Fusion inhibitors (FIs)

BACKGROUND

Fusion inhibitors (FIs) are a type of antiretroviral medication that helps prevent HIV (human immunodeficiency virus) from entering and infecting human cells. Although they are not curative, these drugs have shown to effectively slow the replication of the virus in the body when taken in combination with other antiretrovirals.

Currently, the U.S. Food and Drug Administration (FDA) has approved one fusion inhibitor, enfuvirtide (Fuzeon©), also called T-20. Clinical trials have demonstrated that enfuvirtide-based therapy is an effective treatment for patients who have taken other types of antiretrovirals in the past. Enfuvirtide should not be taken in patients who have never received antiretroviral drugs before.

HIV primarily targets the body's CD4 T-cells, which are white blood cells that help coordinate the immune system's response to infection and disease. Therefore, HIV patients are vulnerable to opportunistic infections. These infections occur in patients who have weakened immune systems.

Antiretrovirals are able to suppress HIV, which boosts the patient's immune system. These drugs have also shown to dramatically slow the progression of opportunistic infections. These infections can be potentially fatal and may lead to the development of AIDS, if not properly treated.

HIV patients typically receive a combination of antiretroviral drugs because a single patient may have several different strains (types) of the virus circulating in the blood. The different strains of the virus may respond differently to specific types of drugs. Therefore, highly active antiretroviral therapy (HAART), which is a combination of drugs from at least two different classes, is recommended. There are four major classes of antiretrovirals: fusion inhibitors, protease inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), and non-nucleoside reverse transcriptase inhibitors (NNRTIs). Each drug class disrupts different stages of HIV's life cycle.

FUNCTIONS

Enfuvirtide (Fuzeon©), also called T-20, is the only fusion inhibitor available for the treatment of HIV. This antiretroviral prevents HIV from fusing with outer surface (cell membrane) of the host's cells. When the virus cannot penetrate the cell membrane, it is unable to infect and destroy the patient's cells.

Fusion inhibitors, first introduced in 2003, are taken in combination with other antiretroviral drugs to suppress the replication of HIV. When the virus is suppressed, the body's immune system is restored and the patient is less susceptible to infections and diseases.

Some HIV patients who are receiving a combination of antiretrovirals may achieve undetectable levels of the virus. This does not mean that the patient is cured. It simply means that the number of viral particles in the blood (viral load) is lower than the test can detect.

DOSING

Enfuvirtide (Fuzeon©) is currently the only fusion inhibitor that has been approved by the U.S. Food and Drug Administration (FDA). It was approved on March 13, 2003 for the treatment of HIV in adults and children who are six years old or older. In general, children only receive this medication if they do not respond to other types of antiretrovirals. Enfuvirtide should not be taken by patients who have never received antiretroviral drugs before.

Enfuvirtide is available as a powder that is mixed with sterile water and injected with a needle-free device under the skin. A patient receives the first dose of enfuvirtide in a healthcare provider's office. The healthcare provider then teaches the patient how to administer the medication. Adults should be trained to administer the drug to children who are unable to do it themselves.

Patients should not use the same injection site every time a dose is administered. Instead, it is recommended that patients alternate injecting the drug into the abdomen, upper arm, and front of the thigh.

Adults typically take 90 milligrams of enfuvirtide (1milliter) twice daily. Children ages six to 16 typically take 2 milligrams twice daily. Pediatric doses should not exceed 90 milligrams twice daily. Patients or their caretakers should always take or administer medications exactly as prescribed.

SIDE EFFECTS

Common side effects: The most common side effect associated with enfuvirtide is a skin rash where the medication was administered. It is estimated that up to 98% of patients experience some sort of skin reaction, which may cause bruising, cysts, itching, bumps, pain, and redness.

Other common side effects include cough, headache, pain or tenderness around the eyes and cheekbones, shortness of breath, wheezing, bad taste in the mouth, flu-like illness, fatigue, herpes simplex infection, loss of appetite, weight loss, muscle pain, nervousness, sinus problems, enlarged lymph nodes, difficulty breathing, runny or stuffy nose, tightness of the chest, dizziness, as well as burning, numbness, tingling, or pain in the arms, legs, hands, or feet. These side effects generally subside or disappear as treatment is continued.

Less common side effects: Less common side effects include bloating, chills, constipation, darkened urine, dry or itchy eyes, excessive tearing, eye discharge, rapid heartbeat, fever, indigestion, stomach pain, loss of appetite, swelling of the eye, vomiting, jaundice (yellowing of the eyes or skin), as well as itching, swelling, or warmth near the injection site.

