Tuesday, February 12, 2008

Sustiva drug

Drugs for you: Sustiva
Sustiva drug
Liz Highleyman
January 2004 (2005)


What are the different names for this drug?

Sustiva, Stocrin (outside the United States) - brands

efavirenz - the generic name

What kind of drug Sustiva?

Sustiva belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), also known as non-nucleoside analogues, or "no-nukes".


As Sustiva work?

In NNRTIs block reverse transcriptase, the HIV protein that it is necessary to make more copies. This may slow down HIV infection.

Who Sustiva approved for?

In Food and Drug (FDA) has approved Sustiva for use in combination with other HIV drugs for the treatment of HIV infection in adults and children over three years.
Sustiva drug


In FDA also granted preliminary approval of the overall formulation of Sustiva, although this version is not yet available in the United States

How to take Sustiva?

Sustiva comes in:
50 milligram (mg), 100 mg, 200 mg capsules
600 mg Tablets
The liquid formulation is currently being studied in children under three years of age, and through increased access to the program from the manufacturer

The normal dose for adults is one 600 mg tablet once a day.



Check with the child doctor dosage for children.



Sustiva is to be used with other drugs to treat HIV infection.



You can take Sustiva with food or on an empty stomach, but to take it on an empty stomach at bedtime reduces side effects. Sustiva should not be taken with a big fat meal because it increases the likelihood of side effects.



Talk with your doctor if you have liver problems or mental health issues (such as depression), or using street drugs or alcohol.



It may take two to three weeks to Sustiva be excluded from your body after you stop taking it. Careful planning must be a doctor if you stop taking the medication regime, which contains Sustiva, especially if you do not immediately switch to another drug treatment.

Why is it so important to take Sustiva exactly as prescribed?

Sustiva is one of the easiest drugs for HIV to take you to take one pill once a day. Once-daily medications handy, but more demanding because good adherence is crucial. The lack of a pass or doses can cause your blood drug levels fall too low, and resistance can develop. When a virus becomes resistant to HIV drugs, drugs that may stop working.

As Sustiva used?

Sustiva can be used if you are just starting treatment of HIV infection.
Studies have shown that Sustiva can be as effective or more effective than a protease inhibitor (PI) regimes in people treated for the first time (including those with high viral load).

Sustiva is an option to consider if you want "protease-sparing" drug regime (a regime that does not include PI).



Sustiva can be used if you were treated before, but it does not work well for people whose virus is already resistant to other NNRTIs: Rescriptor (delavirdine) and Viramune (nevirapine).



Your doctor may run resistance tests to help determine whether Sustiva is likely to work for you.



Sustiva seems to overcome the blood-brain barrier (which protects the brain and spinal cord), so that he may be able to fight HIV in the brain.

What happens if my virus develops resistance to Sustiva?

If the virus develops resistance to Sustiva he may stop working or not working, but for you. You can also benefit from other NNRTIs.

Sustiva whether interact with other drugs?

Sometimes taking more than one medication may cause drug interactions. Taking certain drugs (such as cholesterol-lowering drugs), with Sustiva may change the amount of one or both drugs in the blood. Your doctor may need to adjust the dose of your medicine, to avoid under-or overdosing.
Sustiva blood lowers the level of most PV. Your doctor will be necessary to increase the dosage of Crixivan (indinavir), Agenerase (amprenavir), Reyataz (atazanavir), Kaletra (lopinavir / ritonavir) and Lexiva (fosamprenavir)
Sustiva and Fortovase (saquinavir), or Invirase (saquinavir), should not be used together
Methadone doses may need to be increased if you are taking Sustiva
Sustiva drug
Sustiva reduces the effectiveness of birth control pills, so that alternative methods of birth control should be used.



Some medicines, including some sedatives, antihistamines, antibiotics, antifungals, migraine headache pain, acid reflux, and TB drugs should not be taken with Sustiva. In addition, you should not take St. John's wort, an herbal information on the supplement.



Sustiva plus EU Videx (didanosine or ddI), as well as Viread (tenofovir), should not be used in new patients with HIV therapy.



Be sure your doctor knows about all the medications you are taking (including information, prescription, street drugs and herbs), even if you only use them from time to time.



For more information and additional resources to check the interaction between specific drugs you are taking, see our information sheet on drug interactions.

Sustiva told the FDA label change

In Sustiva (efavirenz) insert package has been recently updated the Federal Drug (FDA), drug-drug interactions include information declare Sustiva should not be administered concurrently with bepridil (which is a calcium channel blocker), pimozide (which for some exemptions, and mood disorders) and standard doses of voriconazole (which is a very popular anti-fungal treatment). In FDA stresses that SUSTIVA tablets should not be disturbed.

What are the side effects?

Sustiva side effects tend to occur during the first two to four weeks of treatment, and generally improve as your body adjusts to the medication. In some cases, side effects can last longer than the first month.

Sustiva drug

Many of the side effects associated with Sustiva affects the central nervous system (CNS):
Dizziness
Insomnia (sleep problems)
Drowsiness
The problem of concentration
Vivid dreams
Changes in mood
Depression

Other side effects include:
Skin rash (rash may be a serious problem in some children)
Headaches
Nausea
Diarrhea
Fatigue (unusual fatigue)

Many people believe that they can cope with the side effects better if they are taking Sustiva at bedtime. Your doctor can help you manage the side effects of Sustiva by prescription drugs for the treatment of insomnia and anxiety. If the side effects will not disappear or become unbearable, call your doctor for advice. Do not simply stop taking the medicine.



