Important note: Information in this article was accurate in June 2004. The state of the art may have changed since the publication date.
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HIV Treatment Alerts - June 2004
A report in the journal Biol Psychiatry. 2003 Dec 15;54(12):1444-56 describes how researchers assessed 54 homosexual HIV+ men to study the connection between shyness (feeling inhibited in social situations) and physical health. Men who were shy had a significantly higher viral load set-point (a starting point for viral load after early or "acute" HIV infection) and had a poor response to HIV drugs compared to the HIV+ men who were not shy. In a related study published in the BMJ. 2004 Jan 3;328(7430):15, researchers followed over 3700 HIV+ patients and found that people who were in a stable relationship did not progress to AIDS or die as quickly as those who were not in a stable relationship. The reasons for these benefits are not known, but the researchers believe that being part of a stable relationship may prevent depression and improve drug adherence, therefore improving the health of these patients.
The risk of contracting HIV infection through sex is dramatically increased in those who use methamphetamine (meth or crystal meth). Individually, both meth and HIV cause damage to the brain and brain cells. A study published in the J Acquir Immune Defic Syndr. 2003 Dec 15;34(5):467-74 examined brains (during an autopsy) from 34 HIV+ men who used meth regularly and 43 HIV+ men who did not use meth. While brain damage and cell death were apparent in all patients regardless of whether they used meth, different types of damage were detected in the brains of meth users. The researchers believe that HIV and meth work together to cause this damage. It is important that research continues in this area to find ways to protect the brain from HIV.
Can HIV medications protect the brain from damage caused by HIV infection? In a study published in the journal Neuroreport. 2003 Nov 14;14(16):2111-5, researchers measured electrical activity in the brain and performed MRI scans to look at brain function and structure in 39 HIV+ people. Patients were also tested with various mental exercises to see how well they processed and understood information and to test their reaction time. Compared to the control group (39 HIV-negative people), brain structure and electrical activity in HIV+ people were affected by HIV infection. In addition, tests showed that HIV+ patients had more difficulty processing and understanding information. Patients with detectable viral loads (over 50 copies) tended to perform worse on these tests compared to HIV+ patients with an undetectable viral load. The findings show that while HIV medications are beneficial, they do not completely protect the brain against HIV.
Though HIV medications have dramatically improved the lives of persons with HIV, their side effects can be serious. According to a study in the J Acquir Immune Defic Syndr. 2003 Dec 1;34(4):379-86, an HIV+ person is more likely to have a serious or life-threatening side effect than an AIDS-related event. In this study, the number of serious or life-threatening side effects, AIDS-related events, and deaths were recorded for 2947 HIV+ patients taking HIV medications. The researchers found that these types of side effects occurred about twice as often as AIDS-related events. Common issues included liver problems, decreases in white blood cells, anemia, and heart problems, and these were sometimes life-threatening. The researchers suggest that tailoring a drug regimen according to each patient's risk factors may reduce these kinds of side effects.
First-line HIV treatment, that is, the first treatment you are prescribed after being diagnosed with HIV, is very important because it has the best chance of suppressing HIV. A study published in the J Acquir Immune Defic Syndr. 2003 Dec 1;34(4):407-14 looked at medical records from 345 HIV+ patients who had recently started taking HIV medications and found that 61% of the patients stopped or changed their drugs after about 8 months. Side effects such as nausea, vomiting, and diarrhea were frequently responsible. These findings stress the importance of understanding why patients sometimes stop taking their medications. Good communication between the healthcare provider and patient is very important because healthcare providers can counsel patients on what to expect and perhaps provide medications to treat or to prevent these side effects.
According to a study published in the journal Stroke. 2004 Jan;35(1):51-6, young adults (aged 15 to 44 years) with AIDS are 10 times more likely to have a stroke or intracerebral hemorrhage (bleeding inside the brain caused by a ruptured blood vessel) than people in the same age group without AIDS. When researchers examined hospital charts from 556 patients who had a stroke or intracerebral hemorrhage, the risk of these conditions was much higher in patients with AIDS compared to patients without AIDS. While the incidence of stroke was higher in patients with AIDS, risk factors associated with stroke (for example, high blood pressure, elevated cholesterol levels, or smoking) were similar in both groups. These findings suggest that damage to the brain caused by HIV may be responsible for this increased risk. However, a few things should be pointed out about this study. First, patients who were HIV+ but who had not progressed to AIDS were grouped in the "no AIDS" category. In addition, the researchers studied medical records from patients in 1988 and in 1991, before combination HIV therapy was available. It will be important to see how the widespread use of combination therapy affects this risk.
Can a healthy diet prevent lipodystrophy in HIV+ patients? A study published in the Am J Clin Nutr. 2003 Oct;78(4):790-5 followed HIV+ men who had no signs of lipodystrophy at the beginning of the study. The researchers met with patients every 6 months to discuss their food habits and to see if signs of lipodystrophy were apparent. The food habits of the 47 patients who eventually showed signs of lipodystrophy were compared with 47 patients in the control group who did not have lipodystrophy. HIV+ men without lipodystrophy tended to consume more dietary fiber, pectin (a nutrient found in fruits), and protein. These men were also more likely to include resistance training (weight lifting) in their exercise routine and to not smoke cigarettes.
In another study, published in the journal Antivir Ther. 2003 Oct;8(5):403-10, researchers studied the effect of various medications on treating lipodystrophy. Patients were randomly assigned (by chance, like flipping a coin) to receive gemfibrozil (Lopid), a drug used to treat dyslipidemia (37 patients); metformin (Glucophage), a drug used to treat insulin resistance (35 patients); or a placebo (36 patients). This was a "double-blind" study, meaning that both patients and healthcare workers did not know which treatment each patient was receiving. During the 1-year study period, all patients experienced a total loss of fat, regardless of which treatment they received (including the placebo). However, none of these medications had a major effect on abdominal obesity, a common problem in patients with lipodystrophy.
