Pronunciation(s): VIH-rah-mune; nah-VAIR-ah-peen
|What is Viramune?
- Viramune is an HIV medication. It is in a category of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Viramune prevents HIV from entering the nucleus of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.
- Viramune, manufactured by Boehringer-Ingelheim, was approved by the U.S. Food and Drug Administration for the treatment of HIV in 1996.
- Viramune is available in standard immediate-release tablets, which is taken twice-daily, and in an extended-release formation called Viramune XR, which is taken once-daily.
- Viramune must be used in combination with other drugs to treat HIV. It is usually combined with two nucleoside analogues.
- Boehringer Ingelheim has established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Aptivus. To learn more about the PAP for Aptivus, call 800-556-8317. For those with private health insurance, BI has established a program to help cover up to $50 toward each monthly Viramune co-payment. To learn more about this co-pay program, visit www.viramune.com or ask your health care provider.
What is known about Viramune?
- Taking Viramune is a two-step process, because starting at the full dose increases the chance of developing a serious rash. For the first two weeks (14 days) of treatment, the dose is one 200mg immediate-release tablet taken once a day. Two weeks after starting treatment, the dose of Viramune is increased to 400mg each day: people may take either one 400mg Viramune XR tablet once a day or one 200mg tablet twice a day. Following this schedule—which you should do under your doctor's guidance—can reduce the chance of developing a rash or other side effects.
- The U.S. Food and Drug Administration (FDA) recommends that women with CD4 counts over 250 and men with CD4 counts over 400 should not take Viramune as their first antireflective (ARV) regimen unless the benefits outweigh the risks. This is because Viramune can lead to serious liver problems in people with higher CD4 counts who start Viramune for the first time. This is especially true in pregnant women with higher CD4 counts. People whose CD4 counts have significantly increased from taking another ARV regimen (to greater than 250 in women and 400 in men) may can safely switch to Viramune, however.
- You may take Viramune with water, milk, or soda. You may take Viramune either with or without foods.
- Researchers have found that Viramune passes easily into the brain. This is very important because HIV can infect brain cells. HIV drugs that pass through the brain's protective barrier—called the "blood-brain barrier"—may help prevent and/or treat conditions like AIDS-related dementia.
- Viramune can be given to children, using their size or their body weight to determine the dose. Most experts prefer to use body weight as the method for selecting a Viramune dose. To learn more about Viramune dosing for children, click here. A liquid solution of Viramune is available for babies and children, which is easier to give to young children than the adult tablets.
- For HIV-positive adults beginning HIV drug therapy for the first time, Viramune is listed as an "alternative" NNRTI option by the United States Department of Health and Human Services (DHHS) in its treatment guidelines. The NNRTI Sustiva (efavirenz) is listed as the "preferred" option. However, among HIV-positive pregnant women, Viramune is the only recommended NNRTI option (due to the possibility of birth defects, Sustiva should not be used during pregnancy). To learn more about when to start treatment and what to start with, click here.
- If your viral load becomes detectable while taking a drug regimen that contains Viramune, your doctor can order a drug-resistance test to see which drugs your virus are becoming less sensitive to.
- All of the currently available NNRTIs are affected by cross-resistance. This means that, if you've tried and failed a drug regimen in the past that contained either Sustiva (efavirenz) or Rescriptor (delavirdine), your virus might be resistant to Viramune. Similarly, if you take an HIV drug regimen that contains Viramune and your virus becomes resistant to the drug, your virus will most likely be resistant to the other NNRTIs. This is why it is very important to use drug-resistance testing to determine which drugs your virus is no longer responding to if you experience a rebound in your viral load while taking an HIV drug regimen. Fortunately, new NNRTIs that are active against HIV strains resistant to current NNRTIs are being developed.
- If you decide to stop taking a drug regimen that contains Viramune and do not immediately switch to another drug regimen, careful planning is needed. It can take two to three weeks for Viramune to be completely eliminated from the body, whereas it only takes other HIV drugs a few days to be completely eliminated. If you stop taking a drug regimen that contains Viramune—for example, Viramune and Combivir—and do not immediately switch to another regimen, this would be like taking Viramune without any other medications, which can quickly lead to drug resistance. In turn, if you plan to stop a drug regimen that contains Viramune and do not plan on immediately switching to a new regimen, it is best to stop the Viramune first, several days before you stop the other HIV drugs (for example, the Combivir). You should plan this out, with your healthcare provider, before stopping your drug regimen.
