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• Hydroxyurea is approved as an antineoplastic. Antineoplastics are used to treat cancer. Hydroxyurea is used to treat melanoma (a type of skin cancer), chronic myelocytic leukemia (CML), cancer of the ovary, and primary squamous cell (skin) cancer of the head and neck.
   
• Hydroxyurea has also bee studied as a potential treatment for HIV infection. Although it is not approved by the U.S. Food and Drug Administration for this purpose, some HIV-positive people do use it, usually in combination with approved anti-HIV drugs. Because the use of hydroxyurea for the treatment of HIV infection is considered to be experimental, it is very important that you work closely with a healthcare provider familiar with the potential benefits and side effects of this drug. There are no official guidelines or recommendations regarding the use of hydroxyurea for the treatment of HIV infection.
   
•  If hydroxyurea is prescribed, it should be used carefully by HIV-positive people who have low T-cell counts (e.g., below 200 cells/mm3). Hydroxyurea can cause a decrease in the number of T-cells and can cause serious side effects in people with impaired immune systems.
   
•  Serious, even fatal, cases of pancreatitis (inflammation of the pancreas) have been reported in people who combined hydroxyurea with Videx® or Videx EC® (ddI). Notify your doctor immediately if you develop symptoms of pancreatitis including nausea, vomiting, diarrhea, abdominal pain. Avoid alcohol while you are taking hydroxyurea and Videx or Videx EC. Alcohol may increase the risk of damage to your pancreas.

What is already known about hydroxyurea?

• Unlike other drugs used to treat HIV, hydroxyurea does not attack the virus. Hydroxyurea targets the immune system, specifically T-cells.
   
• HIV infects T-cells. When HIV-infected T-cells attempt to divide – a normal function of T-cells – they end up producing thousands of new HIV viruses and releasing them into the body. Hydroxyurea stops T-cells from dividing. This is believed to reduce the amount of HIV produced by T-cells.
   
• Because hydroxyurea targets T-cells and not the virus, many researchers believe that resistance to this drug occurs very slowly, if at all. Most people who have been using hydroxyurea in clinical trials or under the care of their own doctors have not shown any signs of resistance to the drug.
   
• A safe and effective dose for hydroxyurea for the treatment of HIV has not been established or approved by the FDA. In clinical trials, the usual dose was 500mg twice a day (no more than 1,000mg a day).
   
• Clinical trials of hydroxyurea, in combination with other anti-HIV drugs, have produced conflicting results. In small studies combining hydroxyurea with Zerit® (d4T) and Videx® (ddI), there was noticeable anti-HIV activity. However, in a larger clinical trial, hydroxyurea was not associated with any additional benefits when combined with a regimen containing a protease inhibitor, Zerit, and Videx. What’s more, the study was stopped early because of a higher rate of side effects (e.g., pancreatitis, low white blood cell counts, low red blood cells, and peripheral neuropathy) in study volunteers who combined hydroxyurea with their other drugs.

What are the possible side effects of hydroxyurea?

•  The most serious side effects of hydroxyurea involve the blood, and may include severely low white blood cell counts (leukopenia, neutropenia), which can decrease your resistance to infections. Hydroxyurea can also cause severely low red blood cell counts (anemia) and/or severely low platelet counts (thrombocytopenia), which can can cause excessive bleeding.
   
• Inflammation of the pancreas (pancreatitis), which can be life-threatening, has been reported in HIV-positive people combining hydroxyurea with Videx.
   
•  It is very important that your doctor measure your blood counts regularly while you are taking hydroxyurea.
   
• In clinical trials using high doses of hydroxyurea for the treatment of sickle cell anemia and cancers, common side effects included hair loss, skin rash, fever, stomach and/or bowel disturbances, weight gain, bleeding, discolored nails.

Who should not take hydroxyurea?

•  Hydroxyurea is in the FDA pregnancy category D. This means that hydroxyurea will harm an unborn baby. Do not take this medication if you are pregnant or planning a pregnancy without first talking to your doctor.
   
•  It is not known whether hydroxyurea passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding.

What about drug interactions?

• Caution should be used when combining hydroxyurea with other medications known to cause bone-marrow toxicity, such as decreased white blood cells, decreased red blood cells, and decreased platelets. Many medications used to treat AIDS-related diseases and some anti-HIV medications can increase the risk of bone-marrow toxicity caused by hydroxyurea.

Where can I get more information?

• Your pharmacist has additional information about hydroxyurea written for health professionals that you may read.
   
• If you would like to find out if you are eligible for any clinical trials that include hydroxyurea, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
   
• Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have “health information specialists” you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

• Bevirimat is an anti-HIV medication. It is in a new category of HIV medicines known as maturation inhibitors.
   
