K-PAX Canadian Trial

K-PAX, the comprehensive multivitamin/antioxidant formula for immune support, is now the subject of a randomized clinical trial in Canada. The sponsors of the Canadian trial are the Canadian HIV Trials Network and the Ontario HIV Treatment Network (OHTN). This is a high-quality scientific study, that is, it’s a double-blind, placebo-controlled randomized clinical trial–the same kind of investigation required by the FDA before approval of drugs.

The Canadian K-PAX trial is enrolling antiviral-naive HIV-infected patients, and seeks to test whether K-PAX can provide useful support for the CD4 counts of HIV(+) individuals who have not yet begun taking anti-retroviral medications. (Patients starting the study will have CD4 counts between 350 – 800.) Half the group will be randomly chosen to receive K-PAX, while the other half will receive a low-dosage type multivitamin like those sold over the counter in drugstores.

We welcome this follow-up study on the K-PAX formula. The first study, which led to wide release of the K-PAX formula, was published in 2006 and did show a significant increase in CD4 counts among those taking it, whereas other participants had no increase or even some decline. We should also mention that our predecessor organization, DAAIR, was suggesting multivitamin/antioxidant protocols for people with HIV/AIDS back in the 1990s, even before anti-retroviral therapy became generally available.

In 2006, meanwhile, NYBC developed a close equivalent of the K-PAX formula using components from its product list. This allowed the purchasing co-op to offer its MAC-Pack (Multivitamin-Antioxidant-Combination Pack) for approximately half the price of the K-PAX, a useful alternative especially for those living in localities where K-PAX was not covered by ADAP or other insurance. See www.newyorkbuyersclub.org for more details.

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Micronutrients for people with HIV: a low-cost equivalent to K-Pax

K-PAX®, the popular multi-supplement pack, was developed following Dr. Jon Kaiser’s micronutrient study that found an increase in CD4 count among HIV+ individuals using a mix of a potent multivitamin and antioxidants.* At this point, the Medicaid or ADAP formularies of many states include K-PAX®–a validation by the healthcare system welcomed by those of us who have long maintained that supplements can help to address chronic illness. Unfortunately, many people do not have access to these programs and for them, cost can be an issue. (The retail price of the “Double-Strength” K-PAX® formula is about $130/month, quite a sum for those on a budget who face extra healthcare costs.)

That’s why NYBC designed MAC Pack (for Multivitamin Antioxidant Combination), an alternative to the “Double-Strength” K-PAX® formula, based on products already available through our nonprofit co-op. Unlike K-PAX®, the parts of the MAC Pack are delivered in their original bottles, so “some assembly is required” (one reason we also stock small ziplock baggies–great for travel, too!) While NYBC’s MAC Pack is not a precise, 100% match of the K-PAX® formula, it provides a similarly comprehensive vitamin, mineral and antioxidant regimen—and at a much lower cost (about $62/month).

A few small differences between NYBC’s MAC Pack and K-PAX® should be noted:

1) Acetyl L-Carnitine: The MAC Pack actually contains more acetylcarnitine than the double-strength K-PAX®—not a bad idea, especially if you believe, as we do, that acetylcarnitine may be one of the key elements in the multivitamin-antioxidant combination. (Two a day is sufficient if you want to match the K-PAX® formula, but three or more can help if you’re dealing with neuropathy.)

2) Vitamins: The multivitamins contained in the MAC Pack have somewhat different formulas than those in K-PAX®. Taking an extra Vitamin C tab along with the regular multi would make up for one difference. And some might wish to take a bit more calcium and vitamin D3, since bone health remains a concern for people with HIV, and there is also growing recognition of the need for higher doses of D3.

3) Iron: K-PAX® only comes with iron, but for those with liver trouble, this might NOT be a good idea. With the multivitamin Added Protection, you can choose whether to take iron or not (it is available both with iron and without). Also: Ultra Preventive Beta, another Douglas Labs multi, offers a variety of food-based nutrients in addition to a standard multivitamin formula, for $3 more per month.

