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News Briefs

November/December 2000


T-20 at One Year

This experimental HIV drug is not cross-resistant to the antivirals out on the market, because it's in a brand-new class of drugs -- fusion inhibitors. What's most exciting about T-20 (generic name: pentafuside) is its study in people who have already been on lots of drugs and need new options. After a year of twice-daily injections, half the heavily-experienced people taking T-20 had a significant drop in viral load or were below 400 ("undetectable"). They took T-20 in addition to their HIV antivirals. Viral load came down from about 70,000 to around 10,000. On the minus side, only 40 out of 71 people who entered the study stayed on T-20 for the 48 weeks.

Kaletra (ABT-378/r) Newly Approved

Preliminary six-month results look good in heavily drug-experienced people. But this new three-capsule, twice-daily protease inhibitor -- approved for adults and children in September -- was taken with two nucleosides (like AZT/Epivir) plus a non-nucleoside (in this case, Sustiva). That's a combination of every antiviral drug class on the market, which limits even more options for future combinations. Then again, this was in people who don't have much choice. Overall, 69% of people on the lower dose and 82% of those on the higher dose were able to achieve undetectable viral load (under 400 copies) at 24 weeks. Those results are hard to see in heavily pre-treated people, and this was under the strict intent-to-treat analysis. The higher dose of Kaletra (generic name lopinavir) is 533mg lopinavir with 133mg ritonavir (brand name Norvir, the manufacturer's other protease inhibitor). The dose consists of three capsules, which are taken twice a day. The drug was called ABT-378/r during earlier clinical trials. This report came from a study of 57 people. Anyone planning to take Kaletra should prepare for the likeliness of nausea, diarrhea and muscle weakness.

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When taken in combination with a different non-nuke, Viramune, results were also good, but for 72 weeks (a good, long time -- making the results more reliable). People in this group had previously used at least one protease inhibitor, which stopped working for them. At 72 weeks with Kaletra, Viramune and two nucleosides, 57% were undetectable on an ultrasensitive viral load test (under 50). Altogether, 73% were undetectable (under 400 copies). T-cells went up by 154. Results are from 70 people, a small group.

Videx Not Once-a-Day

Earlier this year the Food and Drug Administration (FDA) approved once daily dosing for Videx (ddI), but now the original twice-daily dose is being urged. The once-a-day approval was based on preliminary results of a study which later found that after a year, the dose was inferior. Although once-daily dosing is still approved and available, the FDA required the manufacturer to send out a letter to healthcare providers stating the trial results and noting that twice daily dosing is "preferred." The letter says that the new dose should only be considered for people "whose management requires once-daily dosing of Videx." The company points out that the Videx group was complicated by the need for a total of four separate HIV drug doses a day, compared to three doses for the competing drug regimen.

And HIV specialist Dr. Daniel S. Berger of Chicago, who also serves as medical consultant to Positively Aware, noted that, "For patients whose viral load is optimally suppressed on once daily dosing of Videx: should they be dictated to alter dosing to twice daily based on the results of one study? Twice daily dosing on an empty stomach is often impractical for patients trying to eat frequently so that they can avoid wasting, and perhaps fat depletion -- not to mention having to take other meds with food or other meds on an empty stomach, like Crixivan." For more information, call Bristol-Myers Squibb at 1 (800) 426-7644.

IL-2 by Itself

The immune booster raises T-cells, but does it also raise HIV viral load? No, say London doctors who looked at people not on HIV antivirals. Everyone in the study (including the control group) started with at least 350 T-cells. IL-2 was given in three cycles eight weeks apart. At the end, the IL-2 group had gained 232 T-cells while the control group gained 13.

Viracept/Norvir

A "mini-dose" of 200mg Norvir added to another protease inhibitor, Viracept, seems to make blood levels of once-daily Viracept similar to levels seen when the drug is taken at its usual twice-daily dose. Viracept was given at 2,500mg. That's 10 tablets (plus two Norvir capsules), but a new Viracept formulation now in the works could reduce that to four tablets. However, fasting triglyceride (blood fat) levels were significantly higher after two weeks on the combination.

Sustiva Side Effects

Unfortunately, dose escalation did not help lessen the central nervous system effects of Sustiva (efavirenz). In fact, the dizziness, insomnia, abnormal dreams and inability to concentrate were worse. Dose escalation, where people take a smaller dose for one or two weeks before going on full dose, helps decrease the side effects of some meds.

Adherence: Bad News, Good News

Same old bad news: Unless you come close to perfection in taking your HIV meds, they will probably fail to keep your viral load undetectable. Canadian doctors reported that of people who took their doses correctly 95% of the time, 87% had less than 500 viral load "at least twice." Only 64% of the people taking the drugs correctly 90% of the time achieved this. HIV drugs are horribly unforgiving. But remember: researchers have also reported that people still benefit even when their viral load is detectable. They may actually have better health and higher T-cells counts.