• Bevirimat is a derivative of a Chinese herb called Syzigium claviflorum.
   
• Virus maturation is the process that occurs during the last stages of HIV reproduction, after the virus has been released from the infected cell. It involves the processing of viral proteins and is required for the virus to become infectious. By blocking, or inhibiting, the virus maturation process, new virus cannot go on to infect other cells in the body.
   
• Because bevirimat works differently than currently available anti-HIV drugs, it will likely be effective for HIV-positive people who are new to anti-HIV treatment or have failed other anti-HIV treatments in the past.
   
• Bevirimat will likely be used in combination with other anti-HIV drugs.

What is already known about bevirimat?

• Bevirimat will likely need to be taken once a day, by mouth. The correct dose of bevirimat, in adults and children, has not yet been determined. Though there have been challenges in making a tablet formulation of Bevirimat, current studies are using a tablet.
   
•  Like other drugs, bevirimat might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
   
• Bevirimat is currently in Phase II studies. Further studies are planned.

What about drug interactions?

• Because both bevirimat and Reyataz (atazanavir) are processed by the liver’s UGT system, there was concern that bevirimat may increase Reyataz blood levels and side effects. A small study showed that the blood levels of neither drug was affected when the two were taken together.
   
• Data on possible interactions between bevirimat and other drugs have not yet been reported. Studies to assess potential drug interactions are planned.

What is known about side effects?

• Not much is known about the side effects of bevirimat. In the phase IIa study discussed above, the main side effects included nausea and headache. One volunteer with a history of high blood pressure suffered a stroke, but investigators thought it was unrelated to the study treatment.
   
• More information about the side effect profile of bevirimat will be made available once larger phase II clinical trials are completed.

Who should not take bevirimat?

•  It is not known whether bevirimat will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
   
•  It is not known whether bevirimat passes into breast milk and what effect it 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.

Where can I learn more about clinical trials of bevirimat?

• If you would like to find out if you are eligible for any clinical trials that include bevirimat, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
   
• Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have “health information specialists” you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

What is elvitegravir?

• Elvitegravir is an experimental integrase inhibitor being developed by Gilead Sciences.
   
• After HIV’s genetic material is deposited inside a cell, its RNA must be converted (reverse transcribed) into DNA. A viral enzyme called integrase then helps to hide HIV’s DNA inside the cell’s DNA. Once this happens, the cell can begin producing genetic material for new viruses. Integrase inhibitors, such as elvitegravir, are designed to block the activity of the integrase enzyme and to prevent HIV DNA from entering healthy cell DNA.
   
• Elvitegravir will need to be used in combination with other drugs. Clinical trials will evaluate its effect in combination with other drugs, including those currently approved for the treatment of HIV.

What is already known about elvitegravir?

• The elvitegravir dose, to be explored in advanced Phase II and III clinical trials, will be 150mg once daily, combined with 100mg Norvir (ritonavir). Norvir is used to boost elvitegravir in the bloodstream, making it more effective against HIV.
   
•  Elvitegravir, especially when combined with Norvir, might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
   
• Elvitegravir holds promise for HIV-positive patients who have taken other anti-HIV drugs in the past. Because elvitegravir targets HIV differently than currently available drugs, chances are that most people living with the virus—regardless of their treatment history—will likely benefit from using elvitegravir.
   
• Phase II studies of elvitegravir in people who are treatment experienced have been completed. Phase III studies in treatment experienced patients are ongoing. A phase II study of elvitegravir in people who have never taken antiretroviral therapy is underway. This study will also be evaluated a boosting agent in place of Norvir, currently called GS9350.

What about drug interactions?

• Studies on potential interactions between elvitegravir and other drugs have not yet been reported, but are planned and ongoing.

What is known about side effects?

• Very little is known about the side effects of elvitegravir. However, in the 278-patient study, side effects after 16 weeks of treatment were similar in the elvitegravir groups and the control group, meaning that no additional short-term side effects associated with elvitegravir use were documented.
   
• Additional studies evaluating the short- and long-term safety of elvitegravir are planned and ongoing.

Who should not take elvitegravir?

•  It is not known whether elvitegravir will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
   
•  It is not known whether elvitegravir passes into breast milk and what effect it 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.

Where can I learn more about clinical trials of elvitegravir?

• If you would like to find out if you are eligible for any clinical trials that include elvitegravir, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
   
• Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have “health information specialists” you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

• Ibalizumab is an experimental entry inhibitor being developed by Taimed Biologics. It has not yet been evaluated by the U.S. Food and Drug Administration (FDA) for use by people living with HIV.
   
• Ibalizumab contains genetically engineered antibodies, known as monoclonal antibodies. These antibodies bind to the CD4 receptor on T-cells. Once ibalizumab binds to these receptors, HIV cannot successfully connect with the surface of T-cells, thus preventing the virus from infecting healthy cells.
   
