Many years before we had three anti-HIV pills (ARV) in one pill or two anti-HIV pills in one, HIVers were drowning in pill fatigue. HIVers took as many as 15 to 35 ARVs, including prophylaxis, in one day. In 2000, the light bulb went on for the medical community and pharmaceutical companies alike. They realized they could not expect HIVers to take these many drugs forever. Pill fatigue was affecting many HIVers. Pharmaceuticals and the HIV community came up with creative methods to encourage pill adherence. HIVers meanwhile coped with the multitude of drug side effects and the infamous HIV-related diarrhea.
Pharmaceutical companies realized if they developed ARVs combined into fewer pills, it made pill taking more tolerable, it improved adherence and also increased drug sales. In the US, the Food and Drug Administration (FDA) iapproved ARVs faster as HIVers’ lives depended on access to medications due to drug resistance. Drugs were approved after 28, 32 and 48 weeks of research but the long–term side effects surfaced only with long term use. (Currently FDA and European regulators have proposed extending the studies to 96 weeks.)
Pharmas competed with each other to come up with the best drug combination in one pill; this also made stock holders happy and very rich at the expense of an epidemic that killed millions of HIVers. Out of the pharmaceutical giants arose Gilead Sciences Inc. Gilead created 3 ARVs in one pill - Atripla (sustiva, FTC and Tenofovir) in 2008. This one pill created a $15 billion market” (Cortez. M. F). Atripla is a mix of Gilead’s two-drug medicine Truvada, with Bristol-Myers’s pill Sustiva. Atripla is the most widely used anti-HIV medicine.
Gilead generated $6.3 billion from HIV drugs in 2010. Selzentry, a CCR5 inhibitor, generated $128 million last year for Pfizer and its partner GlaxoSmithKline Plc. Merck, had 2010 sales of $1.1 billion for Isentress, an integrase inhibitor” (Cortez. M. F). Disease is a very lucrative business.
I believe HIVers who take these drugs deserve a share in the stock market. If physicians don’t prescribe the drugs, and HIVers don't consume the drugs, they do not sell and stock shares plunge. ASOs and NGOs struggling to maintain services for HIVers deserve 1% of the sales of these ARVs. This could lead to staff hiring and minimize staff burnout. When pharmas provide “unrestricted education grants” to ASOs, this is pocket change for karmic points. This is a very simple equation which I believe the HIV community needs to rally to!
Gilead is also conducting a comparative clinical trial, a 96 weeks study, comparing elvitegravir to Merck & Co.'s drug Isentress. And it is researching four pills in one - “a four quad” cocktail (elvitegravir, cobicstat and Truvada).
As competition stiffens for more drugs in one pill, new drugs have to be developed and researched longer, have to be safer with less adverse effects, minimal cross resistance and/or drug resistance. For years HIV clinical trials recruited newly infected persons not on treatment (the treatment naïve). Now clinical trials have to recruit HIV treatment-experienced HIVers. It has become extraordinarily hard to show a new drug is effective in a treatment-experienced HIV patient.
There are around 30 ARVs approved; the bar for new HIV drug combinations just got a lot higher. Only six ARVs were approved since 2004. As fewer combinations drugs are approved, HIVers living with multiple drug resistance have fewer options. This creates unnecessary stress, decrease in quality of life, increase in co-morbities, and fewer choices for physicians to offer HIVers.
Over the years, drug development has shrunk. The last drug approved was Intelence, three years ago. Currently there are seven drugs in the third phase of clinical research before FDA approval. In 2006 there were 100 drugs in research and now we have 60 drugs in research. Of the “60 drugs in the pipeline, ten have been discontinued or are on hold and seven are at the end of clinical development” (Cortez. M. F). As clinical trials cost millions of dollars and have to adhere to rigid standards of safety, ethics and efficacy, pharmas weigh the cost. Will a drug be worth the cost when it is finally approved after all these years of research?
The exorbitant cost of drug development pits a new drug against an existing drug to see if the new drug can out-perform the older drug. Example. “In Jan. 2010 Merck ended work on vicriviroc, a drug similar to Selzentry, in previously treated patients” after it failed to outperform existing therapies. Another anti-HIV drug apricitabine, was scrapped last May after five years of development. The reason? It had to be taken twice a day, putting it at a disadvantage to Truvada, a once a day pill.
Now one pill a day is fabulous for many HIVers. But treatment-experienced HIVers need ARVs that work against drug resistance, cross resistance - whether it is once a day or twice a day. But many pharmas choose to abandon research or not even bother with developing new drugs that are more than one a day.
While the number of HIV-infected continues to rise (currently at 33 million globally) the drug research and development sector (R &D), needs to focus on the ethics of ARV development. It is an ethical issue based on human rights; access to ARVs for treatment experienced HIVers, R & D towards a preventative and therapeutic vaccine(s), or a cure and must NOT always be based on the profit margin.
Sources: Michelle Fay Cortez , HIV Drug Development Falters as Merck, Bristol-Myers Struggle With Success. Gilead Sciences extends study of HIV drug,