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| |  FDA Approves Valcyte (Valganciclovir) For Cytomegalovirus Retinitis In AIDS Patients NUTLEY, NJ -- March 30, 2001 -- Hoffmann-La Roche announced that the U.S. Food and Drug Administration (FDA) has approved Valcyte™ (valganciclovir) for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. Valcyte is the oral pro-drug of Roche's existing anti-CMV treatment, Cytovene (ganciclovir), which is currently the most widely prescribed anti-CMV medication worldwide. In a clinical study, Valcyte tablets were found to have comparable efficacy for induction therapy when compared to Cytovene-IV. The application for Valcyte received a priority review from the FDA, a designation reserved for treatments deemed to represent potentially major advances in healthcare. The product is expected to be available in pharmacies in late spring 2001. "Since Cytovene was introduced in 1989, it has become the mainstay of anti-CMV treatment in patients with HIV/AIDS," said Georges Gemayel, vice president, marketing, Roche Laboratories. "We expect that Valcyte will replace and build upon Cytovene in the marketplace, because it offers comparable efficacy in a much more convenient dosing regimen for induction therapy." "CMV retinitis, which can lead to blindness, affects between 10 and 25 percent of people with the late stages of AIDS," said Terje Anderson, executive director, National Association for People with AIDS (NAPWA). "It's devastating to these patients to lose their eyesight at the same time they are fighting to survive. During the past few years, advances in treatment for HIV/AIDS have decreased the prevalence of opportunistic infections like CMV; however, there is still a need for convenient treatment regimens versus drugs currently available for induction therapy for CMV retinitis," Anderson added. For patients with active CMV retinitis, the recommended induction dose of Valcyte is two 450mg tablets twice a day for 21 days. Following induction treatment, or for patients with inactive CMV retinitis who require maintenance therapy, the recommended dose is two 450mg tablets once daily. The safety and efficacy of Valcyte has been demonstrated in a controlled study involving 160 patients with AIDS and newly diagnosed CMV retinitis who were randomized evenly to receive Valcyte or Cytovene-IV for a four-week induction treatment phase. The pivotal trial compared treatment with Valcyte (900mg twice daily for 21 days, then 900mg once daily for seven days) or with Cytovene-IV (5mg/kg twice daily for 21 days, then 5mg/kg once daily for seven days). After week four, the 154 patients continuing therapy received open-label Valcyte (900mg once daily) for maintenance. Analysis of the primary CMV progression endpoint revealed that after four weeks of therapy, the proportion of patients with progression as measured by retinal photography was the same in both treatment groups. In the Cytovene-IV arm, seven progressed, 63 did not progress and 10 were unevaluable. In the Valcyte arm, seven progressed, 64 did not progress and nine were unevaluable. After week four, all patients were allowed to continue to receive maintenance treatment with 900mg of Valcyte once daily. Safety data were submitted for 370 patients who received Valcyte for an average of 320 days. In clinical studies, the toxicity of Valcyte, which is metabolized to ganciclovir, includes low blood cell counts (granulocytopenia 27 percent), anemia (26 percent), and thrombocytopenia (6 percent) as well as diarrhea (41 percent), nausea (30 percent), vomiting (21 percent), abdominal pain (15 percent), fever (31 percent), headache (22 percent), insomnia (16 percent), peripheral neuropathy (9 percent), paresthesia (8 percent) and retinal detachment (15 percent). In animal studies, ganciclovir was carcinogenic, teratogenic and caused aspermatogenesis. Valcyte tablets cannot be substituted for Cytovene capsules on a one-to-one basis. If renal function is impaired, dosage adjustments are required. Valcyte must be taken with food. Because it is an oral formulation, Valcyte eliminates the risk of catheter-related sepsis. As a pro-drug of ganciclovir, Valcyte is rapidly converted to ganciclovir in the body. Phamacokinetic studies have demonstrated the bioavailability of ganciclovir from Valcyte is increased 10-fold compared to the oral formulation of Cytovene, and two 450mg Valcyte tablets one or two times daily achieved systemic exposure of ganciclovir comparable to that achieved with the recommended doses of intravenous Cytovene of 5mg/kg once or twice daily, respectively. Cytomegalovirus (CMV), a member of the herpes family of viruses, infects approximately 50 to 75 percent of the U.S. adult population. In individuals with healthy immune systems, CMV exists in the body in a dormant state. Among individuals with compromised immune systems, such as those with HIV/AIDS or patients taking post-transplant immunosuppressants, the virus can become active and cause disease. In people with HIV/AIDS, the most common manifestation of CMV is CMV retinitis, a sight-threatening form of this disease. Although retinitis may develop without symptoms, when symptoms do occur they include visual problems, such as blind spots, distorted vision and noticeable blurring. Because these problems can happen in diseases other than CMV retinitis, a physician must make the diagnosis of CMV retinitis. SOURCE Hoffmann-La Roche Inc.
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