PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Vistide?
Vistide is a concentrate to be diluted in a solution for infusion (drip into a vein). It contains the active substance cidofovir (75 mg / ml).
What is Vistide used for?
Vistide is used in the treatment of cytomegalovirus (CMV) retinitis, a viral infection of the retina (the light-sensitive membrane that covers the inner part of the eye). This disease can cause vision loss. Vistide is used in patients with acquired immunodeficiency syndrome (AIDS) who do not suffer from kidney disease and should only be used if treatment with other drugs is not possible.
The medicine can only be obtained with a prescription.
How is Vistide used?
Treatment with Vistide should be prescribed by a doctor experienced in the management of human immunodeficiency virus (HIV) infection. Before taking Vistide it is necessary to assess the patient's renal function, as the medicine should not be given to patients with kidney diseases. In the "induction" phase, 5 mg of Vistide per kilogram of body weight should be administered by an hour-long infusion, once a week for the first two weeks. Subsequently, in the "maintenance" phase, the administration should be carried out once every two weeks. Treatment should therefore be continued for the duration recommended in local guidelines on the management of HIV-infected patients.
To limit the risk of kidney damage, patients must also take another medicine, probenecid (2 g three hours before the infusion, then 1 g to two and eight hours after the infusion), and be given an infusion of a liter of saline one hour before the Vistide infusion. Probenecid is used to prevent the accumulation of cidofovir in the kidneys, while the saline solution is used to prevent dehydration.
How does Vistide work?
The active ingredient contained in Vistide, cidofovir, is an antiviral drug of the class of "nucleoside analogues" that blocks the activity of a particular enzyme called "DNA polymerase" of CMV, used by the virus to produce DNA. When the virus is unable to produce DNA, it cannot reproduce, which slows down the spread of infection.
What studies have been carried out on Vistide?
The effects of Vistide in patients with AIDS with CMV retinitis have been the subject of a treatment study and a maintenance study. The treatment study, conducted on 48 patients previously not treated with any drug for CMV retinitis, compared the effects of Vistide compared to cases in which no therapy was used. The maintenance study compared two maintenance doses of Vistide (5 and 3 mg / kg body weight) on 100 patients who no longer responded to other CMV retinitis drugs (ganciclovir or foscarnet) or who could not take such medicines . In both studies, the main efficacy parameter was time spent before the disease got worse.
What benefit has Vistide shown during the studies?
In the treatment study, Vistide was shown to be more effective than cases without treatment. In patients treated with Vistide the worsening of CMV retinitis occurred on average after 120 days, whereas in patients without any treatment the worsening occurred after 22 days. In the maintenance study, the 5 mg / kg dose was more effective than the 3 mg / kg dose (115 and 49 days, respectively).
What is the risk associated with Vistide?
The most common side effects associated with Vistide (ie seen in more than 1 patient in 10) are neutropenia (low white blood cell count), headache, nausea, vomiting, alopecia (hair loss), rash, proteinuria (presence of protein in urine), increased levels of creatinine in the blood (waste product of muscle metabolism), asthenia (weakness) and fever. For the full list of all side effects reported with Vistide, see the Package Leaflet.
Vistide should not be used in patients who are potentially hypersensitive (allergic) to cidofovir or any of the other components. It should also not be used in patients with kidney disease or other medicines that could harm the kidneys, or in patients who cannot be treated with probenecid or other sulfur-containing drugs. Vistide should not be injected directly into the eye.
Why has Vistide been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Vistide's benefits are greater than its risks for the treatment of CMV retinitis in patients with AIDS and without kidney disease, and therefore recommended issuing an authorization in trade for Vistide.
More information on Vistide
On 23 April 1997, the European Commission issued a marketing authorization for Vistide, valid throughout the European Union. This authorization was renewed on April 23, 2002 and April 23, 2007. The marketing authorization holder is Gilead Sciences International.
For the full EPAR for Vistide, click here.
Last update of this summary: 01-2009.