• Ibalizumab will most likely need to be used in combination with other anti-HIV drugs.

What is already known about ibalizumab?

• A dose for ibalizumab has not yet been determined. The drug is administered intravenously, once every two weeks, using a dose that depends on body weight.
   
• Ibalizumab holds promise for HIV-positive patients who no longer respond to other anti-HIV drugs. Because ibalizumab targets HIV differently than most currently available drugs, chances are that most people living with the virus—regardless of which drugs they have tried (and failed) in the past—will likely benefit from using ibalizumab.
   
• It is not known how quickly resistance to ibalizumab develops if resistance does occur.
   
•  Ibalizumab might interact with other medications, including those used to treat HIV. It is important that your personal physician and/or the research nurse or study investigator be aware of all drugs you are taking, including those you buy without a prescription.
   
• A Phase II study of ibalizumab will be enrolling in 2009 and scheduled to complete by 2010.

What about drug interactions?

• No studies have yet reported whether ibalizumab may interact with other drugs. Trials to determine potential drug interactions are planned or ongoing.

What is known about side effects?

• Information regarding the safety and possible side effects of ibalizumab in HIV-positive people has not yet ben reported. Studies to determine the potential side effects of ibalizumab are planned or ongoing.

Who should not take ibalizumab?

•  It is not known whether ibalizumab will harm an unborn baby. It is very important to treat HIV/AIDS during pregnancy to reduce the risk of infecting your baby. Talk to your doctor about your treatment options.
   
•  It is not known whether ibalizumab passes into breast milk and what effect it 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.

Where can I learn more about clinical trials of ibalizumab?

• If you would like to find out if you are eligible for any clinical trials that include ibalizumab, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
   
• Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. They have “health information specialists” you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

What is Selzentry?

• Selzentry is a CCR5-blocking entry inhibitor manufactured by Pfizer. It was approved by the U.S. Food and Drug Administration (FDA) in August 2007. Selzentry is approved for treatment-experienced people who have HIV strains that are resistant to multiple antiretroviral drugs. It is not yet approved for people with drug-sensitive HIV strains, such as those starting antiretroviral therapy for the first time.
   
• In countries other than the U.S., maraviroc will be approved and sold under the brand name Celsentri.
   
• Selzentry binds to a protein on the membrane of CD4 cells (T-cells) called CCR5. Once it does this, HIV cannot successfully attach itself to the surface of CD4 cells, and is thus prevented from infecting healthy cells.
   
• Selzentry must be combined with other HIV drugs.
   

What is already known about Selzentry?

• Selzentry is available in 150 mg and 300 mg tablets and must be taken twice a day. Because of interactions with other medications, including some used to treat HIV, the dose will need to be carefully determined by your healthcare provider. See “What about drug interactions?” below for more information.
   
• Selzentry holds promise for HIV-positive patients who no longer respond to other HIV drugs. Because Selzentry targets HIV differently than most currently available antiretrovirals, chances are that many people living with the virus—regardless of which drugs have failed them in the past—will likely benefit from using Selzentry. Two large clinical trials have determined that Selzentry, when combined with other drugs, is effective for patients whose virus has adapted to other HIV drugs used in the past. However, Selzentry worked best when it was combined with at least two other drugs that the virus was sensitive to (patients who used Selzentry in combination with drugs that their virus was highly resistant to did not experience decreases in their viral load for very long). For this reason, it is best to use drug-resistance testing to determine which drugs your virus is sensitive to; the results will show which antiretrovirals are best to combine with Selzentry.
   
• Selzentry is not yet approved for people with HIV that have no, or limited, resistance to other available antiretroviral drugs. This includes HIV-positive people beginning treatment for the first time. Preliminary data from a study evaluating the drug in patients new to HIV treatment suggest that Selzentry is somewhat inferior to standard-of-care Sustiva (efavirenz). However, moderate CD4 count and side-effect benefits were found to be associated with the drug, compared to Sustiva.
   
• Selzentry will only be effective at reducing viral load in people with HIV that uses the CCR5 receptor. It will not be effective against virus that uses another CD4 cell coreceptor, called CXCR4 (and the drug will have a limited effect against HIV with that uses both receptors). Because CXCR4-”tropic” and “dual-tropic” HIV is more common in people who have been infected with HIV for several years—the people who are most likely going to be using Selzentry—a laboratory test called a tropism assay is necessary before Selzentry can be used, to determine if treatment with the drug will be useful.
   
