), a reverse transcriptase inhibitor which provided the opportunity to combine antiretroviral agents to combat HIV more effectively.

Roche's ongoing commitment to HIV care led to the introduction of the Roche Amplicor HIV-1 Monitor®. This market leading technology has redefined clinical management, allowing physicians to directly measure the viral load of individual patients and determine the efficacy of their treatments. In addition, Roche Amplicor has proven to be a valuable tool for drug development and HIV research. Roche molecular systems have continued to develop the Roche Amplicor HIV-1 monitor to detect extremely low levels of virus (50 copies/ml) and variations in HIV-1 subtypes.

In 1995, Roche introduced Invirase® (saquinavir), the world’s first HIV protease inhibitor that marked a seminal change in the treatment of HIV infection. Only now was it possible to inhibit two different stages of the HIV lifecycle, thus allowing for highly active antiretroviral therapy (HAART). The use of protease inhibitors combined in HAART regimens led to the discovery of 'PI-boosting'. Initial pilot studies using Roche Amplicor found that when Invirase was administered with ritonavir (Norvir®), a significant increase in saquinavir plasma levels led to highly potent viral suppression. Further clinical trials have shown that saquinavir with a mini-dose of ritonavir at a dose of 1000/100 mg bid provides maximal viral suppression but with a reduction in ritonavir-associated side effects – therefore offering a combination of high efficacy with a good safety profile. More recently, Roche has optimized saquinavir with the introduction of a 500 mg tablet (Invirase 500), such that the pill burden is significantly reduced from five to two tablets twice daily (plus one ritonavir capsule). US and EU approval were given in December 2004 and May 2005, respectively.

In 1998, Roche introduced Viracept®, a new protease inhibitor licensed from Pfizer. Viracept is one of several currently available protease inhibitors used to limit viral replication and improve immune function in HIV-infected individuals. It is administered in combination with other antiretroviral agents.

In 2001, Roche received approval to use Valcyte®, an oral pro-drug of ganciclovir, to treat CMV in HIV-infected patients providing a more convenient regimen for maintenance therapy.

The growing prevalence of drug-resistant virus in the community means that there is an urgent need for drugs that are active against resistant HIV strains. Roche and Trimeris co-developed FUZEON ® (enfuvirtide), the first of a new class of antiretrovirals with a completely novel mode of action, the fusion inhibitors. Because it acts at a different mechanistic site, FUZEON is active against virus that is resistant to the other three classes of antiretroviral agents (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors) and is most effective when used in combination with other active antiretrovirals. FUZEON received approval from the US Food and Drug Administration (FDA) in March 2003 and from the European Commission in May 2003.

Over the past few years, concomitant infection ("co-infection") with HIV and hepatitis C virus (HCV) has emerged as a major public health concern. In response to the growing need for more effective anti-HCV treatments, Roche has developed PEGASYS® (peginterferon alfa-2a [40KD]). Several studies have provided evidence supporting the use of PEGASYS® in combination with COPEGUS® (ribavirin) in the treatment of hepatitis C in HIV–HCV co-infected individuals. The largest of these has been the AIDS PEGASYS® Ribavirin International CO-Infection Trial (APRICOT). PEGASYS® has been approved for use in HIV–HCV co-infected patients in Europe and the USA.

If you have any questions regarding any Roche HIV products, please e-mail: [email protected] .  

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