One-A-Day

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Disclaimer: Some good lovin’ from time to time is also required.

Because I am blessed and in good health, I only require my fish oil supplement and my multivitamin to get me through each day. I am definitely one of the lucky ones though. For those living with AIDS it is not nearly so easy. The most effective way to slow down the ravages of AIDS has been via a triple cocktail of drugs such as Sustiva, Viread, and Emtriva.

The triple-cocktail treatment for HIV involves taking three different drugs to combat the infection. These medications are two nucleoside analog drugs, such as AZT and 3TC, and a protease inhibitor, such as Crixivan. The drugs drastically reduce the concentration of viri in the bloodstream to undetectable levels by affecting enzymes in the virus itself. The drugs do not completely eliminate every virus in the body and probably never will. It is not certain whether patients taking the drugs may still be able to transmit HIV to other people. In addition, the drugs are not a vaccine which can be prevent a person from being infected with HIV.

The total cost of the medication may be as much as $12,000 a year, although some health insurance companies cover the drugs.[Link]

Some positive news announced late today for those suffering from AIDS:

The first once-a-day AIDS pill that combines three current medicines won U.S. approval on Wednesday, offering patients a more convenient alternative to current multiple drug cocktails.

Atripla, which contains Bristol-Myers Squibb Co.’s drug Sustiva and Gilead Inc.’s medicines Viread and Emtriva, is the latest step in making it easier for AIDS patients to keep the human immunodeficiency virus or HIV in check — a process that once included dozens of daily pills.

“It’s one thing to have medicine available, but it will only be effective when people can indeed take it as they are supposed to,” U.S. Food and Drug Administration Deputy Commissioner Murray Lumpkin told reporters. [Link]

It’s all well and good that they made three pills into a one-a-day but the real test of the relevance of this new pill will be its price in India and in some of the countries in Africa that have the worst AIDS rates. Atripla will reportedly cost $1,150.88 for a 30-day supply in the U.S.

The single pill is good news for the 900,000 Americans who are living with AIDS. But the reality is that most of the 40 million people living with the disease around the world will not be able to access this medication as easily.

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p>”Another thing that is important is that it will likely be the same price as the drugs are now when sold separately, and they’re making it available to developing nations at a lower cost,” said Fauci, who has been researching AIDS since the early 1980s. “This is added good news coming on the heels of a pill developed by a company in India that has one pill containing three drugs, but you take it twice a day. It’s only for developing nations.” [Link]

As you read in the excerpt above, an Indian company developed a similar drug recently since big pharma wasn’t meeting the needs of many in the world:

Washington has barred groups receiving U.S. government funds from buying them, insisting only drugs approved by the Food and Drug Administration be used. [Link]

The fact that this new drug is by a western company, slightly better, and FDA approved will hopefully create competition in the market to drive down the price of both. In the end whatever gets the cheapest drugs to the most people will benefit everyone.

10 thoughts on “One-A-Day”

  1. There’s a third Indian 3-in-1 generic on the market, in addition to Triomune and the Ranbaxy Lab pill, which was approved on 6/30:

    Last week, the FDA approved its first twice-a-day, three-in-one pill for sale to President Bush’s $15 billion overseas AIDS initiative, which has refused to purchase the low-cost Cipla drug. The newly approved pill, produced by Indian drugmaker Aurobindo Pharma, is deemed safer than Triomune. [Link]

    It’s a combination of zidovudine, lamivudine and nevirapine. Won’t be sold in the States because it isn’t a brand name drug and probably violates patent agreements. It’s crazy that it took so long for the FDA to approve even a brand name 3-in-1 when studies have shown for years that the combination pill is a safe and cheap method of getting treatment out there. India was the first country to say “screw you” to big pharma in creating a 3-in-1 with patented drugs. The U.S. govt has until now stubbornly refused to spend any of its oversees aid money on generic brands. I wonder how many more people would have recieved some treatment if this had not been the case.

  3. First, kudos to you and Neha for covering these stories. Access to these HIV drugs is a critical issue, and India’s role in providing access is vital to this.

    However, can I be cynical for a moment? While the cocktail combined to one pill is great from a compliance perspective for patients in the US, all reports indicate that it will be priced exactly as expensively as the separate therapies are. What’s even more concerning to me is that I suspect that, by combining all three pills into one new formulation, these companies have likely extended their patents, meaning that the combination pill will stay expensive for longer.

    So Neha’s comment:

    The U.S. govt has until now stubbornly refused to spend any of its oversees aid money on generic brands. I wonder how many more people would have recieved some treatment if this had not been the case.
    • strikes me the most. Indian pharma companies are really doing a fine job of creating generics now, but they need the funding to get these drugs to the people. Given that the WHO completely missed its goal for improved access to antiretrovirals by 2005, you’d think they’d be trying to collaborate more effectively with Indian generic manufacturers.

  4. Great story.

    I’m a big believer in that daily multi-vitamin an’ essential fatty oils thing too SO just throwing this out for those interested in veggie substitutes for the fatty oils: Flaxseed oil plus Evening primrose oil (with GLA) is excellent.

