What is Zerit?
Zerit is a medicine that contains the active substance stavudine. Zerit is available as capsules each containing 15 mg (red and yellow capsule), 20 mg (brown capsule), 30 mg (light and dark orange capsule) or 40 mg (dark orange capsule) of stavudine. Zerit is also available in powder form for the preparation of a solution to be administered by mouth.
What is Zerit used for?
Zerit is an antiviral drug. it is used in combination with other antiviral medicines in the treatment of adults and children infected with human immunodeficiency virus (HIV), which is the virus that causes the acquired immunodeficiency syndrome (AIDS).
The medicine can only be obtained with a prescription.
How is Zerit used?
Treatment with Zerit should be established by a doctor who has experience in the treatment of HIV infection. The dosage should be calculated based on the patient's age and body weight and should be taken every 12 hours; adults weighing less than 60 kg and children / adolescents weighing more than 30 kg: 30 mg; adults weighing more than 60 kg: 40 mg; adolescents over 14 years: 1 mg per kg of body weight, unless they weigh over 30 kg; infants less than 13 days: 0.5 mg per kg of body weight.
Zerit should be taken on an empty stomach at least 1 hour before meals. If this is not possible, it can be taken with a light meal. The capsules should be swallowed whole or you can open them carefully and mix the contents with the food. The oral solution should be used in patients under the age of three months. For patients with kidney problems or in whom certain side effects occur, dosage adjustment may be necessary. For more information, see the package leaflet.
How does Zerit work?
The active substance in Zerit, stavudine, is a nucleoside reverse transcriptase inhibitor (NRTI) that blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and reproduce. By blocking the enzyme, Zerit, taken in combination with other antiviral drugs, reduces the amount of HIV in the blood, keeping it at a reduced level. Zerit does not cure HIV infection or AIDS, however it can delay the damage to the immune system and the development of infections and diseases associated with AIDS.
How has Zerit been studied?
The effectiveness of Zerit has been the subject of four main studies. The first study compared the effectiveness of Zerit taken alone and zidovudine (another antiviral drug) in 822 HIV-infected patients who had been treated with zidovudine for at least six months. The main measure of effectiveness was the time until the onset of a disease associated with AIDS or until the patient died. In the second study, two doses of Zerit were compared on over 13, 000 patients who did not respond or could not be treated with other types of antiviral drugs. The study measured survival rates.
Two other studies evaluated the efficacy of Zerit taken in combination with lamivudine and efavirenz (other antiviral drugs) in 467 naïve patients, that is never previously treated against HIV infection. The main efficacy parameters were the levels of HIV in the blood (viral load) and the number of CD4 T lymphocytes in the blood (CD4 cell count) after 48 weeks of treatment. CD4 T lymphocytes are white blood cells that play an important role in fighting infections but are destroyed by HIV.
What benefit has Zerit shown during the studies?
Studies have shown that Zerit was effective in reducing disease progression rates in HIV-infected patients. Patients treated only with Zerit have developed a disease associated with AIDS or have died in percentages similar to those observed in patients treated with zidovudine. Patients treated with one of the two study doses also showed similar survival rates over 22 weeks.
Concerning the combined intake of Zerit with lamivudine and efavirenz, after 48 weeks a viral load of less than 400 copies / ml was found in approximately 70% of patients treated. CD4 cell counts also increased from about 280 cells / mm3 before treatment to an average of about 185 cells / mm3.
What is the risk associated with Zerit?
The most common side effects (ie observed in a number between 1 and 10 patients in 100) associated with Zerit use are peripheral neuropathy (damage to the nerves of the extremities that causes tingling, numbness and pain in the hands and feet), diarrhea, nausea, abdominal pains, dyspepsia (heartburn), fatigue, lipodystrophy (redistribution of body fat), dizziness, insomnia, altered thinking, drowsiness, depression, rash, itching and hyperlactataemia (high levels of lactic acid in the blood). For the full list of all side effects reported with Zerit, see the Package Leaflet.
Zerit should not be used in patients who may be hypersensitive (allergic) to stavudine or any of the other ingredients.
As with other anti-HIV drugs, patients treated with Zerit may have a risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovery of the immune system). Patients with liver problems (including hepatitis B or C infection) may be at an increased risk of liver damage if treated with Zerit. Like all other NRTIs, Zerit can also cause lactic acidosis (accumulation of lactic acid in the body) and, in newborns of mothers treated with Zerit during pregnancy, mitochondrial dysfunction (injuries to the constituents that act as power plants within the cells and therefore can cause blood problems).
Why has Zerit been approved?
The Committee for Medicinal Products for Human Use (CHMP) found valid indications of the effectiveness of Zerit when taken with other antiviral drugs in the treatment of HIV infection in adults, concluding furthermore that there are positive data which, although limited, indicate the effectiveness even in HIV-infected children.
The Committee decided that the benefits of Zerit taken in combination with other antiretroviral drugs outweigh the risks in the treatment of HIV-infected patients and therefore recommended that Zerit be given marketing authorization.
More information on Zerit:
On 8 May 1996, the European Commission granted Zerit a marketing authorization valid throughout the European Union to BRISTOL-MYERS SQUIBB PHARMA EEIG. This authorization was renewed on 8 May 2001 and 8 May 2006.
For the full EPAR for Zerit, click here.
Last update of this summary: 12-2007.