Note: In 2009, NYBC added to its MAC Pack offerings by introducing the Opti-MAC Pack. This version of the MAC-Pack relies on SuperNutrition’s OptiPack (iron free), which has higher amounts of B vitamins than Added Protection or Ultra Preventive Beta, and so represents a further economy in number of bottles and in cost (about $56/month). Even with these savings, it’s still a close equivalent of the K-PAX®!

For more information on NYBC’s MAC Pack or Opti-MAC Pack, or to place an order, please visit www.newyorkbuyersclub.org, or call 1-800-650-4983. (You can also order the components of the MAC-Pack or Opti-MAC Pack individually.)

REFERENCE:
* Micronutrient Supplementation Increases CD4 Count in HIV-infected Individuals on Highly Active Antiretroviral Therapy: A Prospective, Double-Blinded, Placebo-Controlled Trial. Kaiser JK, Campa AM, Ondercin JP, et al. JAIDS 2006;42[5]: 523-528.

Multivitamin Antioxidant Combination (MAC-Pack): a K-Pax alternative available in no-iron formula for those with liver impairment

In 2007, NYBC began offering an alternative to the K-Pax multivitamin-antioxidant supplement, which was added to some ADAP and Medicaid formularies following publication in 2006 of Dr. Jon Kaiser’s study that found CD4 increases in people with HIV taking a micronutrient combination supplement. A first reason for the NYBC alternative, called the MAC-Pack, was price: for those without access to ADAP or Medicaid programs, the double strength K-Pax cost of about $140/month was rather high, and NYBC as a nonprofit co-op was able to present a close equivalent for only $62/month.

But another rationale for introducing the MAC-Pack was its flexibility. In fact, because MAC-Pack uses the AMNI/Douglas multivitamins Added Protection as its core, it can be configured as a formula with or without iron. Having the option of an iron-free MAC-Pack is important especially to people with elevated liver enzymes, liver impairment, or hepatitis co-infection. Taking iron supplements is generally not recommended for this group, since processing the iron puts an extra strain on liver function.

Also note that the MAC-Pack provides somewhat more acetylcarnitine than the K-Pax, which may not be a bad idea, especially if you believe, as we do, that acetylcarnitine is probably a key element in the multivitamin-antioxidant combination. (Two tabs/day is sufficient if you’re just interested in matching the K-Pax formula, but three/day may be better especially for those dealing with neuropathy.)

For more information, see the NYBC entry:

MAC-Pack

Acetylcarnitine for peripheral neuropathy, and as a component of a multivitamin/antioxidant combination

The UK-based information website http://www.aidsmap.com provides this succinct summary of evidence for use of acetylcarnitine (also “L-acetylcarnitine” or “acetyl-l-carnitine”) for HIV-associated antiretroviral toxic peripheral neuropathy:

A deficiency in L-acetyl carnitine may also play a role in neuropathy related to HIV treatment[4]. Taking L-acetyl carnitine supplements may reverse the nerve damage caused by HIV treatment, accompanied by an improvement of pain in most patients[5]. Similar studies have also shown improvements in pain with L-acetyl carnitine treatment, with one showing sustained benefit after more than four years[6][7][8]. Although the mechanism of L-acetyl carnitine’s action is unknown, it may counteract neuropathy by acting as an anti-oxidant, preventing the damage to mitochondria. Preliminary evidence suggests that carnitine may also be effective in treating other symptoms of mitochondrial toxicity, including elevated lactic acid levels[9].

(You can retrieve the references by going to the original web page,
at http://www.aidsmap.com/cms1235526.asp)

For more information, see the NYBC entry:

Acetylcarnitine

Also note that acetylcarnitine is a principal component of NYBC’s MAC-Pack (a low-cost alternative to the K-PAX):

MAC-Pack

Supplement recommendations from Fred Walters / Houston Buyers’ Club

It was great to see an extended interview with our friend and colleague Fred Walters of the Houston Buyers Club in a recent posting on the website thebody.com.

Fred talks about his conservative Catholic background, his early vocation that took him to seminary, and his subsequent adventures as he began and nurtured the Texas-based nutritional supplements purchasing co-op for people with HIV, the Houston Buyers Club. HBC has been a beacon for so many when it comes to information about, and access to, supplements. And treatment activists that we admire a great deal, including Nelson Vergel and Lark Lands, have found a welcome forum at HBC over the years–we’re all better informed as a result.