Serious side effects: Severe allergic reactions have been reported with the use of enfuvirtide. These side effects may include chills, fever, nausea and vomiting, kidney problems, low blood pressure, paralysis, severe rash, dizziness, loss of consciousness, and difficulty breathing. Patients who experience any of these symptoms should seek immediate medical treatment because severe drug reactions may be fatal.

Severe infections at injection sites have also been reported.

Some patients who use needle-free devices to administer enfuvirtide have experienced nerve pain lasting up to six months, as well as bruising and internal bleeding. Patients should tell their healthcare providers if they have experienced any of these side effects.

In clinical trials, patients who took enfuvirtide were more likely to develop bacterial pneumonia than patients who took an inactive treatment (placebo). It remains unknown if enfuvirtide increases the risk of pneumonia, but patients should consult their healthcare providers if they experience symptoms of pneumonia including chills, high fever, sweating, chest pain, and cough that produces thick phlegm.

INTERACTIONS

Patients should tell their healthcare providers if they are taking any other drugs (prescription or over-the-counter), herbs, or supplements because they may interact with treatment.

Currently, no interactions have been reported in clinical trials.

PRECAUTIONS

Allergies: Patients should tell their healthcare providers if they have a history of allergic reactions to enfuvirtide. There have been reports of severe allergic reactions to enfuvirtide. Symptoms of a severe allergic reaction may include difficulty breathing, hives, chest pain, nausea, low blood pressure, or loss of consciousness. Patients who develop these symptoms should seek immediate medical treatment.

Co-existing medical conditions: Patients should tell their healthcare providers if they have any other medical conditions because they may increase the risk of developing serious side effects associated with enfuvirtide. Patients should tell their healthcare providers if they smoke, inject illegal drugs (such as cocaine and heroin), or have a family history of lung disease because they may have an increased risk of developing pneumonia.

Pregnancy and breastfeeding: Enfuvirtide has not been studied in pregnant women. Although the drug has not shown to cause birth defects or other medical problems in animal studies, this drug should be use cautiously in patients who are pregnant, might be pregnant, or are thinking about becoming pregnant. Patients should discuss the potential health risks and benefits of treatment with their healthcare providers.

It remains unknown whether enfuvirtide can pass into breast milk. However, HIV/AIDS patients should not breastfeed their babies because the virus may be transmitted through the breast milk.

Proper administration: Enfuvirtide should not be taken in patients who have never received antiretroviral drugs before.

The drug should be injected under the skin into the fatty layer beneath the surface. It is recommended that patients alternate injecting the drug into the abdomen, upper arm, and front of the thigh. Enfuvirtide should not be injected in areas where large nerves are close to the skin, such as the tops of the hands. The drug should not be injected into a vein or muscle. Enfuvirtide should not be injected into moles, scars, tattoos, burns, open cuts, blisters, or sores on the skin.

Patients should not share needles or other injection equipment with others.

Patients should not alter their doses or stop taking enfuvirtide without first consulting their healthcare providers.

Enfuvirtide may make some patients dizzy. Patients who feel dizzy or lightheaded after treatment should not drive, operate heavy machinery, or engage in potentially dangerous activities.

INTEGRATIVE THERAPIES

Note : Integrative therapies should not be used in place antiretroviral therapy. Patients should consult their healthcare providers before taking any herbs or supplements because they may interact with treatment.

Unclear or conflicting scientific evidence :

Aloe vera : Clear gel from the pulp of Aloe vera leaves has been used on the skin for thousands of years to treat wounds, skin infections, minor burns, and other skin conditions. Although aloe has been suggested as a possible treatment for HIV, further research is needed before a firm conclusion can be made.

Avoid if allergic to aloe or other plants of the Liliaceae family (garlic, onions, and tulips). Avoid injecting aloe. Do not apply to open skin, surgical wounds, or pressure ulcers. Avoid taking by mouth with diarrhea, bowel blockage, intestinal diseases, bloody stools, or hepatitis. Avoid with a history of irregular heartbeat (arrhythmia), electrolyte imbalances, diabetes, heart disease, or kidney disease. Avoid taking by mouth if pregnant or breastfeeding.

