• Statins to Treat HIV?
• Grapefruit Juice Warnings Continue
• New Treatments for Pain
• Breast Enlargement in Men
• Treatment for Diarrhea
• Giving Kids a Fighting Chance
• High Risk of Anal Cancer
• Niacin for Dyslipidemia
• CMV: A Marker of Disease Progression?
• Co-Infection Complications
• Get Vaccinated!
• Triple PI Therapy for Salvage
• Effects of Smoking on Cervical Cancer Risk
• Pneumococcal Disease: Is it Still a Threat?
• Breathing Problems
• Fuzeon Recommendations
• Videx + Viread Interactions
• FDA Bits

Statins to Treat HIV?

Statins are a widely prescribed group of drugs used to treat high cholesterol. Sometimes, statins are also given to HIV-positive individuals to treat lipodystrophy. A recent report in the Journal of Experimental Medicine (200, p. 541, 2004) describes how statins may actually fight HIV. Researchers initially did several studies in test tubes and mice showing that statins inhibited HIV infection. The researchers then examined the effect of one statin, Mevacor, in 6 patients with chronic and stable HIV infection who were not taking HIV medications. After taking Mevacor once a day for 1 month, all of the patients experienced a decrease in HIV viral load and an increase in T cells. These positive effects reversed once patients stopped taking Mevacor. The results suggest that different types of drugs, perhaps with fewer side effects than HIV medications, may be useful in the fight against HIV. However, this was a very small study and larger studies must be done to look at the effects of combining statins and HIV medications.

Grapefruit Juice Warnings Continue

Many HIV-positive individuals take statins to treat high cholesterol. This group of many refrigerators may interact with these drugs and could be dangerous. A report in the journal Neurology (62, p. 670, 2004) describes a 40-year-old HIV-negative woman who had been taking Zocor for high cholesterol for more than 2 years. After experiencing muscle weakness and pain for 10 days, she was diagnosed with a degeneration of skeletal muscle tissue called "rhabdomyolysis" (pronounced rab-doe-my-OL-i-sis). Evidently, the woman had eaten a grapefruit every morning for the last 14 days. Grapefruits and grapefruit juice contain a substance that increases the blood levels of some statins. In addition, this fruit can also interact with certain HIV medications. If you are taking a statin, check with your healthcare provider to find out more about potential drug interactions. Keep in mind that grapefruits and grapefruit juice could make any drug interactions between HIV medications and statins even worse.

New Treatments for Pain

Neuropathy is a condition where people experience nerve damage, muscle weakness, pain and numbness. Typically peripheral nerves, such as those in the arms and legs, are affected. Some types of HIV medications, particularly the nucleoside reverse transcriptase inhibitors (NRTIs or "nukes") can make this condition worse. In HIV-positive patients with this condition, blood levels of a natural substance called acetyl-L-carnitine (ALCAR) tend to be lower. In a study published in the journal AIDS (18, p. 1549, 2004), 21 HIV-positive patients with HIV-related neuropathy took ALCAR by mouth twice a day for up to 33 months. Skin biopsies from the leg were taken every 6 to 12 months to assess nerve damage. For most of the patients, ALCOR lessened neuropathy pain and caused regrowth of nerves.

Acupuncture could be another potential treatment for neuropathy. This traditional Chinese therapy involves putting very thin needles into the skin at certain points on the body to produce energy flow. Though is it frequently used to treat chronic pain, its effect on HIV-related problems is unknown. In a study described in The Journal of Alternative and Complementary Medicine (10:3, p. 449, 2004), 21 patients with HIV-related neuropathy underwent 10 acupuncture sessions over a 5-week period. Patients reported a dramatic decrease in pain, aching, burning, tingling and numbness.

In Houston, the American College of Acupuncture & Oriental Medicine (ACAOM) has partnered with Montrose Clinic to offer acupuncture to the clinic patients. ACAOM faculty members have begun treating patients with HIV/AIDS-related symptoms including neuropathy, depression and other related disorders. Initial treatments have been very encouraging, with many experiencing relief of symptoms. For more information regarding ACAOM, visit www.acaom.edu. For more information about the Montrose Clinic, visit www.montroseclinic.org or call 713-830-3000.