Here’s an excerpt from the interview, in which Fred describes what he considers to be the most significant nutritional supplements for people with HIV:

I would say number one, a potent multivitamin. The top mistake people make with multivitamins is they are hypnotized by the words “one-a-day.” And there is no such thing as a potent one-a-day multivitamin for people with HIV. If you’re going to do a multivitamin you have to do several, several times a day. My favorites are Superblend by Super Nutrition and the K-Pax [KaiserPax] by Jon Kaiser [M.D., an HIV specialist in San Francisco]. Those are my two favorites. The second thing I would do is NAC, and that is a supplement that helps to increase gluthathione levels. It’s very good for the liver. The third one is fish oils, even if you don’t have high cholesterol or high triglycerides. Fish oils are real important for skin and other things in the body. They help reduce inflammation. That’s probably my biggest thing, the inflammation part. The other would be if you’re taking a high potency multivitamin you should add the selenium […]

If people are taking HIV drugs they have to take Coenzyme Q10, because what happens is that the drugs go into the body, as they’re winding their way through the cave with their guns drawn waiting to shoot at the HIV viral cells, by the time they walk up to a dead body they say, “Oh no, that wasn’t an HIV viral cell. That was a mitochondria.” And so Q10 helps to protect the mitochondria, and if you don’t protect the mitochondria in the body then you start opening yourself up to all kinds of organ and liver issues.

“Oh, how could I forget this one. […] Actually it’s getting a lot of press locally because Baylor University is studying this, but … green tea capsules. We are seeing more and more people who are doing two grams a day of green tea capsules and their T-cells are going up between 40 and 100%. Dr. Christina L. Nance is studying that at Baylor and we see that here, and today I was watching a local television show and of all days for you to call, there was a show on about food as medicine and they talked a lot about HIV, and one of the things they talked about was green tea liquid. They mentioned that it was being studied locally for HIV. So we’re not the only one on the soapbox about this. We’ve seen amazing results with that.

Read the full interview with Fred Walters at

http://www.thebody.com/content/art48991.html?mtrk=10922635

NOTE: As far as multivitamins go, NYBC has followed its predecessor DAAIR in stocking Douglas Labs multis, which are highly bioavailable (= can be easily absorbed and used by the body):

Added Protection Without Iron (a no-iron formula is recommended especially if you have elevated liver enzymes or hepatitis)

Added Protection With Iron

Ultra Preventive Beta This is a version of Added Protection that replaces the Vitamin A with beta carotene and a good mix of carotenoids–a good idea for people with any kind of liver trouble.

(NYBC also stocks the SuperNutrition multivitamins.)

Last, we have to say that a major concern for NYBC members has been the cost of supplements. That’s why in 2007 the buyers’ club began offering its MAC-Pack, which is a close equivalent of the K-PAX, but at about half price. The MAC-Pack uses the Douglas Labs Added Protection multis as its base, then adds NAC, lipoic acid, B vitamins and a substantial amount of acetylcarnitine to round out the package:

MAC-Pack (See other entries on this blog for more details.)

The MAC-Pack: a K-PAX alternative from NYBC

The New York Buyers’ Club continues to offer its MAC Pack, or Multivitamin-Antioxidant Combination pack, which is a close equivalent to the double-strength K-PAX but at about half the cost. (K-Pax is usually listed at $139; NYBC’s MAC Pack sells for $62.)

K-PAX, a multi-supplement pack, was developed following a study by Dr. Jon Kaiser that found an increase in CD4 count among HIV+ individuals using this mix of a potent multivitamin and antioxidants.
At this point, the Medicaid or ADAP formularies of many states include the K-PAX formula. Unfortunately, some people may not have access to these programs and for them cost can be an issue. That is why NYBC designed the alternative MAC-Pack, which is based on products and prices currently available through its nonprofit purchasing coop.