Antineoplastons : Antinioplastons are substances found in human blood and urine. A small preliminary study reported increased energy and weight in patients with HIV, as well as a decreased number of opportunistic infections and increased CD4+ counts overall. These patients were treated with antineoplaston AS2-1. However, this evidence cannot be considered conclusive. Currently, there are drug therapy regimens available for HIV with clearly demonstrated effects (highly active anti-retroviral therapy. Patients with HIV are recommended to consult with their physicians about treatment options.

Avoid if allergic or hypersensitive to antineoplastons. Use cautiously with high medical or psychiatric risk. Use cautiously with an active infection due to a possible decrease in white blood cells. Use cautiously with high blood pressure, heart conditions, chronic obstructive pulmonary disease, liver disease/damage, or kidney disease/damage. Avoid if pregnant or breastfeeding.

Beta sitosterol : Beta-sitosterol is found in plant-based foods, such as fruits, vegetables, soybeans, breads, peanuts, and peanut products. It is also found in bourbon and oils (such as olive oil, flaxseed and tuna). Due to data that suggest immune modulating effects of beta-sitosterol and beta-sitosterol glucoside, these sterols have been studied in combination in the treatment of HIV. Larger populations of patients with HIV should be evaluated in randomized controlled trials to draw any conclusions.

Avoid if allergic or hypersensitive to beta-sitosterol, beta-sitosterol glucoside, or pine. Use cautiously with asthma or breathing disorders, diabetes, primary biliary cirrhosis (destruction of the small bile duct in the liver), ileostomy, neurodegenerative disorders (like Parkinson's disease or Alzheimer's disease), diverticular disease (bulging of the colon), short bowel syndrome, celiac disease, and sitosterolemia. Use cautiously with a history of gallstones. Avoid if pregnant or breastfeeding.

Bitter melon : Laboratory studies have shown that a protein in bitter melon called MAP30 may have antiviral activity. However, this has not been studied in humans. Further research is needed before a firm conclusion can be made.

Avoid if allergic to bitter melon or members of the Curcurbitaceae (gourd or melon) family. Avoid ingesting bitter melon seeds. Avoid with glucose-6-phosphate dehydrogenase deficiency. Use cautiously with diabetes, glucose intolerance, or with hypoglycemic agents due to the risk of hypoglycemia. Avoid if pregnant or breastfeeding.

Chiropractic : Chiropractic care focuses on how the relationship between musculoskeletal structure (mainly the spine) and bodily function (mainly nervous system) affects health. There is not enough reliable scientific evidence to conclude the effects of chiropractic techniques on CD4 count or quality of life in patients with HIV/AIDS.

Use extra caution during cervical adjustments. Use cautiously with acute arthritis, conditions that cause decreased bone mineralization, brittle bone disease, bone softening conditions, bleeding disorders, or migraines. Use cautiously with the risk of tumors or cancers. Avoid with symptoms of vertebrobasilar vascular insufficiency, aneurysms, unstable spondylolisthesis, or arthritis. Avoid with agents that increase the risk of bleeding. Avoid in areas of para-spinal tissue after surgery. Avoid if pregnant or breastfeeding due to a lack of scientific data.

Coenzyme Q10 : Coenzyme Q10 (CoQ10) is produced by the body and it is necessary for basic functioning of cells. CoQ10 levels decrease with age. There is limited evidence that natural levels of CoQ10 in the body may be reduced in people with HIV/AIDS. There is no reliable scientific research showing that CoQ10 supplements have any effect on this disease.

There are currently no documented cases of allergy associated with Coenzyme Q10 supplements, although rash and itching have rarely been reported. Stop use two weeks before surgery/dental/diagnostic procedures with bleeding risk and do not use immediately after these procedures. Use cautiously with history of blood clots, diabetes, high blood pressure, heart attack, or stroke. Use cautiously with anticoagulants (blood thinners), antiplatelet drugs, blood pressure drugs, blood sugar drugs, cholesterol drugs, or thyroid drugs. Avoid if pregnant or breastfeeding.

DHEA : DHEA (Dehydroepiandrosterone) is a hormone that is secreted by the adrenal glands. Although some studies suggest that DHEA supplementation may be beneficial in patents with HIV, results from different studies do not agree with each other. There is currently not enough scientific evidence to recommend DHEA for this condition, and other therapies are more proven in this area.