Breast Enlargement in Men

About 2% to 3% of HIV-positive men have a condition called gynecomastia (pronounced guy-ni-ko-MAS-tee-uh), which means abnormal breast enlargement. This condition can also occur in HIV-negative men during puberty or when men are elderly or overweight. In addition, certain medications, including street drugs, can cause this condition. A study published in the journal AIDS (18:9, p. 1347, 2004) shows that the HIV medications Zerit and Videx may cause gynecomastia. When 47 HIV-positive men with gynecomastia were examined, researchers found that a large percentage of these men were taking one of these drugs. However, another report published in The Breast Journal (10:3, p. 244, 2004) suggests a link between gynecomastia and the HIV medication Sustiva. The report describes 5 men with gynecomastia who were all taking Sustiva. Plus, the gynecomastia improved after the patients stopped taking Sustiva. While these 2 studies suggest that certain HIV medications could be responsible for gynecomastia, both studies were very small. HIV-positive people who experience this type of side effect should discuss concerns with their healthcare providers.

Treatment for Diarrhea

Excessive diarrhea and wasting are not that common in the US, but are major problems in developing countries. These problems can also cause decreased absorption of HIV medications into the body, resulting in virus that can become resistant to those HIV medications. A study conducted in Brazil and published in the journal Clinical Infectious Diseases (38, p. 1764, 2004) looked at 41 patients with AIDS who had diarrhea and/or wasting. Patients were randomly assigned (by chance, like flipping a coin) to receive a nutritional supplement or a placebo by mouth for 7 days. The supplement given was either glutamine or alanyl-glutamine, which is a more stable form of glutamine. This was a "double-blind" study, meaning that both patients and healthcare workers did not know which treatment each patient was receiving. Patients taking glutamine or alanyl-glutamine experienced less diarrhea and had higher blood levels of HIV medications compared with patients taking a placebo. These results show that taking glutamine (or alanyl-glutamine) in combination with HIV medications may help people with HIV/AIDS, especially in developing countries.

Giving Kids a Fighting Chance

When to treat HIV-positive infants and young children and how aggressively to do so are still unanswered questions. A recent study published in The New England Journal of Medicine (350:24, p. 2471, 2004) examined 3 different HIV regimens in 52 children. Children were grouped according to their age at the beginning of the study: 3 months or younger (considered "early therapy") or older than 3 months (considered "delayed therapy"). While no serious side effects were seen with any of the combinations, the combination of Zerit, Epivir, Viramune and Viracept suppressed HIV the best after 1 year and after almost 4 years of treatment. Researchers also found that treating children within 3 months of birth was better for suppressing HIV.

High Risk of Anal Cancer

Anal cancer is a very real risk for HIV-positive people, especially for men who have sex with men. In addition to HIV, human papillomavirus (HPV), a common sexually transmitted disease, also increases this risk. However, a recent study published in the journal AIDS (18, p. 1561, 2004) explains how other types of infections in the anus can also increase the risk of anal cancer. When researchers examined 199 men and women, both HIV-positive and HIV-negative, they found that in addition to HIV and HPV, infections like herpes simplex virus, cytomegalovirus (CMV), Epstein-Barr virus, or gonorrhea increased this risk.

Typically, the "Pap" smear is used to identify abnormal cells that may indicate the development of certain types of cancer, including cervical and anal cancer. The cells are examined for abnormal changes referred to as "precancerous lesions," meaning that if they are not treated, these early lesions could develop into cancer. Another way to screen for anal cancer is to perform an anoscopy. This type of exam involves using a short lighted scope to look into the anal canal. A biopsy, or tissue sample, can then be removed and examined for abnormal changes. A study in the journal Clinical Infectious Diseases (38, p. 1490, 2004) examined 153 HIV-positive and HIV-negative men who have sex with men and compared ways to detect these precancerous lesions. Researchers found that Pap smears, while cheaper to perform, were less accurate when compared with results from the biopsy. Any HIV-positive person with an abnormal Pap smear should discuss having an anoscopy and tissue biopsy performed to rule out anal cancer or precancerous lesions.