• Resistance concerns are twofold: 1) mutations in HIV’s gp120 protein can cause resistance to the drug (but not necessarily to other entry inhibitors); and 2) while taking a CCR5 inhibitor, it is possible that CXCR4-tropic virus will emerge and not be affected by the presence of Selzentry or any other CCR5-blocking entry inhibitor. More data from studies of Selzentry are needed to better understand the risk and impact of resistance-causing mutations and the emergence of CXCR4-tropic HIV while on treatment.
   

What about drug interactions?

• Selzentry is broken down (metabolized) by the liver, like many medications used to treat HIV and AIDS. This means that Selzentry can interact with other medications. While it is not expected that the drug will lower or raise the levels of any other medications in the body, studies have shown that other drugs can affect levels of Selzentry in the body.
   
• At the time of Selzentry’s approval in August 2007, there were no known “contraindications,” meaning that there are no known medications that must be avoided while taking Selzentry.
   
• Anticonvulsants, such as Tegretol (carbamazepine), Luminal (phenobarbital), and Dilantin (phenytoin), can decrease the amount of Selzentry in the bloodstream. If these medications are used, the maximum Selzentry dose (two 300 mg twice daily) may be necessary.
   
• Other HIV drugs can interact with Selzentry. Some HIV medications are “CYP3A inhibitors,” meaning that they slow the ability of certain enzymes that are responsible for metabolizing, or breaking down, Selzentry in the body. Some HIV medications are “CYP3A inducers,” meaning that they can speed up the metabolism of Selzentry in the body. Still others do not have a significant effect on CYP3A enzymes. The dose of Selzentry will need to be adjusted, depending on which HIV medications are being used:
   
  • CYP3A inhibitors: If Selzentry is combined with protease inhibitors (with the exception of Aptivus [tipranavir] plus Norvir [ritonavir]) or Rescriptor (delavirdine), the correct dose is one 150 mg tablet twice a day.
  • CYP3A Inducers: If Selzentry is combined with Sustiva and other medications—without CYP3A inhibitors—the correct dose is 600 mg (two 300 mg tablets) twice a day.
  • Other Antiretrovirals: If Selzentry is combined with Aptivus/Norvir, Viramune (nevirapine), Fuzeon (enfuvirtide), or any nucleoside reverse transcriptase inhibitors—without CYP3A inhibitors—the correct dose is one 300 mg tablet twice a day.
     
• Selzentry can interact with some medications used to treat TB, MAC, and other bacterial infections. Rifadin (rifampin) can decrease Selzentry levels, meaning that the Selzentry dose (provided that CYP3A inhibitors are not being used as well) should be 600 mg (two 300 mg tablets) twice a day. Biaxin (clarithromycin) increases Selzentry levels, requiring a Selzentry dose of one 150 mg tablet twice a day.
   
• Selzentry can interact with some medications used to treat thrush (candidiasis) and other fungal infections. Nizoral (ketoconazole) and Sporanox (itraconazole) can increase Selzentry levels in the bloodstream. If these medications are used, the Selzentry dose should be one 150 mg tablet twice a day.
   
• Other medications, including those known to have a strong inhibitory effect on CYP3A enzymes, can interact with Selzentry and may require dosing adjustments. Tell your doctors and pharmacists about all medicines you take. This includes those you buy over-the-counter and herbal or natural remedies. 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.
   

What is known about side effects?

• The most common side effects associated with Selzentry therapy in clinical trials involving treatment-experienced patients were cough, fever, colds, rash, muscle and joint pain, stomach pain, and dizziness.
   
• Although there hasn’t been an overall increase in serious liver problems in patients treated with Selzentry in clinical trials, liver toxicity has been seen in some patients using the drug. Certain allergy-like signs and symptoms—for example, rash, an increase in the number of eosinophils (a type of white blood cell) or elevated IgE antibodies—prior to the development of liver toxicity may occur. If these signs or symptoms occur while taking Selzentry, patients should be evaluated immediately.
   
• In clinical trials, more cardiovascular events, including heart attacks, were seen in patients receiving Selzentry as compared to placebo. In turn, the manufacturer and the FDA are recommending that the drug be used with caution in patients at increased risk for cardiovascular events.
   
• Because Selzentry blocks the CCR5 coreceptor located on some immune system cells, there is a theoretical risk of developing infections and cancers.
   

Can pregnant women take Selzentry?

• Selzentry 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 that there have been no adequate and well-controlled studies in pregnant women. HIV-positive women who become pregnant should discuss the benefits and possible side effects of anti-HIV treatment to help protect their babies from HIV (see our lesson called Family Planning, Pregnancy & HIV).
   
•  It is not known whether Selzentry passes into breast milk and what effect it 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.
   

Where can I learn more about clinical trials of Selzentry? 

• If you would like to find out if you are eligible for any clinical trials that include Selzentry, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.
   
• Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health. NIH has “health information specialists” you can talk to at their toll-free number at 800.HIV.0440 (800.448.0440)