More serious side effects:
Although rare, some people have clinical depression, paranoia and suicidal thoughts
Sustiva may cause less rash NNRTI than other drugs, but in rare cases, this has led to a life-threatening hypersensitivity reaction (Stevens-Johnson syndrome). Symptoms may include severe rashes, blisters, mouth ulcers, tumors, high fever and weakness
Liver toxicity: this may be indicated by elevated liver enzymes, or yellowing of the skin and eyes (jaundice)

Call your doctor immediately if you experience any of the more serious side effects.

What specific research has been done on women and Sustiva?

Sustiva has been examined in many women. Study pharmacokinetics Sustiva (as a drug-processing body), showed that the drug behaves in the same way women and men, but some studies show that Sustiva can reach higher levels in women. The drug manufacturer does not recommend any adjustments based on the doses of sex and weight.



Study DMP266-006 compared Retrovir (zidovudine, or AZT), and Epivir (lamivudine or 3TC), and Sustiva for Retrovir plus Epivir Crixivan plus Sustiva plus Crixivan to people who have not taken protease inhibitors, or NNRTIs before. The study included 17 per cent women, or about 215 women from the 1266 total participants.



After 48 weeks, more people taking Retrovir plus Epivir plus Sustiva was undetectable viral load than those who either Retrovir Epivir plus plus plus Sustiva Crixivan or Crixivan. More people in treatment Crixivan groups stopped because of side effects (although more people in the Sustiva group developed rashes or nervous system side effects). At 72 weeks, plus Retrovir Epivir plus Sustiva have worked better, but for three years, the rate of treatment failure in the Sustiva and Crixivan groups were similar.



The study ACTG 364, compared with Sustiva Viracept (nelfinavir) for Sustiva Viracept, as well as treatment and experienced people who are also nucleoside reverse transcriptase inhibitors (NRTIs). This trial included 12 per cent women, or about 23 women from a total of 196 participants. In this study, people taking Viracept plus Sustiva plus NRTIs or Sustiva plus NRTIs are more likely to achieve undetectable viral load than those taking Viracept plus NRTIs.



DMP-020 Study found that Sustiva plus Crixivan plus NRTIs worked better than Crixivan plus NRTIs without Sustiva. This process included about 17 per cent women, or 55 women from a total of 327 participants.



Study AI424-034 compared Retrovir plus Epivir plus Sustiva to Retrovir plus Epivir plus Reyataz in people who do not use HIV medicines before. The study included 35 per cent of women, or about 280 women from a total of 805 participants. The study Sustiva and Reyataz works equally well for HIV, but not Reyataz increased blood fat levels possible Sustiva.



ACTG 384, a large study comparing six different combinations of drugs, it was found that Retrovir plus Epivir plus Sustiva was the first one of the best schemes in terms of effectiveness and side effects.



In the 2NN study compared Zerit (stavudine, or d4T), as well as Epivir plus Sustiva compared Zerit plus Epivir plus Viramune to Zerit Epivir plus plus plus Sustiva Viramune people who had not taken HIV drugs before. This trial included 37 per cent of women, or about 449 women from the 1216 total participants.



The study, Sustiva and Viramune worked about equally well in general but Sustiva how to work better in people with high viral loads. People who occupy and Sustiva Viramune did worse than those who had only one NNRTI, as a treatment stopped because of side effects.



The study ACTG 5095 found that the drug circuits containing Sustiva worked better than all-NRTI plus Retrovir combination of Epivir plus Ziagen (abacavir), the three drugs in combination pill Trizivir. The study included 19 per cent, or about 218 women from the 1147 total participants.



A number of studies looked at people who move from PV to NNRTIs (for example, a study DMP266-049, including 10 per cent women, or about 22 women from a total of 226 participants). In general, these studies have shown that people who move from PI to Sustiva have similar or better response to treatment, as well as raising HDL ( "good") cholesterol, lower levels of LDL ( "bad") cholesterol and lower levels of triglycerides, that can protect against heart disease.



In terms of side effects, studies show that Sustiva can cause a skin rash or nervous system side effects. The study DMP266-006 (described above), 34 percent of participants taking Sustiva developed a rash, and 58 percent developed nervous system side effects. These side effects were most likely during the first month of treatment. Research does not seem to indicate that women taking Sustiva experience any more side effects than men. But we know that in general mood, depression and disorders more often in women and require further research on the nervous system side effects in women with this therapy.

What about pregnancy?

Studies have shown that pregnant women who use HIV drugs can significantly reduce the risk of transmission of HIV to their babies. There was no formal studies on the use of Sustiva during pregnancy. However, Sustiva has recently been linked to birth defects in humans resulting in FDA recommend Sustiva not be used during pregnancy. Because of this, pregnant women should not use Sustiva, and women who take the drug should use effective birth control. (Sustiva reduces the effectiveness of birth control pills, so that alternative methods of birth control should be used.)



Check with a doctor about the best treatment options for you and your child, if you are thinking to get pregnant.



Click here to learn more about pregnancy.

Are there any special considerations?

Testing for drugs

Sustiva could lead to a false positive result, if you get a drug test for marijuana.

Immune conversion syndrome

People who are beginning to treat HIV infection for the first time might be immunodeficiency syndrome or Restore IRS (also called Immune Restoration Inflammatory Syndrome, or IRIS). IRS may occur as a result of obtaining the immune system stronger, and in response to the HIV-related such as Mycobacterium avium infection (MAC), cytomegalovirus (CMV), Pneumocystis jirovecii pneumonia (PCP), and tuberculosis (TB). People may treat these infections in the past or do not even know they have them. If you notice any unusual symptoms shortly after the start of HIV drugs for the first time, let your doctor know immediately, so you can be evaluated and, if necessary, treatment.

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