Avoid if allergic to DHEA. Avoid with a history of seizures. Use cautiously with adrenal or thyroid disorders. Use cautiously if taking anticoagulants or drugs, herbs, or supplements for diabetes, heart disease, seizures, or stroke. Stop use two weeks before surgery/dental/diagnostic procedures with bleeding risk, and do not use immediately after these procedures. Avoid if pregnant or breastfeeding.

Flaxseed : Flaxseed and flaxseed oil/linseed oil are rich sources of the essential fatty acid alpha-linolenic acid (omega-6). While flaxseed has been used to treat HIV, no strong evidence supports its use and no recommendation can be made without further research.

Flaxseed has been well tolerated in studies for up to four months. Avoid if allergic to flaxseed, flaxseed oil, or other plants of the Linaceae family. Avoid with prostrate cancer, breast cancer, uterine cancer, or endometriosis. Avoid ingestion of immature flaxseed pods. Avoid large amounts of flaxseed by mouth and mix plenty of water or liquid. Avoid flaxseed (not flaxseed oil) with history of esophageal stricture, ileus, gastrointestinal stricture, or bowel obstruction. Avoid with history of acute or chronic diarrhea, irritable bowel syndrome (IBS), diverticulitis, or inflammatory bowel disease (IBD). Avoid topical flaxseed in open wounds or abraded skin surfaces. Use cautiously with history of a bleeding disorder or with drugs that increase the risk of bleeding (such as anticoagulants and non-steroidal anti-inflammatories). Use cautiously with high triglyceride levels, diabetes, mania, seizures, or asthma. Avoid if pregnant or breastfeeding.

Healing Touch : Healing touch (HT) is a combination of hands-on and off-body techniques to influence the flow of energy through a person's biofield. Data from small preliminary studies are insufficient to support any recommendations for or against use of HT in HIV/AIDS. Studies of better design are needed before any conclusions can be reached.

HT should not be regarded as a substitute for established medical treatments. Use cautiously if pregnant or breastfeeding.

L-carnitine : L-carnitine may be beneficial in AIDS treatment by increasing proliferation of mononuclear cells and increasing CD4 counts. Additional study is needed to make a firm recommendation

Avoid with known allergy or hypersensitivity to carnitine. Use cautiously with peripheral vascular disease, high blood pressure, alcohol-induced liver cirrhosis, and diabetes. Use cautiously in low birth weight infants and individuals on hemodialysis. Use cautiously if taking anticoagulants (blood thinners), beta-blockers, or calcium channel blockers. Avoid if pregnant or breastfeeding.

Meditation : Various forms of meditation have been practiced for thousands of years throughout the world with many techniques originating in Eastern religious practices. A common goal is to attain a state of "thoughtless awareness" of sensations and mental activities occurring at the present moment. More studies are needed to establish how meditation may be useful as an adjunctive therapy in HIV/AIDS patients.

Use cautiously with underlying mental illnesses. People with psychiatric disorders should consult with their primary mental healthcare professionals before starting a program of meditation and they should explore how meditation may or may not fit in with their current treatment plans. Avoid with risk of seizures. The practice of meditation should not delay the time to diagnosis or treatment with more proven techniques or therapies and it should not be used as the sole approach to illnesses.

Melatonin : Melatonin is a neurohormone produced in the brain. There is a lack of well-designed scientific evidence to recommend for or against the use of melatonin as a treatment for AIDS. Melatonin should not be used in place of more proven therapies, and patients with HIV/AIDS should be treated under the supervision of their healthcare professionals.

Based on available studies and clinical use, melatonin is generally regarded as safe in recommended doses for short-term use. There are rare reports of allergic skin reactions after taking melatonin by mouth. Use cautiously with bleeding disorders, seizure disorders, or if taking drugs that increase the risk of bleeding.

Mistletoe : Once considered a sacred herb in Celtic tradition, mistletoe has been used for centuries for high blood pressure, epilepsy, exhaustion, anxiety, arthritis, vertigo (dizziness), and degenerative inflammation of the joints. Treatment of HIV patients with mistletoe has been done in Europe since the beginning of the AIDS epidemic. Treatment seems to be tolerable with minimal side effects reported. Mistletoe may assist in inhibiting disease progression. However, not all mistletoe preparations have shown equal effects. Further study is needed before a firm conclusion can be made.

Avoid if allergic or hypersensitive to mistletoe or to any of its constituents. Anaphylactic reactions (life threatening, shock) have been described after injections of mistletoe. Avoid with acute, highly febrile, inflammatory disease, thyroid disorders, seizure disorders, or heart disease. Use cautiously with diabetes, glaucoma, or with cholinergics.

