Stocrin - efavirenz

What is Stocrin?

Stocrin is a medicine that contains the active substance efavirenz. It is available in capsules (yellow and white: 50 mg; white: 100 mg; yellow: 200 mg), in yellow capsules-shaped tablets (600 mg), in round color tablets yellow (50 and 200 mg) and in an oral solution (30 mg / ml).

What is Stocrin used for?

Stocrin is an antiviral medicine, indicated in combination with other antiviral medicines to treat adults and children at least 3 years of age with human type immunodeficiency virus. Patients taking rifampicin (an antibiotic) may need to take a higher dose of Stocrin.

For more details, see the summary of product characteristics (also included with the EPAR).

How does Stocrin work?

Stocrin contains the active substance efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI). It blocks the activity of reverse transcriptase, an enzyme produced by the HIV virus that allows it to infect cells in the body and produce more viruses. By blocking this enzyme, Stocrin, taken in combination with other antiviral drugs, reduces the amount of HIV in the blood, keeping it at a low level. Stocrin does not cure HIV infection or AIDS, but it can

delay the damage to the immune system and the development of infections and diseases associated with AIDS.

What studies have been carried out on Stocrin?

Stocrin has been studied in three main studies involving more than 1 100 adults:

1. the first study compared Stocrin in combination with lamivudine and zidovudine or indinavir (other antiviral drugs) with the combination of indinavir, lamivudine and zidovudine;
2. the second study compared Stocrin in combination with nelfinavir and two other antiviral drugs with the same combination without Stocrin;
3. the third study compared the addition of Stocrin or placebo (a dummy treatment) to a treatment regimen based on antiviral drugs including indinavir and two other antiviral drugs, in patients previously treated for HIV infection.

Stocrin has also been studied in 57 children aged between 3 and 16 years, in combination with nelfinavir and other antiviral drugs.

In all the aforementioned studies, the main measure of effectiveness was the number of patients with HIV-1 levels not appreciable in the blood (viral load) after 24 or 48 weeks of treatment.

What benefit has Stocrin shown during the studies?

Studies have shown that therapeutic combinations involving the use of Stocrin are as effective as the comparator medicines:

1. from the first study it was found that, 48 weeks later, 67% of adults treated with Stocrin in combination with zidovudine and lamivudine showed a viral load of less than 400 copies / ml compared to 54% of patients treated with Stocrin and indinavir, and 45% of those treated with indinavir, lamivudine and zidovudine;
2. in the second study Stocrin in association with nelfinavir gave better results than the combination without Stocrin with, respectively, 70% and 30% of patients with viral loads below 500 copies / ml after 48 weeks of treatment;
3. the results of the third study show that, after 24 weeks, a higher percentage of patients treated with Stocrin had viral loads below 400 copies / ml compared to patients treated with placebo.

Similar results were found in the study on children.

What is the risk associated with Stocrin?

The most common side effects seen with Stocrin (seen in more than 1 patient in 10) are skin rashes. Stocrin may also involve nervous system symptoms such as dizziness, insomnia, drowsiness, difficulty concentrating and alteration of dream activity, and psychiatric disorders including severe depression, suicidal thoughts, suicide attempts and aggressive behavior, especially in patients with a history of mental illness. Taking Stocrin with food may increase the frequency of side effects. For the full list of all side effects reported with Stocrin, see the Package Leaflet.

Stocrin should not be used in people who may be hypersensitive (allergic) to efavirenz or any of the other substances. It must not be used in patients with severe hepatic impairment or being treated with any of the following drugs:

1. astemizole, terfenadine (usually used to treat allergy symptoms - these medicines can be purchased without a prescription);
2. dihydroergotamine, ergotamine, ergonovine, methylergonovine (used in the treatment of migraine);
3. midazolam, triazolam (used for the treatment of anxiety or sleep disorders);
4. pimozide (for the treatment of mental illnesses);
5. cisapride (for the treatment of certain stomach disorders);
6. bepridil (for the treatment of angina);
7. St. John's wort (a herbal preparation used in the treatment of depression).

Finally, precaution should be used in the use of Stocrin in patients taking other drugs at the same time. For more details, see the package leaflet.

As with other anti-HIV drugs, patients receiving Stocrin may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infections caused by the reactivation of the immune system ). Patients with liver problems (including hepatitis B or C) may be at high risk of developing liver damage if treated with Stocrin.

Why has Stocrin been approved?

The Committee for Medicinal Products for Human Use (CHMP) has determined that Stocrin's benefits are greater than its risks for the antiviral treatment of adults, adolescents and children 3 years of age or older with HIV in combination with other antiviral medicines. The committee noted that Stocrin has not been sufficiently studied in patients at an advanced stage of the disease (with CD4 cell counts less than 50 cells / mm3) or where treatment with protease inhibitors (another type of antiviral drug) is either concluded without success. The committee also noted that the information currently available is not sufficient to evaluate the efficacy of therapies based on the use of protease inhibitors used after the failure of therapy with Stocrin, although there is no evidence to support that in these patients protease inhibitors are not effective. The committee recommended that Stocrin be given marketing authorization.

More information on Stocrin:

On 28 May 1999, the European Commission issued a marketing authorization valid for Stocrin, valid throughout the European Union, to Merck Sharp & Dohme Limited. The marketing authorization was renewed on May 28, 2004 and May 28, 2009.

The full EPAR for Stocrin can be found here.

Last update of this summary: 05-2009.