FDA Approves Two New Drugs
In August, the U.S. Food and Drug Administration (FDA) approved two new HIV drugs, Epzicom and Truvada. See "The Buzz
The HIV protease inhibitor drug Agenerase (amprenavir) will no longer be available in 150 mg capsules. The 50 mg capsules and the liquid formulation, however, will continue to be available. The new formulation of Agenerase, Lexiva (fosamprenavir calcium), was approved by the U.S. Food and Drug Administration (FDA) in late 2003 and it was expected that people taking Agenerase might switch over to the newer and easier-to-take Lexiva.
Don't Take Crixivan With Reyataz
The FDA has made it official: you should not take Crixivan with Reyataz. When taken together, the two protease inhibitor medications might increase blood levels of bilirubin. This could indicate liver problems (although it hasn't been seen with Reyataz). Yellowing of the eyes and skin is a symptom.
Four Infants With HIV
Four Chicago infants were born with HIV in the seven months prior to September 15, according to an informal flyer distributed by a health worker with the Illinois Department of Public Health. The flyer expressed concerns that medical providers did not follow state law outlining counseling and testing procedures for pregnant women. For information regarding that law, contact the state's Perinatal Elimination Program at 1-312-814-4846.
Attorney Chip Rowen Skips Town
A reader from Atlanta called Positively Aware
about a lawyer who skipped town, leaving dozens of people with HIV stranded in their discrimination complaints or their fight for financial assistance. Chip Rowen was a founder of AIDS Legal Atlanta and well-known throughout the city for his private practice. Mary Lynn Hemphill, the Peer Counseling Program Manager for AIDS Survival Project in Atlanta, confirmed the problem. The Survival Project had regularly referred people to Rowen's private practice. Rowen has fled to Alabama, although it's not sure why. The PA
reader learned that his employer discrimination case had been dismissed by Rowen without his knowledge. The Georgia Bar Association has opened an investigation.
Government researchers have figured out part of the reason why HIV is able to hide out in the body, away from drugs that help stop it from multiplying.
In these "latent reservoirs," the virus is not multiplying but sitting around, waiting to do its damage. "The persistence of latent HIV reservoirs is one of the main barriers to the eradication of HIV infection," said principal investigator Steven Zeichner, M.D., Ph.D., in a press release. Finding a way to dump HIV out of these hiding places can give drugs a chance to get rid of the virus.
The doctors found several possible gene targets and two drugs to flush out HIV from the latent reservoirs, which current treatments do not affect. The work may also point to new possible targets for fighting the virus. The team from the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), reported their results in the August 16 Journal of Virology.
Women's Side Effects
Drug treatment can lead to side effects, but not so fast. The Women's Interagency HIV Study (WIHS) reported that after looking at several side effects, all of them were associated with the virus itself. Moreover, the odds of experiencing any of the 14 symptoms looked at were the same for women not on therapy as for those on therapy. The WIHS team reported that, "The high prevalence of symptoms among HIV-negative [high-risk] women and HIV-positive women not receiving therapy demonstrates that caution should be used when attributing the occurrence of symptoms entirely to HAART." They also reported that, "Body fat redistribution and diarrhea were most consistently associated with therapy use, because these were the only symptoms associated with both changing and stable HAART regimens." Depression was difficult to account for because it is related to both HIV infection and HIV treatment, and has non-specific symptoms such as muscle ache, fatigue and headaches.
"Our findings confirm the need to closely monitor the clinical symptoms of women on [therapy]," the team noted. "Of particular concern were symptoms such as diarrhea, nausea and/or vomiting, body fat redistribution, myalgias (muscle aches), and paresthesias (nerve damage); these symptoms were associated with a change in the therapy regimen, the majority of which involved the discontinuation of HAART [highly active antiretroviral therapy] or a component of HAART." WIHS compared 364 HIV-negative women with 1,254 HIV-positive women reporting symptoms in one six-month period of time. The findings were reported in the August 16 Clinical Infectious Diseases.
Viracept in Pregnancy
Researchers found that blood levels of Viracept were lower in pregnant women than in non-pregnant women, especially during the last trimester. The HIV drug is often used in pregnant women. Doctors from the Netherlands reported their results in the September 1 issue of Clinical Infectious Diseases
. They noted that lower blood levels might lead to higher viral loads and therefore a greater risk of HIV infection to the infant, and theoretically posing a greater risk for development of drug resistance. They suggested that Viracept levels be monitored, and if there is not enough time to get viral load to undetectable, that the starting dose of the drug be higher: 1,500 mg twice a day.
More Updates From the 15th International AIDS Conference, Held in Bangkok in July 2004
Epivir During Interruptions
Italian doctors had exciting news on HIV treatment interruptions. They found that Epivir helped keep T-cells up and viral load down during interruptions.
Instead of taking patients off all of their drugs, they had one group continue taking Epivir. The researchers found that the group of patients who continued to take Epivir (18 persons) lost half as many T-cells as the group which stopped all medications (22 persons). This was at six months. Moreover, the viral load of the Epivir group went up much less than in the stop group (at one point it was an increase of 7,000 vs. 80,000 for the no Epivir group).