On the bright side, doctors reported good results with a compact yet powerful regimen. The AIDS Research Consortium of Atlanta gave Combivir (which is made up of two drugs, AZT and Epivir) and Ziagen (abacavir) to "under-represented populations" of ethnic minorities, women and injection drug users. Seventy-two percent of the people who took their doses correctly more than 70% of the time had less than 400 viral load, and 61% had less than 40 (the ultrasensitive test). But results were even better in the group who also received "educational intervention plus counseling": at 24 weeks, 92% of them were undetectable (under 400) with only 70% adherence. The percent undetectable on the ultrasensitive test was strangely the same (62%).

Marijuana

Neither smoked marijuana nor Marinol capsules (which contain the active ingredient of marijuana) raised HIV viral load over a 21-day period, based on a small study of 63 people, who were on a Crixivan or a Viracept HIV drug combination. These results were a major accomplishment for Dr. Donald Abrams and staff, of San Francisco, who have been fighting unreasonable medical and government restrictions for years. Their goal was to help HIV patients deal with pain and wasting by doing research on the efficacy of marijuana for these conditions. They will continue to publish results in the future, such as marijuana's effect on HIV drug levels.

Hold Off on Prednisone?

Prednisone is used to treat rash caused by Viramune (nevirapine). Doctors took a look at whether it could therefore help to avoid rash (which can be serious and even fatal). One study found that using prednisone at the beginning of Viramune treatment actually doubled the incidence of rash and even made the rashes more serious, as well. But this was in contrast to an earlier study finding this to be a successful prevention effort. In fact, in the real world many people have successfully used prednisone. One clinic with a large HIV practice reported absolutely no incidence of rash when using 10mg a day for the first four weeks of Viramune. (That's amazing.)

Viramune in Pregnancy

The last issue of Positively Aware (Sept./Oct. 2000) noted that Viramune (nevirapine) was found equal to a combination of Retrovir (AZT) and Epivir (3TC) for preventing transmission -- and much more convenient and inexpensive -- but did not mention another plus for the drug. In a separate study, Viramune was able to lower transmission by a third in breast-fed babies after a year-and-a-half compared to AZT. The drugs were given at around the time of birth. The session moderator called this "tremendous news." Breastfeeding may cancel the benefit of medicine to reduce transmission. Both African and U.S. doctors conducted the HIVNET 012 study in Uganda.

Potent Drugs During Pregnancy

In the U.S., where pregnant women have greater access to potent combination therapy, these medications were again found to reduce HIV transmission to infants regardless of the mother's viral load. However, transmission does go up along with higher viral loads. The researcher noted that AZT, Epivir, Zerit (d4T) and Viramune are better at crossing the placenta than are protease inhibitors. Still, protease inhibitor combinations were better at lowering transmission than other potent combos (down to 1.1%, compared to 3.9%).

What To Do for That Fat Stomach

Therapies that raise HDL cholesterol (the "good" kind) might help avoid the expanding stomach seen in so many people on HIV meds; such therapies include the statin drugs (like Pravachol), Cardura, exercise, omega 3 free fatty acids supplements, foods high in omega 3s, and oral estrogen supplementation for post menopausal women. Nicotinic acid raises it the most (40%). A decrease in HDL helps increase brown fat. (Smoking decreases HDL.) Brown fat is more expansive than white fat, and there's a lot of it in the stomach area (and so, the bigger belly). Another area with lots of brown fat cells, that can therefore also expand is the upper back, and hence, buffalo humps. Obviously, this area needs further research. For one thing, some researchers contend that only children have brown fat.

Other researchers found more fat redistribution in people who had used Zerit (d4T) and in people who had ever used a protease inhibitor, in this case Crixivan, for more than two years. Note: simply taking Crixivan and/or Zerit without non-drug risk factors being present didn't add risk for the body fat changes. These non-drug risk factors were: having at least four years since time of HIV diagnosis; living with AIDS for at least seven years; a BMI (body mass index) change of greater than two; and age over 40 (no surprise). BMI is determined by weight divided by height. The researchers were reviewing the records of more than a thousand people with HIV.

However, bioelectric impedance analysis (BIA) and anthropometric measurements are helpful in evaluating changes in body composition such as changes in lean body mass. Loss of lean body mass leads to AIDS wasting and should be monitored regularly. BIAs can be done for free. Visit www.medibolics.com/BIAcontacts.htm.

In addition, earlier this year different studies reported less body fat changes in Latinos and African Americans than in whites, and one study also found that people with a loss of at least 1 kg BMI were at greater risk for body changes. (More than 80% of them had been studied for three years, during which their BMI changed.) Another study found that men have more lipoatrophy (loss of fat) than do women.

