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
Neuropathy is a painful nerve condition that affects about 1 in every 3 HIV+ patients. HIV medications sometimes known as "d-drugs" like ddI (Videx), ddC (Hivid), and d4T (Zerit) can make this condition worse. At this year's conference, several studies were presented that looked at alternative therapies to reduce the pain associated with neuropathy. Capsaicin (pronounced "cap-say-sen") is the substance in chili peppers that makes them spicy and was one such therapy studied (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 490). In this small study, 12 patients were first treated with a topical (on the skin) anesthetic for 1 hour followed by a 1-hour application of a capsaicin skin patch to the painful area. Patients were only treated one time and then studied for 12 weeks. Over half of the patients felt less pain at that site during the 12-week study period. Patients did experience mild discomfort during and shortly after treatment, but generally tolerated the patch well. In another small study, marijuana was also shown to lessen the pain associated with this condition (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 496 ). Ten out of 16 patients had a significant reduction in pain after smoking cigarettes containing THC (the active ingredient in marijuana) 3 times a day for 7 days.
Another study looked at the effect of a specially formulated multivitamin supplement (consisting of several pills) on reducing neuropathy pain (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 494). This study was a "double-blind" study, meaning that both patients and healthcare workers did not know which treatment each patient was receiving. Forty patients with neuropathy who were taking Zerit or Videx were randomly assigned (by chance, like flipping a coin) to receive the specially formulated multivitamin supplement or a placebo twice daily for 12 weeks. Though patients taking the multivitamin experienced some pain relief, the effect was small. However, the researchers discovered that the multivitamin did increase T cell counts, suggesting this type of supplement may benefit people with HIV.
There is a perception that HIV+ patients will have more complications after surgery because of a suppressed immune system. However, a study presented at the conference may put these fears to rest (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 82). To see if HIV+ patients actually had more surgical complications than the general population, researchers compared HIV+ patients to HIV-negative patients who had the same type of surgery in the same year and who were the same age and sex. In all, 295 pairs of patients were examined (a pair was made up of an HIV+ patient and an HIV-negative patient), including HIV+ patients who had an AIDS diagnosis or a history of an opportunistic infection. The researchers discovered that the number of surgical complications and deaths was similar for HIV+ and HIV-negative patients. However, those patients with viral loads greater than 10,000 were more at risk for complications. The researchers caution that many high-risk HIV+ patients may not have had surgery, and therefore this study may not tell the complete story.
A previous study showed that 4 mg a day Serostim (human growth hormone) given for 12 weeks decreased the amount of fat in the abdominal area (a condition associated with lipodystrophy). Serostim also reduced cholesterol levels. Unfortunately, some patients had side effects at that dose and any positive changes reversed once patients stopped taking Serostim. A follow-up study presented at the conference showed that in patients previously treated with the higher dose of Serostim, a smaller dose (1 or 2 mg per day) could maintain these positive changes with fewer side effects (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 80).
Lipoatrophy is the loss of fat in the face, arms, or legs and is a side effect of HIV treatment. Injections of polylactic acid (also known as NewFill and to be sold upon US approval as Sculptra) have been used for the treatment of facial lipoatrophy for several years, but the long-term effects are not known. A study presented at the conference (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 726) described 94 patients who received at least 1 injection of polylactic acid (mixed with an anesthetic). Patients received an average of 5 injections of polylactic acid in both cheeks every 15 days. At the end of treatment, 87% of patients reported that they were more satisfied with their face in terms of the lipoatrophy. However, statistical tests showed that almost half of the patients would require additional injections within 15 months. The most common side effects of this treatment included mild to moderate pain and swelling at the injection site.
As more patients are taking combination antiretroviral therapy (known as HAART), the types and frequency of cancers affecting HIV+ patients are changing dramatically. Prior to the introduction of HAART in 1996, 3 types of cancer were common in HIV+ individuals: Kaposi's sarcoma (KS), cervical cancer, and non-Hodgkin's lymphoma (NHL). With the help of a large collection of patient records, one study showed that the rates of KS and cervical cancer have decreased (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 81). However, rates of other types of cancer have increased, including Hodgkin's disease, melanoma, and cancers of the lung, anus and rectum, and head and neck. While this particular analysis showed that incidence of NHL has not changed much, another study reported that the number of cases of NHL in patients with AIDS has dropped significantly (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 786), demonstrating the complexity of this issue. Other studies presented also found that cancer of the anus and rectum is more common in HIV+ people compared to the general population (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 777) and that these rates have increased since the introduction of HAART (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 778). Some possible explanations are that people with HIV are living long enough to get such diseases, which may occur because of immune problems not fixed by HIV medications. In addition, another research group reported that cancer was responsible for over a quarter of AIDS deaths when they studied a group of 964 HIV+ people (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 875).
Chronic weight loss and wasting are well-known features of AIDS. However, in the current era of HIV treatment, obesity is affecting HIV+ people almost as much as it is affecting the general population. A study presented at the conference examined 1654 HIV+ individuals and found that obesity was 5 times more common than wasting (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 879). Women, African-Americans, and those with T cell counts over 200 were more likely to be obese. As treatment options for HIV improve and patients continue to live longer, obesity may lead to problems that also affect lifespan, such as heart disease and stroke.
