Sustiva - efavirenz

What is Sustiva?

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

What is Sustiva used for?

Sustiva is an antiviral drug, indicated in combination with other antiviral drugs for the treatment of adults and children aged at least 3 years with human immunodeficiency virus type 1 (HIV-1), a virus that causes the syndrome of acquired immunodeficiency (AIDS).
The medicine can only be obtained with a prescription.

How is Sustiva used?

Sustiva therapy should be started by a physician experienced in the treatment of HIV infection. Sustiva should be given in combination with other antiviral medicines. It is recommended that Sustiva be taken on an empty stomach and without food, preferably at bedtime.
The recommended dose of Sustiva for adults is 600 mg once a day. In patients 3 to 17 years of age, the dose depends on body weight. Patients who are unable to swallow the capsules or tablets can take Sustiva oral solution. If the patient is unable to tolerate the oral solution, the possibility of mixing the contents of the capsules with a small amount of food (about two teaspoons) can be considered. The dose of Sustiva should be reduced for patients taking voriconazole (for the treatment of fungal infections). Patients taking rifampicin (an antibiotic) may need to take a higher dosage of Sustiva.
For further details, see the Summary of Product Characteristics (also attached to the EPAR).

How does Sustiva work?

Sustiva 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 the body's cells and produce more viruses. By inhibiting this enzyme, Sustiva, taken in combination with other antiviral drugs, reduces the amount of HIV in the blood, keeping it at a low level. Sustiva does not cure HIV infection or AIDS, but it can
delay the damage caused to the immune system and the onset of infections and diseases associated with AIDS.

How has Sustiva been studied?

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

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

Sustiva has also been studied in 57 children between the ages of 3 and 16, in combination with nelfinavir and other antiviral drugs.
In all of the above studies, the main measure of effectiveness was the number of patients with undetectable levels of HIV-1 in their blood (viral load) after 24 or 48 weeks of treatment.

What benefit has Sustiva shown during the studies?

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

1. the first study found that after 48 weeks, 67% of adults taking Sustiva in combination with zidovudine and lamivudine had a viral load of less than 400 copies / ml compared to 54% of patients treated with Sustiva and indinavir, and 45% of those treated with indinavir, lamivudine and zidovudine;
2. in the second study Sustiva in combination with nelfinavir gave better results than the combination without Sustiva 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 document that, after 24 weeks, a greater percentage of patients taking Sustiva had viral loads below 400 copies / ml compared to patients taking placebo.

Similar results were found in the study on children.

What is the risk associated with Sustiva?

The most common side effects seen with Sustiva (seen in more than 1 in 10 patients) are skin rashes. Sustiva can also involve nervous system symptoms such as dizziness, insomnia, sleepiness, difficulty concentrating and disturbed dream activity, and psychiatric disorders including severe depression, suicidal thoughts, suicide attempts and aggressive behavior, particularly in patients. with a history of mental illness. Taking Sustiva with food may cause an increase in the frequency of side effects. For the full list of side effects reported with Sustiva, see the package leaflet.
Sustiva must not be used in people who may be hypersensitive (allergic) to efavirenz or any of the other substances. It must not be given to patients with severe hepatic impairment or taking any of the following drugs:

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

Finally, precaution should be taken in the use of Sustiva in patients taking other medicines at the same time. For further details, see the package leaflet.
As with other HIV medicines, patients receiving Sustiva may be at risk for lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue), or immune reactivation syndrome (symptoms of infections caused by reactivation of the immune system). ). Patients with liver problems (including hepatitis B or C) may be at an increased risk of developing liver damage when treated with Sustiva.

Why has Sustiva been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Sustiva's benefits are greater than its risks in the antiviral treatment of HIV-infected adults, adolescents and children aged 3 years and over in combination with other antiviral medicines. The Committee noted that Sustiva has not been sufficiently studied in patients with advanced disease (with CD4 cell counts below 50 cells / mm3) or in whom treatment with protease inhibitors (another type of antiviral drug) has concluded unsuccessfully. The Committee also noted that currently available information is not sufficient to assess the efficacy of protease inhibitor-based therapies used after Sustiva therapy failure, although there is no evidence to support that in these patients protease inhibitors are not effective. The Committee recommended that Sustiva be given marketing authorization.

More information about Sustiva

On May 28, 1999, the European Commission issued a "Marketing Authorization" for Sustiva, valid throughout the European Union. The holder of the Marketing Authorization is the pharmaceutical company Bristol-Myers Squibb Pharma EEIG. L "marketing authorization" was renewed on May 28, 2004 and May 28, 2009.
For the full version of SUSTIVA's EPAR, click here.

Last update of this summary: 05-2009.

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