Prayer : Prayer can be defined as a "reverent petition," the act of asking for something while aiming to connect with God or another object of worship. Limited study of prayer in patients with AIDS reports fewer new AIDS-related illnesses and hospitalizations. However, due to methodological problems, these results cannot be considered conclusive.

Prayer is not recommended as the sole treatment approach for potentially serious medical conditions and it should not delay the time it takes to consult with a healthcare professional or receive established therapies. Sometimes religious beliefs come into conflict with standard medical approaches and require an open dialog between patients and caregivers.

Psychotherapy : Psychotherapy is an interactive process between a person and a qualified mental health professional. The patient will explore thoughts, feelings, and behaviors to help with problem solving. Psychotherapy, especially supportive psychotherapy, may reduce depression in HIV-positive patients. It may also help with treating substance abuse when used in combination with prescription medicine. Supportive-expressive group therapy may also have concomitant improvements in CD4 cell count and viral load. More research is needed in this area, especially to determine the best type of psychotherapy.

Psychotherapy cannot always fix mental or emotional conditions. Psychiatric drugs are sometimes needed. In some cases, symptoms may get worse if the proper medication is not taken. Not all therapists are qualified to work with all problems. Use cautiously with serious mental illness and medical conditions because some forms of psychotherapy may stir up strong emotional feelings and expression.

Relaxation therapy : Relaxation techniques include behavioral therapeutic approaches that differ widely in philosophy, methodology, and practice. Mental health and quality-of-life improvements have been seen in preliminary studies of HIV/AIDS patients. These findings suggest the need for further, well-controlled research.

Avoid with psychiatric disorders like schizophrenia/psychosis. Jacobson relaxation (flexing specific muscles, holding that position, then relaxing the muscles) should be used cautiously with illnesses like heart disease, high blood pressure, or musculoskeletal injury. Relaxation therapy is not recommended as the sole treatment approach for potentially serious medical conditions and it should not delay the time to diagnosis or treatment with more proven techniques.

Selenium : Selenium is a mineral found in soil, water, and some foods. Selenium supplementation has been studied in HIV/AIDS patients and some reports associate low selenium levels with complications such as cardiomyopathy. It remains unclear if selenium supplementation is beneficial in patients with HIV, particularly during antiretroviral therapy.

Avoid if allergic or sensitive to products containing selenium. Avoid with history of nonmelanoma skin cancer. Selenium is generally regarded as safe for pregnant or breastfeeding women. However, animal research reports that large doses of selenium may lead to birth defects.

Shiitake : Shiitake mushrooms were originally grown on natural oak logs found in Japan. Today, they are available in the United States. These mushrooms are large, black-brown, and have an earthy rich flavor. Based on preliminary studies, lentinan may increase CD4 counts and may qualify in future multi-drug studies in HIV patients. Further well-designed studies are needed to confirm these results. Side effects have been reported and more proven therapies are recommended at this time.

Avoid if allergic or hypersensitive to shiitake mushrooms. Avoid if pregnant or breastfeeding.

Thymus extract : Thymus extracts for nutritional supplements are usually derived from young calves. Preliminary evidence found no improvement in HIV progression to AIDS or immunostimulation, although some immunological activity was noted in a non-randomized controlled trial. Additional study is needed in this area.

Avoid if allergic or hypersensitive to thymus extracts. Use bovine thymus extract supplements cautiously due to potential for exposure to the virus that causes "mad cow disease." Avoid use with an organ transplant or other forms of allografts or xenografts. Avoid if receiving immunosuppressive therapy or hormone therapy. Avoid with thymic tumors, myasthenia gravis (neuromuscular disorder), or untreated hypothyroidism. Avoid if pregnant or breastfeeding. Thymic extract increases human sperm motility and progression.

Traditional Chinese medicine (TCM) : Traditional Chinese medicine (TCM) is a broad term that refers to many different treatments and traditions of healing. They share a common heritage of technique or theory rooted in ancient Chinese philosophy (Taoism) that dates back over 5,000 years. TCM herbs are a popular complementary therapy in HIV/AIDS. However, study results conflict. More studies are needed before the potential benefits of TCM herbs in HIV/AIDS can be established.

Chinese herbs can be potent and may interact with other herbs, foods, or drugs. Consult a qualified healthcare professional before taking. There have been reports of manufactured or processed Chinese herbal products being tainted with toxins or heavy metal or not containing the listed ingredients. Herbal products should be purchased from reliable sources. Avoid ma huang, which is the active ingredient in ephedra. Avoid ginseng if pregnant or breastfeeding.