What about drug interactions?
- Viramune is broken down (metabolized) by the liver, like many medications used to treat HIV and AIDS. This means that Viramune can interact with other medications. Viramune can lower or raise the levels of other medications in the body. Similarly, other medications can lower or raise the levels of Viramune in the body. While many interactions are not a problem, some can cause your medications to be less effective or increase the risk of side effects.
- Tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies, such as St. John’s Wort. Bring all your medicines when you see a doctor, or make a list of their names, how much you take, and how often you take them. Your doctor can then tell you if you need to change the dosages of any of your medications.
- The following medications should not be taken while you are being treated with Viramune:
Antibiotics: Rifadin (rifampin) and Priftin (rifapentine).
Herbal Medications: St. John's wort
- All of the available nucleoside reverse transcriptase inhibitors can be combined safely with Viramune.
- Viramune can alter the blood levels of various protease inhibitors, with the blood levels of some being increased and others decreased. Viramune increases the blood levels of Prezista (darunavir), but no dosing recommendations for combining these drugs has been established. Viramune can lower the dose of Norvir (ritonavir)-boosted Reyataz (atazanavir), Norvir-boosted Lexiva (fosamprenavir) and Kaletra (lopinavir/ritonavir). For this reason, Kaletra and Norvir/Lexiva should be used twice-daily when they are combined with Viramune, while Norvir/Reyataz should not be combined with Viramune at all. The interaction between Viramune and Norvir-boosted Invirase (saquinavir) has not been established.
- Viramune can interact with some medications used to treat TB, MAC and other bacterial infections. Rifadin (rifampin) can decrease Viramune levels (Rifadin should not be used). Mycobutin (rifabutin) can also decrease Viramune levels (no dose change necessary). Viramune can also decrease Biaxin (clarithromycin) levels; similarly Biaxin can increase Viramune levels (an alternative to Biaxin is recommended).
- Viramune can interact with some medications used to treat thrush (candidiasis) and other fungal infections. Viramune can decrease Nizoral (ketoconazole) levels in the bloodstream. Similarly, Nizoral can increase Viramune levels in the bloodstream. Taking these two drugs together is not recommended. Diflucan (flucanazole) can significantly increase Viramune blood levels, so caution is warranted and people should watch carefully for the development of Viramune side effects.
- Viramune can interact with oral contraceptives/birth control pills (ethinyl estradiol). Viramune decreases the amount of ethinyl estradiol in the bloodstream, which can increase the risk of pregnancy. Alternative forms of contraception should be used.
- If you take methadone, Viramune can decrease the amount of it in your blood. This might cause you to experience withdrawal symptoms and may require that your doctor or your rehabilitation program increase your dose of methadone.
- Viramune may decrease the blood levels of a number of medications used to treat heart problems. These include heart-rythm medications such as Cordarone (amiodarone), Norpace (disopyramide) and Xylocaine (lidocaine). It also includes calcium-channel blockers such as Cardizem (diltiazem), Procardia (nifedipine) and Veralan (verapamil). Blood levels of Coumadin (warfarin), which is used to prevent blood clots can also be decreased. No dose adjustments are recommended, but providers should watch for symptoms that the heart medications are not working properly.
- Viramune may decrease blood levels of drugs used to treat seizures and other disorders. These include Tegretol (carbamazepine), Klonapin (clonazepam) and Zarontin (ethosuximide). No dose adjustments are recommended, but providers should watch for symptoms that the anti-seizure medications are not working properly.
- Viramune may decrease blood levels of drugs used to suppress the immune system (e.g. after transplantation, or to treat auto-immune disease such as psoriasis). These include Sandimmune (cyclosporin), Prograf (tacrolimus), Rapamune (sirolimus). No dose adjustments are recommended, but providers should watch for symptoms that the immune-suppressing drugs are not working properly.
- It is not yet known what effect Viramune has on blood levels of Viagra (sildenafil) or Levitra (vardenafil), two drugs used for erectile dysfunction.
What is known about side effects?
