Intelence™ – brand name

etravirine – generic name

Intelence belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), also known as non-nucleoside analogs or “non-nukes.”

Intelence and the other NNRTIs work by blocking reverse transcriptase, a protein that HIV needs to make more copies of itself. This may slow down HIV disease.

The Food and Drug Administration (FDA) has approved Intelence for use in combination with other HIV drugs for HIV+ adults who:

• Have failed treatment with other HIV drugs
• Have HIV that is resistant to another NNRTI and other HIV drugs
  

Intelence is not approved for people starting treatment for the first time.

The normal dose of Intelence is 200 mg (two 100 mg tablets) twice daily following a meal. The most convenient times to take Intelence are usually after breakfast and after dinner.

If you are unable to swallow the Intelence tablets whole, you can drop them in a glass of water and let them break apart (dissolve). Stir the water and tablets well and drink the whole glass as soon as the mixture turns a milky color. Then swirl a small amount of water in the glass and drink this to get any part of the tablets that may have been left behind. Repeat until you have taken the entire dose.

Intelence must be used in combination with other HIV medications.

Tell your doctor if you have liver problems. Intelence should be used with caution in people with severe liver problems.

As with all HIV drugs, it is important to take Intelence as prescribed by your health care provider. Missing or skipping doses can cause blood levels of Intelence to fall too low and the virus can become resistant to it. This may cause Intelence and the other HIV drugs you are taking to stop working.

If you miss a dose of Intelence, and you remember within six hours, you should take it as soon as possible (following a meal). Then take the next dose at the regularly-scheduled time. However, if you realize you have missed a dose more than six hours later, skip it and take the next dose at the regularly-scheduled time (following a meal).

Intelence, combined with other HIV drugs, can be used by people who have taken HIV drugs before and have HIV that is resistant to other HIV drugs. Intelence may be a good choice for people who are resistant to the other NNRTIs.

Intelence works best when it is combined with at least one other active HIV drug (a drug that their virus does not have resistance to). In people who have HIV that is resistant to other NNRTIs, Intelence should not be taken only with nucleoside/tide reverse transcriptase inhibitors (NRTIs or “nukes”).

You and your health care provider should use resistance testing and your treatment history to help guide the use of Intelence and to determine which drugs will work best for you.

If your virus develops resistance to Intelence, the drug may stop working or may not work as well for you.

Sometimes taking more than one medication can cause drug interactions. This can lead to the drugs not working as well or an increased risk of side effects.

Intelence can interact with many other medications used to treat HIV, HIV-related complications, and other diseases. Taking Intelence with these drugs can change the amount of each drug in your blood. Your health care provider may need to either adjust the doses of your drugs to avoid under- or overdosing or change the drugs you currently take.

Intelence should not be combined with:

• Reyataz (atazanavir) plus Norvir (ritonavir)
• Lexiva (fosamprenavir) plus Norvir
• Aptivus (tipranavir) plus Norvir
• Full dose Norvir
• Any protease inhibitors given without a boosting dose of Norvir
• Any of the other approved NNRTIs
• Products containing the herb St. John’s Wort

Intelence also interacts with Kaletra and drugs to treat bacterial infections including TB and MAC, fungal infections, erectile dysfunction, heart problems, convulsions, or high cholesterol.

There do no appear to be drug interactions between Intelence and methadone or birth control pills.

This is not a complete list of medications that interact with Intelence. Because there are so many possible drug interactions with Intelence, it is very important to go over all your medications with your health care provider. Be sure your health care provider knows about all the medications you are taking (including over-the-counter, prescriptions, street drugs, and herbs), even if you only use them occasionally.

For more information and additional resources to check interactions between the particular drugs you are taking, see our info sheet on drug interactions or go to:

http://www.hiv-druginteractions.org
OR
http://hivinsite.ucsf.edu/insite?page=ar-00-02

Intelence is generally well tolerated. It is possible that unexpected long-term side effects could show up later.

If you do experience any side effects from Intelence, they are likely to be temporary and go away as your body adjusts to the medication. If you experience any of the side effects listed below, call your doctor for advice. Do not just stop taking your medication.

• Skin rash
• Diarrhea
• Nausea
• Abdominal pain
• Vomiting
• Tiredness
• Tingling or pain in hands or feet
• Numbness
• Headache
• High blood pressure
• Changes in body shape or body fat (the exact causes are not known, but may include HIV and/or HIV drugs)
  

More serious side effects:

• Severe skin rashes (Stevens-Johnson syndrome) or rashes with an allergic reaction (hypersensitivity reactions): Sometimes these allergic reactions can affect body organs, like the liver. These allergic reactions usually include a rash with other symptoms such as fever, general ill feeling, extreme tiredness, muscle or joint aches, blisters, mouth sores, irritated eyes, facial swelling and/or signs and symptoms of liver problems (yellowing of your skin or whites of your eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea, vomiting, loss of appetite, or pain, aching or sensitivity on your right side below your ribs). If you get a rash, contact your health care provider right away to determine if you should stop taking Intelence.
  

If you are experiencing persistent, unusual, or serious side effects, call your health care provider right away.

A study called GRACE (Gender, Race and Clinical Experience) looked at whether there were gender and race differences in response to treatment with various HIV drugs including Prezista and Intelence. The GRACE study showed that after 48 weeks of treatment, there were no significant differences in effectiveness between women and men who took Intelence.

Intelence was well-tolerated overall, and there was little difference between women and men for most adverse events. Women, however, were more likely to experience nausea, while men more often had elevated triglyceride levels.

It is very important for women to get involved in HIV drug research and clinical trials. Historically, women's health issues have not been thoroughly researched in HIV+ women. This needs to change – our bodies are different from men’s bodies, and our reactions to medications can be different, too. You can help by getting involved and participating. If you are interested in learning about or enrolling in clinical trials, see The Well Project info sheets on clinical trials.

Studies have shown that pregnant women who use HIV drugs can greatly reduce the risk of passing HIV on to their babies. However, there have been no formal studies on the use of Intelence during pregnancy. Intelence should be used in pregnant women only if the possible benefit outweighs the potential risk to the baby.

An Antiretroviral Pregnancy Registry has been established to collect information on pregnant women who take HIV drugs, including Intelence. If you are pregnant and taking Intelence or other HIV drugs, your health care provider can register you by calling 1-800-258-4263 or going to www.apregistry.com.

It is not known whether Intelence passes into breast milk. HIV+ women should not breast-feed because their babies could be infected with HIV through the breast milk.

Check with your health care provider about the best treatment options for you and your baby if you are thinking of getting pregnant.

Click this link for more information about pregnancy.

People who are starting HIV treatment for the first time may develop Immune Reconstitution Syndrome or IRS (also called Immune Reconstitution Inflammatory Syndrome or IRIS). IRS can happen as a result of the immune system getting stronger and responding to an HIV-related infection such as Mycobacterium avium infection (MAC), cytomegalovirus (CMV), Pneumocystis jirovecii pneumonia (PCP), or tuberculosis (TB). People may have been treated for these infections in the past or not even know they have them. If you notice any unusual symptoms soon after starting HIV drugs, let your health care provider know right away so you can be evaluated and, if necessary, treated.