Moreover, the HIV of the people on Epivir had less "replicative capacity," or the ability to infect T-cells. Basically, Epivir was crippling the virus. All of these patients had Epivir resistance (when the virus no longer responds as well to the drug). This study furthers supports the idea that Epivir resistance, the M184V mutation, does damage to the virus. The viral load may go up, but the virus is not as strong as it used to be.
Viramune and Pregnancy
The good news that the HIV drug Viramune, with or without AZT, helps reduce transmission of the virus from a pregnant woman to her infant was followed by some negative news. Studies showed that women given two Viramune pills around the time of labor had a greater risk of developing resistance to the drug. In fact, they were less able to benefit from treatment with Viramune just months later.
Researchers are working hard to overcome this problem, and one team reported some success. A team of doctors from the U.S. and South Africa found that resistance could be avoided by adding Combivir to the Viramune. (Combivir is a combination of two HIV drugs in one, AZT and Epivir.)
Half of the moms receiving only Viramune (9 out of 18) developed resistance, vs. 5% (1/20) of the women given Viramune/Combivir for four days and 13% (3/23) given Viramune/Combivir for seven days. (Why the women given an extra three days of therapy had more resistance instead of less is a mystery.)
Resistance tests were taken two weeks and six weeks after birth. The study is continuing, and Viramune will no longer be given by itself in the study.
These study results were from developing countries, where therapy is not widely available. (In the U.S., the risk of resistance should be lower if the woman is given adequate HIV therapy.)
Viramune and Diflucan
Use of the antifungal drug fluconazole (brand name Diflucan) increases blood levels of Viramune and leads to greater toxicity. Doctors in Cape Town, South Africa put 24 HIV-positive patients on fluconazole and 12 days later added Viramune. The fluconazole was continued for a total of 40 days. The participants were already taking AZT, Epivir and Ziagen (possibly as one combination pill, Trizivir). The fluconazole cut in half the clearance of Viramune out of the body. As a result, 25% of the participants developed severe liver problems, including hepatitis in two patients. The researchers said care should be taken when prescribing fluconazole with Viramune, and liver function should be monitored.
Women's Heart Disease
The Women's Intergency HIV Study (WIHS) looked for the number of heart attacks and heart failure in women on antiviral therapy. Like studies before it, this one found that heart problems result from some of the usual suspects: smoking and getting older. There was no difference between the women who took protease inhibitors and those who did not (the HIV drugs have been associated with a greater risk of cardiac troubles) and the control group of women who do not have HIV. Of the 1,564 women (1,224 positive and 340 negative), half were older than 41.7 years of age. The analysis was done for the years 2000-2002. But studies looking at risk for cardiovascular disease need to be long term to decide whether HAART and resulting cholesterol increases are indeed added risk factors.
New York, New York
Black people make up 25% of the population of New York City, but make up more than 40% of the city's population living with HIV/AIDS, and more than 50% of the deaths due to HIV/AIDS. For all groups, the prevalence of HIV/AIDS is
- Total population: 1 in 97
- Blacks: 1 in 54
- Latinos: 1 in 82
- Whites: 1 in 157
- Native American: 1 in 315
- Asian/Pacific Islanders: 1 in 972
The numbers for black men are worse: 1 in 39 are infected (it's 1 in 76 of black women).
It was thought that Viread could be toxic to the kidneys, but various reports found that renal toxicity was not common. The company-sponsored study that brought the drug to market reported no differences in renal function tests between the people taking Viread and the people in the study who didn't take it (each group had 296 participants). This was after three years of being on the medication. Also, none of the people in the Viread arm of the study dropped out because of kidney toxicity.
London doctors conducted an analysis of their patients with symptoms of kidney problems (those with a creatine level greater than 120 micro m/L). There was no difference in this group between the people taking Viread and the ones not taking it, no matter how long they've been on therapy. Moreover, of the 8% of Viread patients who did have increased creatinine (84 out of 1,058 individuals), 90% had kidney dysfunction because of some other reason.
African Americans, who tend to have more kidney dysfunction, did well with Viread for at least out to a year. This was according to a poster presentation from doctors in Houston at the University of Texas Medical School and at a private clinic. They compared 46 patients on Viread to 50 patients on AZT (Retrovir) and found no difference in kidney (renal) function. They conducted the analysis in part because, "Black race is a major risk factor for HIV-associated nephropathy (HIVAN) and other renal abnormalities seen in patients with HIV infection."
An analysis from five Kaiser clinics in California found a small increase in creatine in 199 people taking Viread, but no increase in protein in the urine.
German doctors, however, reported finding more kidney toxicity in people on Viread when using more sensitive measures. They compared 74 people on Viread with 84 people who never took the drug. None of the Viread patients, however, had kidney malfunction. Nevertheless, the researchers said care should be taken when prescribing Viread with drugs known to cause kidney toxicity.
A study reported earlier this year found renal function problems in patients on Viread followed for more than one year. The problems were associated with high blood pressure and diabetes, but not with age, sex, injection drug use or length of time on Viread.