Turmeric : Turmeric is a perennial plant native to India and Indonesia and it is often used as a spice in cooking. Several laboratory studies suggest that curcumin, a component of turmeric, may have activity against HIV. However, reliable human studies are lacking in this area.

Avoid if allergic or hypersensitive to turmeric (curcumin), yellow food colorings, or plants belonging to the Curcuma or Zingiberaceae (ginger) families. Use cautiously with history of bleeding disorders, immune system deficiencies, liver disease, or gallstones. Use cautiously with blood-thinners (e.g. warfarin). Use cautiously if pregnant or breastfeeding.

Vitamin A : Vitamin A is a fat-soluble vitamin that is derived from two sources: retinoids and carotenoids. Retinoids are found in animal sources (such as the liver, kidney, eggs, and dairy products). Carotenoids are found in plants like dark or yellow vegetables and carrots. The role of vitamin A in the prevention, transmission, or treatment of HIV is controversial and not well established. A clear conclusion cannot be formed based on the available scientific research.

Avoid if allergic or hypersensitive to vitamin A. Vitamin A toxicity can occur if taken at high dosages. Use cautiously with liver disease or alcoholism. Smokers who consume alcohol and beta-carotene may have an increased risk for lung cancer or heart disease. Vitamin A appears safe in pregnant women if taken at recommended doses. Use cautiously if breastfeeding because the benefits or dangers to nursing infants are not clearly established.

Zinc : Zinc formulations have been used since ancient Egyptian times to enhance wound healing. Patients with HIV/AIDS, especially in those with low zinc levels, may benefit from zinc supplementation. Some low quality studies cite reduction in infections, enhanced weight gain, and immune system function, including increased CD4 and CD8 cells. However, other low quality studies conflict with these findings. Further research is needed before a conclusion can be drawn.

Zinc is generally considered safe when taken at the recommended dosages. Avoid zinc chloride since studies have not been done on its safety or effectiveness. While zinc appears safe during pregnancy in amounts lower than the established upper intake level, caution should be used since studies cannot rule out the possibility of harm to the fetus.

Fair negative scientific evidence :

Ozone therapy : Ozone molecules are composed of three oxygen atoms. Ozone exists high in the earth's atmosphere and absorbs radiation from the sun. Reports of using ozone for medicinal purposes date to the late 19th Century. Laboratory studies have shown HIV virus to be sensitive to ozone, but no high-quality human studies exist. A preliminary study measured the safety and effectiveness of ozone-treated blood in the treatment of HIV infection and immune disease. Ozone therapy was not shown to enhance immune activation or diminish HIV virus.

Autohemotherapy has been associated with transmission of viral hepatitis and with a possible case of dangerously lowered blood cell counts. Insufflation of the ear carries a risk of tympanic membrane ("ear drum") damage and colon insufflation may increase the risk of bowel rupture. Consult a qualified health professional before undergoing any ozone-related treatment

St. John's wort : St. John's wort is a perennial herb that grows up to 32 inches tall and is commonly found in many parts of the world, including eastern North America and the Pacific coast. Anti-viral effects of St. John's wort have been observed in laboratory studies, but were not found in one human study. Multiple reports of significant adverse effects and interactions with drugs used for HIV/AIDS, including protease inhibitors (PIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs), suggest that patients being treated for HIV/AIDS should avoid this herb. Therefore, there is evidence to recommend against using St. John's wort in the treatment of patients with HIV/AIDS.

Avoid if allergic or hypersensitive to plants in the Hypericaceae family. Rare allergic skin reactions like itchy rash have been reported. Avoid with immunosuppressant drugs (like cyclosporine, tacrolimus ,or myophenic acid). Avoid with non-nucleoside reverse transcriptase inhibitors or protease inhibitors. Avoid with organ transplants, suicidal symptoms, or before surgery. Use cautiously with history of thyroid disorders. Use cautiously with drugs that are broken down by the liver, with monoamine oxidase inhibitors (MAOI) or selective serotonin reuptake inhibitors (SSRIS), digoxin, or birth control pills. Use cautiously with diabetes or with history of mania, hypomania, or seasonal affective disorder. Avoid if pregnant or breastfeeding.

AUTHOR INFORMATION

This information has been edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

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