- Liver problems have been reported in HIV-positive people treated with Viramune. The greatest risk of liver problems is during the first six weeks of treatment. Liver problems are more likely to occur in women (including pregnant women) with CD4 cell counts greater than 250 at the time of starting HIV treatment for the first time. As for men, liver problems are more likely to occur if the CD4 cell count is above 400 at the time of starting HIV treatment for the first time. HIV-positive people should work with their doctors very carefully if they have CD4 cell counts above these levels and are planning on starting therapy for the first time with a drug regimen that contains Viramune.
- Because liver problems can be very serious, your doctor should make sure your liver is healthy—he or she can order simple blood tests to check for this—before you start taking Viramune. Your doctor should also test your blood frequently during the first three to four months of treatment.
- In rare cases, liver problems can be very serious and become life-threatening. Therefore, if you develop any of the following symptoms, call your doctor immediately: general ill feeling, tiredness, lack of appetite, yellowing of the skin or eyes, darkening of the urine, pale stools, liver tenderness.
- The most common side effect of Viramune is skin rash. In a small number of patients, rash has been serious and resulted in death. Therefore, if you develop a rash with any of the following symptoms, call your doctor immediately: general ill feeling, fever, muscle or joint aches, blisters, mouth sores, conjunctivitis (inflammation of the inner surface of the eyelids), swelling of the face, tiredness.
- If you must stop treatment with Viramune because you have these types of serious reactions, you must not take Viramune again.
Can pregnant women take Viramune?
- Viramune is classified by the FDA as a pregnancy category B drug. Pregnancy category B means that animal studies have failed to demonstrate a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. HIV-positive women who become pregnant should discuss the benefits and possible side effects of HIV treatment to help protect their babies from HIV (see our lesson called Family Planning, Pregnancy & HIV).
- Viramune has been shown to easily pass from a pregnant woman's bloodstream, through the placenta, into the baby's bloodstream. This is important, as it helps protect a baby from HIV in his or her mother's bloodstream, both while it is developing and at the time of birth.
- Viramune has been studied in clinical trials of HIV-positive pregnant women. In one study funded by the U.S. federal government (PACTG 250), single doses of Viramune were given to HIV-positive pregnant women prior to delivery and to their babies within three days of being born. Viramune did not cause any significant short-term or long-term side effects in either the mother or her baby.
- Results from another study (HIVNET 012) suggested that giving a single dose of Viramune to an HIV-positive pregnant woman immediately before birth—followed by a dose given to her newborn baby—reduces transmission rates by nearly 50%. This study was conducted in African women, many of whom did not receive adequate prenatal care. Because they are effective and cheap, single doses of Viramune are now being used in many clinics in poor countries to help reduce the risk of mother-to-infant HIV transmission.
In the United States and other industrialized nations where HIV drug treatment is widely available, the use of single-dose Viramune—without the use of other HIV treatments—is not recommended. This is because single-dose Viramune monotherapy can lead to rapid HIV resistance to Viramune. Using single-dose Viramune at the time of delivery, provided that other HIV medications have been used during pregnancy (and will continue to be used after the baby is born), is possible.
- More recently, a second study funded by the U.S. federal government (PACTG 316) concluded that HIV regimens that contain a combination of drugs—which may include Viramune—reduced the risk of transmission to 1.5%. In other words, only 3 out of every 200 HIV-positive pregnant women who take a combination of HIV drugs and have an undetectable viral load at the time of delivery will give birth to HIV-positive babies.
- Viramune can pass from a mother to her baby through breast milk. It is not known what effect this may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.
Who should not take Viramune?
- Do not take Viramune if you are allergic to Viramune or any of its ingredients.
- HIV medication is sometimes used to prevent infection in people who are HIV-negative, but who have been exposed to HIV. This is called post-exposure prophylaxis, or PEP. Viramune should not be used for PEP due to the risk of liver toxicity.
- Do not restart Viramune after you recover from serious liver or skin reactions which have occurred while taking this drug.
Where can I learn more about clinical trials of Viramune?
- If you would like to find out if you are eligible for any clinical trials that include Viramune, visit ClinicalTrials.gov, a site run by the U.S. National Institutes of Health. The site has information about all HIV-related clinical studies in the United States. For more info, you can call their toll-free number at 1-800-HIV-0440 (1-800-448-0440) or email firstname.lastname@example.org.