Several studies looked at bone mineral density, which is a measurement of bone strength, in HIV+ people. One study examined 272 women (both HIV+ and HIV-negative) and found that HIV+ women were 3 times more likely to have decreased bone strength (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 744). This loss in bone strength can lead to serious bone fractures, such as hip fractures, that can result in an extended hospital stay and the need for physical therapy. In addition, this condition may even lead to fragility fractures. These types of fractures can occur with little or no trauma. According to another study presented at the conference, patients who have fragility fractures commonly have more serious bone fractures later (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 743). The effects of Fosamax (alendronate) in treating this loss of bone strength was tested in an "open-label" study, meaning that patients knew which treatment they were receiving (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 742). Forty-one HIV+ men and women were randomly assigned (by chance, like flipping a coin) to receive Fosamax combined with calcium and vitamin D supplements or just calcium and vitamin D supplements. Fosamax had no effect on increasing bone mineral density, but had other beneficial effects.
Rosiglitazone (brand name: Avandia) is a drug used to treat diabetes. This drug is being tested for the treatment of fat wasting (lipoatrophy) and related problems in body metabolism, such as with fats and sugars, found in people with HIV. Unfortunately, the most recent results of rosiglitazone's effect on lipoatrophy are disappointing. In a "double-blind" study, meaning that both patients and healthcare workers did not know which treatment each patient was receiving, HIV+ patients with lipoatrophy were randomly assigned (by chance, like flipping a coin) to receive a placebo (55 patients) or 4 mg of rosiglitazone twice a day (53 patients) for 48 weeks (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 79). Rosiglitazone had no beneficial effect on body changes associated with lipoatrophy. However, patients taking this drug did experience increased levels of adiponectin (a hormone secreted by fat cells that affects the body's response to insulin and may have other important effects) and improved insulin sensitivity (allowing better control of blood sugars), both of which are beneficial. These findings were recently published in Lancet. 2004 Feb 7;363(9407):429-38.
Several studies presented at the conference looked at cognitive function (the ability to think and understand information) in patients with HIV or AIDS. Most of these studies used a group of mental tests to determine how well patients processed and understood information. In one study of 240 patients, this type of testing showed that about 40% of patients with advanced AIDS had difficulty with these tests (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 498). This study also showed that patients with an undetectable viral load (less than 500) did better on these tests compared to patients with detectable viral load. Another study showed that being co-infected with hepatitis C (HCV) also appears to have a negative effect on cognitive function. Researchers tested 235 HIV+ patients (25 of these patients were co-infected with HIV and HCV) and found that co-infected patients were more likely to show symptoms of cognitive difficulties (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 26). In addition, co-infected patients tended to be more depressed. In a separate study, HIV+ patients who had impaired cognitive function were more likely to die during the 7-year study period, compared to patients without these symptoms (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 507). This study also reported that higher viral loads and co-infection with HCV were linked to difficulties in understanding and processing information. Actual damage to the brain caused by HIV could be responsible for these problems. One study reported that minor brain damage, specifically loss of nerve insulation, occurs in some HIV+ patients despite being on HIV medications (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 33LB). This damage was more apparent in those patients with detectable viral loads. A common theme in these studies is the importance of suppressing HIV and avoiding HCV infection, which can make health issues worse.
High levels of triglycerides (a type of fat that travels in the blood) and cholesterol can be common in HIV+ patients and are risk factors for heart disease. This condition can be made worse by certain HIV medications. One small study looked at the effect of Pravachol (pravastatin), a drug used to lower cholesterol (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 77). In this "double-blind" study, meaning that patients and healthcare workers did not know which treatment each patient was receiving, patients were randomly chosen (by chance, like flipping a coin) to receive Pravachol or a placebo. Pravachol significantly reduced cholesterol levels and had other beneficial effects. The combination of Pravachol and Tricor (fenofibrate), a drug used to treat high triglyceride levels, was also investigated in another study (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 723). Here, patients initially took Pravachol (86 patients) or Tricor (88 patients), but later received both drugs if their cholesterol and triglyceride levels had not dropped after 12 weeks. The combination of these 2 drugs appeared safe, but few patients had significant decreases in triglycerides or cholesterol. In a separate study (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 724), patients were randomly assigned to take fish oil (about 3 grams a day) combined with diet and exercise counseling (25 patients) or to just receive diet and exercise counseling alone (19 patients). In general, fish oil reduces the risk of heart disease. While triglyceride levels dropped in patients who received fish oil, the drop was not dramatic. However, these results are encouraging since patients tolerated the fish oil and reported few side effects. The studies are difficult to compare directly because their definitions of success are different. One study (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 723) wanted to see if patients could achieve cholesterol and triglyceride levels cited by the National Cholesterol Education Program, while another study (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 77) just looked at whether these levels had decreased significantly.
HIV can cause damage to the brain, including problems in thinking and understanding information. This damage is thought to occur because certain HIV drugs cannot get into the brain to suppress the HIV infection. The blood-brain barrier (BBB) is a tightly connected network of cells that surrounds the brain and protects it from outside substances. However, the BBB also prevents many beneficial drugs from entering the brain. At the conference, 2 studies questioned whether using HIV medications that are able to get through the BBB actually protect against damage caused by HIV. In the first study (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 501), the cognitive ability of 32 HIV+ patients taking one of the medications believed to penetrate the BBB was compared to that of 14 HIV+ patients not taking one of these drugs. A second study (Conf Retroviruses Opportunistic Infect. 2004 Feb 8-11;11th: Abstract No. 508) examined 165 HIV+ patients and also compared cognitive ability in those patients taking an HIV medication thought to penetrate the BBB to those patients who were not. Both studies found that a higher viral load was associated with cognitive problems, rather than the specific HIV medications. In the second study, higher levels of education were shown to protect patients against these types of problems. In terms of protecting the brain and the body from HIV, the most important factor is keeping viral load low. Patients should be sure to have their viral load measured every 3 to 4 months and take HIV medications regularly and on-time.
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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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