Nonoxynol-9 Bites the Dust

There was evidence that a microbicide containing nonoxynol-9 may increase the risk of HIV transmission, rather than decrease it, as had been hoped. Nonoxynol-9 is added to many condoms and contraceptive foams, creams, and jellies, where it is used as a spermicide. Of 1,000 sex workers in Africa using either the microbicide or a placebo (fake gel), the ones using the microbicide were 50% more likely to become infected with HIV. They were also more likely to experience vaginal lesions, which also makes HIV transmission easier. Irritation from the substance is quite common and was reported years ago. The women were counseled to use condoms.

The U.S. Centers for Disease Control issued a statement: "Given that N-9 has now been proven ineffective against HIV transmission, the possibility of risk, with no benefit, indicates that N-9 should not be recommended as an effective means of HIV prevention. . . . CDC has never recommended N-9 alone for HIV prevention, but current recommendations do emphasize the consistent and correct use of condoms, with or without a spermicide. While the level of N-9 used as a lubricant in condoms is much lower than the level found to be harmful in this study, CDC will re-evaluate this guidance as part of [an] upcoming consultation. In the interim, while N-9 will not offer any additional protection against HIV, a condom lubricated with N-9 is clearly better than using no condom at all."

One healthcare worker specializing in HIV also pointed out that this study was conducted with sex workers, who use much more N-9 and will have more physical irritation.

Selenium Deficiency May Cause More HIV Shedding

A team of Kenyan and U.S. researchers report that positive women with the mineral deficiency were three times more likely to have HIV shedding in their genital mucosa (lining), which may in turn make them more likely to infect someone else. This was after researchers accounted for other infections and for use of birth control pills.

More selenium information:

  • Less and less selenium is seen in the body as T-cells count drops.

  • People with HIV who also have selenium deficiency are 20 times more likely to die of HIV-related causes.

  • Low levels of selenium are a greater threat to survival than low T-cells.

  • Selenium deficiency poses more of a risk to survival than low levels of any other nutrient.

This information comes from a literature review on selenium in the July issue of The Lancet medical journal, quoted by John S. James, publisher of AIDS Treatment News, in the July 28 ATN issue. The Lancet report stated that, "decline in selenium occurs even in early stages of disease when malnutrition or malabsorption cannot be a factor.

More Drug Stops

Warning: This item contains tantalizing but scientifically unproven information. There are no clear answers at this time.

Dr. Anthony Fauci, director of NIAID (National Institute of Allergy and Infectious Diseases), reported on two treatment interruption trials. He calls it "Structured Intermittent Therapy," or SIT.

One group that went on therapy for eight weeks, then off for four, continued to have lower viral load after each stop. But one of the seven people in the group didn't. All started out with less than 50 viral load and their T-cells didn't change. These results are from only two or three stops (interruptions).

Members of the second group remained under 50 viral load despite being on meds for one week and off for the next. Of seven people, only one experienced detectable viral load (above 500). This group also started with less than 50 viral load to begin with, and these results are from only 14 weeks.

Then there were Dr. Franco Lori's PANDAs, people treated with hydoxyurea and Videx. In his research abstract (summary), Lori reported that none of the nine PANDAs had viral load go up to 10,000 while off treatment, while 5 of 8 people in the study taking HAART did (Highly Active Antiretroviral Therapy). However, only one of the cute little critters had a viral load above 50 to begin with, while the majority (seven) of the HAART group was above that. The stop-therapy was for eight weeks.

Among other conference reports on treatment interruptions was a Spanish report noting that 18 of 19 people off meds for three months reverted to wildtype HIV, which has no drug resistance. They all had some drug resistance before going off meds. The ability to go back to wildtype virus has been seen in other studies, and is a good thing.

PWA (person with AIDS) and advocate Jules Levin spoke from the audience at a session looking at treatment interruptions. "I'm very concerned about this. A lot of people are experimenting with this willy nilly." Researchers noted that viral load levels are followed very closely in studies and that a potential risk of this research is having drug resistance develop. Other concerns that have been raised include coming back to severe side effects all over again and the difficulty of going back on schedule with your meds (one Chicago doctor said some of her patients couldn't remember whether they were supposed to be on or off -- a finding that was also found in yet another report at the conference).

The hope for interruptions is that they'll lessen toxicity and help the body's immune system kick in to fight HIV. One U.S. study presented found significant decreases in total cholesterol, "bad" cholesterol and triglycerides (fat in the blood) in people taking a few weeks off. But body fat distribution and insulin resistance did not change.



  
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This article was provided by Positively Aware. It is a part of the publication Positively Aware. Visit Positively Aware's website to find out more about the publication.
 
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