The MAC-Pack includes:

Acetylcarnitine: 3/day, one month supply = $15.50 (one bottle; 500mg/90)

ThiolNAC (NAC + alpha lipoic acid): 3/day, one month supply = $14.00 (one bottle; 500mg/200mg/90)

Vitamin B6 (pyridoxal-5-phosphate/P5P): 3/day, one month supply = $10.00 (one bottle; 50mg/100)

Vitamin B12 (methylcobalamin): 2/day, one month supply = $3.75 (one bottle; 1000mg/100)

Added Protection (without iron): OR Added Protection (with iron): 6/day, one month supply = $19.25

All of these components of the MAC-Pack are also available as individual items; click on links for more information.

Notes:
1) The NYBC package actually has MORE acetylcarnitine than the double-strength K-PAX. Not a bad idea, especially if you believe, as we do, that acetylcarnitine is probably one of the key elements in the multivitamin-antioxidant combination. (Two a day is probably sufficient if you are just interested in matching the K-PAX formula, but three or more can help if you are dealing with neuropathy.)

2) The multivitamins available through NYBC have somewhat different formulas than the K-PAX (see product labels available on the NYBC website for details). Taking an extra vitamin C tab along with the regular multi would make up for one significant difference. And some might wish to take a bit more calcium and vitamin D3 than Added Protection offers, as bone loss remains a concern among people with HIV.

3) K-PAX only comes with iron; for those with liver issues, this is probably NOT a good idea. With the multivitamin Added Protection, you can choose whether to take iron or not. (Please specify when ordering.)

Unexpected liver damage in people with HIV – a connection to ddI? And a potential antidote: NAC

The Canadian AIDS Treatment Information Exchange (CATIE) has reported on a small but significant study suggesting that exposure to the anti-HIV drug ddI (didanosine, Videx or Videx EC) may be the cause of otherwise unexplained liver damage in a small percentage of people taking it.

Researchers analysed health information, collected from three clinics, of HIV positive patients with unexplained and unexpected liver disease. All patients underwent extensive medical tests to try to find the cause of their problem(s). In total, the teams found 13 patients (2 females and 11 males) who had the following features in common:

  • all had higher-than-normal levels of liver enzymes
  • there were no obvious causes of liver problems
  • no hepatitis-causing viruses were detected
  • none of the participants were alcoholics
  • swollen blood vessels in the throat and abdomen
  • bleeding in the throat or abdomen
  • water retention in the abdomen
  • unintentional weight loss
  • black stools
  • exposure to ddI for at least two years

Researchers decided that all 13 patients should discontinue ddI and replace it with another suitable anti-HIV drug. Once this was done, liver enzyme levels fell and symptoms began to resolve.

Quite interesting was the researcher’s speculation about the cause of this liver damage:

[…] ddI may have decreased levels of a protective compound called GSH (glutathione) in cells. GSH is used to make enzymes that help detoxify harmful chemicals. Low levels of GSH may result in liver cells being susceptible to ddI-related toxicity.

The CATIE report goes on to discuss GSH deficiency in people with HIV, and the possibility that this deficiency may be in some cases intensified by ddI. As further noted in the report, the supplement NAC has been used to raise GSH levels. Perhaps NAC has a role to play in preventing the kind of liver damage discussed here? The CATIE reporter leaves the question open-ended:

Experiments with HIV positive people suggest that supplements of the amino acid cysteine (which is converted into GSH inside cells) can raise GSH levels in the blood. A formulation of cysteine called NAC (N-acetyl-cysteine) is used to help detoxify the liver in cases of overdose with the pain medication acetaminophen (Tylenol). To our knowledge, no clinical trials of NAC have been done in ddI users to assess its impact on GSH and liver health.

For NYBC’s view on NAC supplementation, see these entries:

NAC

PharmaNAC (an effervescent form of NAC, easy to take; made available in North America after some early research on the benefits of NAC supplementation for people with HIV in the 1990s)

ThiolNAC (NAC + alpha lipoic acid–another supplement recommended for liver support)

Note that NAC is also a key component in NYBC’s low-cost alternative to the K-Pax multivitamin/antioxidant combination pack:

MacPack