  5. For a healthy Abhi ” Some good lovin’ from time to time is also required” besides Fish oil and Multivitamin every day”. And pray tell, how are you managing to get that? I wonder if you have enough time between studies, and blogging, and monitoring and banning trolls, and cooking, and cleaning and yada yada yada? Seriously, medicinal drugs are OK, but as everything comes from “Inja”, someone should find a cure for modern ailments based on Aurveda. Is there a doctor in the house? Any “Dhanvantri”, “Sushrut” or “Charak” out there. Love..Dad

  8. True, but I have yet to see a flaxseed pill that has the right levels of high quality Omega-3s and omega-6s.

  9. Â… on atripla (apologies for the length!)

    Practical reality: A single pill therapy will surely increase compliance of HIV+ patients to adhere to treatment. This will in turn increase the asymptomatic phase for the patients before escape mutants emerge against the drugs, thereby prolonging life. Prescribing, marketing, delivering, storing a single drug is also more convenient and cost effective than several drugs.

    Clinical reality: Despite the ease of administering a single drug, there are other factors to consider. As it was discussed in a previous thread, ARVs have severe side-effects and treatments need to be monitored closely to prevent more serious organ damage and possible lethal effects. There are obviously side-effects of Atripla, a comprehensive accurate list can be found, I have included the most severe complications imo below:

    Liver enzymes should be monitored in patients with known or suspected hepatitis B or C and when Atripla is administered with ritonavir or other medications associated with liver toxicity. Decreases in bone mineral density have been seen with tenofovir disoproxil fumarate. Use Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral therapy. Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including the components of Atripla. Atripla should not be given to patients with creatinine clearance below 50 mL/min. Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported in association with the use of tenofovir disoproxil fumarate, most often in patients with underlying systemic or renal disease, or in patients taking concomitant nephrotoxic agents. Atripla may cause fetal harm when administered during the first trimester to a pregnant woman. Women should not become pregnant or breastfeed while taking Atripla. Serious psychiatric adverse experiences, including severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%) and manic reactions (0.2%) have been reported in patients treated with efavirenz. Fifty-three percent of patients reported central nervous system symptoms including dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%), somnolence (7.0%), abnormal dreams (6.2%) and hallucinations (1.2%) when taking efavirenz compared to 25% of patients receiving control regimens.

    Following up with patients and proper monitoring is difficult to accomplish in North America and Europe, how can we possibly meet this challenge in third world countries? Pharmaceutical companies and the media do not debate or publicize the following concerns/thoughts much: Is providing drugs enough? Is it alright to think that we have given HIV+ people drugs to add 10 years (average) but cannot help them in 5 years when they start developing serious side-effects?

    Counter-point: 5-10 years of life may be enough for some people. e.g. most towns/villages in Uganda and Malawi are ‘dying’ because many individuals of productive age are dead leaving AIDS orphans and elders to move the country forward. Increasing the life span of individuals (ages 16-35) in such a case for 5-10 years can theoretically help the country progress better than it is currently.

    Scientific reality: HIV is a damn smart virus. The nature of a virus is to find a host to replicate in. If the conditions donÂ’t suit them, they adaptÂ… good old Darwinian theory. HIV has been able to adapt to every pressure put against it, which is key in driving the challenge of coming up with effective vaccines. Applying pressure is like tightening the bottleneck, but there is not cap on this bottle. All that is needed is for one escape mutant to trickle through and game over.
    Combination therapy is used to tighten that bottleneck, and while atripla will do that the same as its component drugs, it has the limitation of not being able to alter the therapy by tweaking the combinations as needed during the progression of the disease.

    Accessibility: Obvious fact, Atripla will still cost lots of $$$ and will not even be accessible to HIV+ patients in US. The accessibility to Canada, Europe and third world nations remains to be seenÂ… The FDA approval is important to Bristol-Myers and Gilead, because they have the rights to promote the drug in the U.S., as well as Canada and parts of Europe. Merck has the right to approve the drug in other countries, including Africa, the Middle East, and parts of Europe and Asia. Pending regulatory approval in those nations, Merck would also supply the drugs through the UN and the President’s Emergency Plan for AIDS Relief, a U.S. government initiative, said Merck spokesman Ray Kerins.

    In any case, supplying ARVs and coming up with novel drug therapies is better than nothing, but what is needed clinically is a vaccine! We need to improve current infrastructure, even in North America/ Europe, let alone third world nations. And it always comes back to education/awareness building to prevent infection in the first place.

  10. The new pill seems to be a boon to people suffering from HIV who can afford this. Research needs to be done soon to prevent and cure this disease. India with its vast resources and alternative medicines like ayurveda and homeopathy should lead the way in research. Funding is a top priority and those people who have ammased large wealth should follow gates and buffet’s footstep Everyone in their capacity should donate time and money for awareness about this killer disease. This is a good opportunity for indian biotech companies to come with some original drug delievery. Till then god help the infected people in their fight against this disease. God bless all.