Niacin for Dyslipidemia

Dyslipidemia (abnormal levels of fats in the blood) occurs in many HIV-positive people and may be a side effect of HIV medications. The vitamin supplement niacin has been studied as a treatment for dyslipidemia, but it can cause side effects such as skin flushing and early signs of diabetes. However, a study published in the journal Clinical Infectious Diseases (39, p. 419, 2004) examined the effect of an extended-release form of niacin. This version of niacin may have fewer side effects because it is released into the body at a slower and more even rate. In this study, 14 HIV-positive patients with dyslipidemia who were taking HIV medications took the extended-release niacin for 14 weeks. Patients also received nutritional counseling. Blood levels of cholesterol and triglycerides (a type of fat that travels in the blood) were dramatically lowered following the niacin treatment. In general, the extended-release version was safe and well tolerated. Some patients experienced skin flushing, but aspirin alleviated the flushing and symptoms typically stopped after 10 weeks of niacin treatment. However, some patients did have early signs of diabetes. The extended-release niacin may be option for HIV-positive patients with dyslipidemia, but it may not be safe in patients with diabetes or early signs of diabetes.

CMV: A Marker of Disease Progression?

Cytomegalovirus (or CMV, an opportunistic infection) is still a very real threat to HIV-positive individuals, according to a study published in The Lancet (363, p. 2116, 2004). In this study, 374 HIV-positive patients whose T-cell count was less than 100 had their blood tested for CMV every 3 months. In fact, the researchers found that CMV in the blood was linked to a worsening of HIV disease or death, even in patients taking potent combination HIV therapy (also called HAART). CMV levels may predict whether HIV disease is getting worse and may be useful to identify patients at risk for disease progression. CMV is a fairly common type of herpes virus that usually only causes problem when the immune system is weak.

Co-Infection Complications

Usual treatment for chronic hepatitis C is 6 months to 1 year of pegylated (longer-lasting) or standard interferon combined with ribavirin. Relapse (return) of hepatitis C virus (HCV) occurs in about 15% to 20% of patients who are HCV-positive but HIV-negative. For patients co-infected with both HIV and HCV, the rate of relapse is unknown. In a study published in the journal AIDS Research and Human Retroviruses (20:4, p. 351, 2004), 58 co-infected patients who began the study with undetectable levels of HCV (after successful treatment) were followed to see if and when they relapsed. Within 6 months, 33% of the co-infected patients had relapsed, a number dramatically higher than for those patients who had just HCV. Because of these findings, the authors recommend that future studies examine treating co-infected patients for a longer period of time as a way to lessen the risk of relapse.

Recently, the New York-based HIV advocacy organization, Treatment Action Group, released a report titled, "Hepatitis C Virus (HCV) and HIV/HCV Coinfection: A Critical Review of Research and Treatment." This report reviews the epidemiology, transmission, diagnosis and treatment guidelines for patients with hepatitis C and for patients co-infected with HIV and HCV. In addition, HCV drug development is also discussed. This report is available online at www.aidsinfonyc.org/tag/coinf/hcv2004.

Get Vaccinated!

A study in the Journal of Acquired Immune Deficiency Syndromes (36, p. 869, 2004) reports the high rate of hepatitis B virus (HBV) in the HIV-positive community in the US. When researchers examined blood samples from 240 HIV-positive patients, they found that 65% of these patients had evidence of past or current HBV infection. In addition, 16% of the patients had evidence of "occult" HBV infection. This form of HBV is almost considered hidden because the infection is not detected with the standard tests and requires specific DNA tests to detect it. Occult HBV infection can cause serious liver damage. Importantly, many people with occult infection may not know they are infected and may spread the infection to others. These findings stress the importance of getting vaccinated for hepatitis A and B. (There is no vaccine for hepatitis C). Vaccinations for both hepatitis A and B are available and recommended for people who are at high risk (men who have sex with men, injection drug users and heterosexuals with a recent history of a sexually transmitted disease or multiple sexual partners). In addition, vaccination for hepatitis A is recommended for international travelers and persons with liver disease, including hepatitis C infection. However, according to a study in the journal Clinical Infectious Diseases (38, p. 1478, 2004) that examined the medical charts for 1071 HIV-positive patients, only a third or fewer people received vaccinations for hepatitis A or B and even fewer received the necessary number of vaccine doses. People at risk for getting these infections should discuss getting vaccinated with their healthcare providers.