Though the jury is still out on whether certain drugs can actually treat lipodystrophy, a preventative approach is important, and good nutrition and a healthy lifestyle should never be overlooked.
Understanding the risk factors for lipodystrophy may allow researchers to find successful treatments. According to a study in the journal Clin Exp Immunol. 2004 Feb;135(2):273-9, there may be a link among blood levels of adiponectin (a hormone secreted by fat cells that affects the body's response to insulin and may have other important effects); previous or current treatment with the HIV drug, Zerit; and the development of lipodystrophy. Researchers studied 42 HIV+ men, 27 of whom had lipodystrophy. Healthy HIV-negative men were also included as a control group. HIV+ patients with lipodystrophy had lower blood levels of adiponectin, especially those patients who had used Zerit, compared to HIV+ patients without lipodystrophy. In fact, all HIV+ patients who had taken Zerit (regardless of whether they had lipodystrophy), had lower levels of adiponectin.
The issue of whether combination HIV therapy (HAART) leads to an increased risk of having a heart attack is controversial. However, a recent study published in N Engl J Med. 2003 Nov 20;349(21):1993-2003 may provide some answers. This large study looked at over 23,000 HIV+ patients from 21 different countries including the US, Australia, and countries in Europe to determine the number of heart attacks in this population. During the study period, 126 patients had a heart attack. The number of heart attacks increased as exposure to HAART increased, showing a possible connection between heart attack risk and the use of HAART. Patients who had never taken HIV medications had the lowest incidence of heart attacks. Other risk factors included those that also affect the general population, such as older age, cigarette smoking, history of heart disease, diabetes, being male, and having high levels of triglycerides (a type of fat that travels in the blood) and cholesterol. The researchers point out that the risk of a heart attack was still relatively rare in HIV+ patients taking HAART and that the obvious benefits of HAART still outweigh the risks.
According to 2 studies done by the same research group (the AIDS Clinical Trials Group 384 Team), the combination of Retrovir, Epivir, and Sustiva is the best initial treatment for HIV infection. Initial (also known as "first-line") treatment is very important because it has the best chance of suppressing HIV. The first study, published in N Engl J Med. 2003 Dec 11;349(24):2293-303, looked at 620 HIV+ patients, the vast majority of whom had never taken HIV medications before. Researchers tested the effect of various HIV medications when taken in different combinations, including Videx, Zerit, Retrovir, Epivir, Viracept, and Sustiva. Patients were randomly chosen (by chance, like flipping a coin) to receive 3 of these drugs (2 nukes and either Viracept or Sustiva). If patients had serious side effects or if their treatment stopped working, patients were switched to another 3-drug combination. Patients taking the combination of Retrovir, Epivir, and Sustiva had fewer side effects and this combination suppressed HIV the fastest and longest after starting treatment. In fact, patients who initially took this combination also responded better to the second drug combination. Note: Retrovir and Epivir are available in one pill called "Combivir."
The second study, also published in N Engl J Med. 2003 Dec 11;349(24):2304-15, investigated whether 4 HIV medications were better than 3 for controlling HIV infection (currently, most HIV+ patients take 3 medications). This study examined the same medications as the above study and used various combinations of 3 or 4 medications. A total of 980 HIV+ patients who had never taken HIV drugs before were randomly chosen to receive one of these combinations. Researchers found that there was no significant benefit when patients took the 4-drug combination. In agreement with the above study, this study also showed that the combination of Retrovir, Epivir, and Sustiva suppressed HIV the best. The researchers caution that the combination of Zerit and Videx should not be used for initial therapy because it can cause serious side effects.
Viramune warning. New precautions have been added to the labeling for Viramune, a non-nucleoside reverse transcriptase inhibitor (NNRTI or "non-nuke"). Women with T cell counts greater than 250, including pregnant women, who are treated with Viramune are at a greater risk for developing liver damage. Viramune should not be used in women with T cell counts greater than 250 because this type of liver damage can be life-threatening. Anyone (both men and women) taking Viramune should be carefully monitored by a healthcare provider because serious liver damage can occur in anyone. Patients developing a skin rash should tell their healthcare provider immediately as this may be a sign that the medication is causing problems.
FDA approves HIV drug. Last fall, the Food and Drug Administration (FDA) approved the protease inhibitor, Lexiva, to help treat HIV. Lexiva is a new version of the drug Agenerase and is taken in combination with other HIV drugs. For patients who have never taken protease inhibitors, Lexiva can be taken once or twice a day, depending on the Lexiva dose and whether Norvir (another protease inhibitor) is taken to boost Lexiva. For patients who have previously taken many protease inhibitors, Lexiva should only be taken twice a day with Norvir. For more information, such as important drug interactions and possible side effects, see The CFA's fact sheet on Lexiva at www.centerforaids.org/rita/facts/lexiva.pdf.
New dosing for Invirase and Fortovase. In December, the FDA approved new dosing guidelines for Invirase and Fortovase, 2 brand-name versions of the HIV medication, saquinavir. The new dose for both Invirase and Fortovase is 1000 mg two times a day when taken with Norvir (another protease inhibitor used to boost levels of other medications). Invirase should always be used with Norvir. Fortovase can be taken with or without Norvir, though patients may need to take Fortovase more frequently if Norvir is not taken.
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Copyright © 2004 - Research Initiative Treatment Action (RITA!). Reproduced with permission. RITA! is published by The Center for AIDS. Contact Thomas Gegeny, MS, ELS, Editor, RITA! for permission to reproduce RITA!. tom@centerforaids.org. http://www.centerforaids.org
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