Triple PI Therapy for Salvage

Researchers report in the Journal of Acquired Immune Deficiency Syndromes (36, p. 921, 2004) that an HIV treatment consisting of 3 protease inhibitors (PIs) may help salvage patients. These patients require new types of treatments because they have taken many HIV medications in the past and their HIV has developed resistance to these drugs. After 24 weeks, the combination of Invirase, Agenerase and Norvir plus nucleoside reverse transcriptase inhibitors (NRTIs or "nukes") decreased viral load and increased T-cell count. Diarrhea was a common side effect but was controlled with medications. Unfortunately, adherence was a major problem with this combination because patients had to take 13 pills twice a day, not including the nukes. In fact, 4 out of the 11 patients in this study dropped out because of poor adherence. However, with a new version of Invirase being developed and the recent re-creation of Agenerase as Lexiva, the pill burden may be significantly decreased, making this treatment combination easier to take in the future.

Effects of Smoking on Cervical Cancer Risk

Smoking is known to be unhealthy, but a recent study shows that it may also increase a woman's risk of developing cervical cancer, especially if she is HIV positive. This study, published in The Journal of Infectious Diseases (189, p. 1821, 2004), examined 1797 HIV-positive women and 496 HIV-negative women for human papillomavirus (HPV), a common sexually transmitted disease that increases the risk of developing cervical cancer. Previous studies have reported that HIV-positive women have HPV more frequently than HIV-negative women, but the current study showed that smoking also increases the chances of having HPV. As a result, the risk of HPV and cervical cancer is very high in HIV-positive women who smoke. Other studies have shown that smoking has a negative effect on the immune system, and this study provides more evidence to support that.

The good news is that potent combination HIV therapy (HAART) is linked to regression, or improvement, of precancerous lesions in the cervix. HIV-positive women are at a greater risk for developing these lesions and, if not treated, these lesions can develop into cervical cancer. A study published in the Journal of the National Cancer Institute (96:14, p. 1070, 2004) compared rates of cervical lesion regression before and after HAART became available several years ago. The researchers found that the chances of regression improved after HAART became available. In addition, higher T-cell counts (probably as a result of HIV treatment) were linked to regression. However, the rate of improvement was still lower in HIV-positive women compared with HIV-negative women. HIV-positive women, even those taking HAART, should have regular gynecologic exams.

Pneumococcal Disease: Is it Still a Threat?

A study published in the journal Clinical Infectious Diseases (38, p. 1632, 2004) reported that even with the availability of potent combination HIV therapy (HAART), HIV-positive individuals are still at risk for pneumococcal (pronounced new-moe-KAW-kul) disease. In fact, when researchers examined medical records from people treated at their hospital for pneumococcal disease between 1996 and 2002, they found that HIV-positive people were 60 times more likely to get this potentially life-threatening disease compared with the general population. However, only one-third of the patients were being treated with HAART and most had a detectable viral load.

Getting vaccinated against pneumococcal disease is recommended for all young children and HIV-positive individuals. However, some vaccines don't work in HIV-positive people because of a suppressed immune system. A study published in the Annals of Allergy, Asthma and Immunology (92, p. 558, 2004) examined 41 HIV-positive children (taking HAART) and 95 HIV-negative children, all of whom received the pneumococcal vaccine. The HIV-positive children did respond to the vaccine, as shown by increased levels of specific antibodies. The vaccine worked the best in HIV-positive children with lower viral loads and higher T-cell counts.

Breathing Problems

Pulmonary arterial hypertension (PAH) is a health condition where there is high blood pressure in the pulmonary artery, a major blood vessel in the lungs. Though somewhat rare, PAH affects HIV-positive individuals more frequently than the general population and can be life-threatening. Symptoms of PAH includes shortness of breath (especially during exercise), chest pain and fainting episodes. The exact cause of PAH is unknown, but it can sometimes be inherited from a family member. In addition, certain medications, particularly diet pills such as Fen-Phen (a combination of fenfluramine and phentermine that was taken off the market several years ago) may cause this condition. To make matters worse, treating PAH in HIV-positive people is more complicated because many of the PAH medications interact with HIV medications. A drug called epoprostenol, combined with potent combination HIV therapy, may improve survival in those patients with PAH. HIV-positive people who experience any of these symptoms should immediately contact their healthcare provider. As always, discussing any other drugs (over-the-counter, herbal, or prescription) with a healthcare provider is very important. Guidelines on PAH were published in the July 2004 supplement issue of the journal Chest (126:1).

Fuzeon Recommendations

Recommendations published in the journal AIDS (18, p. 1137, 2004) suggest taking the HIV medication Fuzeon only when T-cell counts are over 100 and viral load is below 100,000 copies. The risks of pneumonia and skin reactions at the injection site must also be considered when taking Fuzeon. For more information, see The CFA's Fuzeon fact sheet online at www.centerforaids.org/rita/facts/fuzeon.pdf.

Videx + Viread Interactions

The combination of the HIV medications, Videx and Viread, is linked to an increased risk of inflammation of the pancreas, according to a report in The Lancet (364, p. 65, 2004). For a variety of reasons, this combination may not be the best treatment for HIV in patients who have other options available. For more information, see The CFA's Videx and Viread fact sheets at www.centerforaids.org/rita/facts/videx.pdf and www.centerforaids.org/rita/facts/viread.pdf.

FDA Bits

Hepatitis Caution With Viread

New precautions have been added to the labeling for Viread. Though Viread has activity against both HIV and hepatitis B, the safety and effectiveness of Viread in patients co-infected with HIV and hepatitis B has not been established, according to the US Food and Drug Administration (FDA). Severe flare-ups of hepatitis B can occur in co-infected patients when they stop taking Viread. Liver function should be monitored closely for at least several months in these patients after stopping Viread.

Reyataz Update

• Boosting with Norvir is now officially recommended in patients taking Reyataz, and especially in protease-inhibitor experienced patients. Also, because of the known interactions between Reyataz and Viread, labeling changes recommend the following dose adjustments when Reyataz is taken in combination with Viread: 300 mg Reyataz boosted with 100 mg Norvir and 300 mg Viread -- all as a single daily dose with food. (Of course, another drug will also be needed to complete the regimen, in this case Emtriva would be one possibility). Reyataz without Norvir should not be given with Viread.

• As with other protease inhibitors, patients taking Reyataz and drugs to treat erectile dysfunction (for example, Viagra, Cialis and Levitra) can experience potentially dangerous side effects. When taking Reyataz and drugs to treat erectile dysfunction, the dose of the erectile dysfunction medications should be reduced.

For more information, see the CFA's fact sheet on Reyataz at www.centerforaids.org/rita/facts/reyataz.pdf.

Fewer Pills for Viracept

A new 625-mg formulation of the HIV protease inhibitor Viracept is now available. Patients taking this new version only need to take 2 pills twice daily instead of 5 pills twice a day using the previous 250-mg formulation. Viracept should be taken with a meal. For more information, see The CFA's fact sheet for Viracept at www.centerforaids.org/rita/facts/viracept.pdf.

New Fixed-Dose Combinations

In August, the Food and Drug Administration (FDA) approved 2 fixed-dose combinations of existing HIV medications. These new combinations are Epzicom (Ziagen + Epivir) from GlaxoSmithKline and Truvada (Viread + Emtriva) from Gilead Sciences, Inc. These new combinations are taken as 1 pill, once a day. They must still be taken with other HIV medications but do provide patients with simpler options for their HIV therapy.

Sculptra Approved

In August, The Food and Drug Administration approved Sculptra, an injectable filler to correct facial lipoatrophy (loss of fat) in HIV-positive people. Sculptra stimulates the production of the body's own skin proteins to help fill in where fat has been lost. Treatment with Sculptra may need to be repeated to maintain results. Common side effects include redness, swelling and bruising at the injection site, as well as the possibility at the injection sites of developing small nodules that usually can be felt but not seen. Sculptra is very expensive and community members are working with Aventis/Dermik, the manufacturer, on a patient assistance program. Most health insurance companies do not yet cover Sculptra treatment, even though it is approved as a corrective, not cosmetic, therapy.

AIDS Fraud Continues

Warning letters were issued by the Food and Drug Administration (FDA) for the products Eurocel (www.myhealthfirst.com) and Viralsol (www.viralsol.com) claiming to be therapeutic against HIV (and other diseases) with no clinical data to support the claims. These products are not approved by the FDA and may be dangerous to your health.

Back to the HIV Treatment ALERTS! October 2004 contents page.