HCV New Drugs

March 8, 2012 by: Randy Burd

Source-Seeking Alpha

What is PM and we should we care about it?

The ultimate goal of PM is to utilize information about a person to rationally prescribe medicine in a tailored approach so that only the most effective treatments are used, thus increasing medical efficiency. In principle, medical practitioners have been using PM for quite some time. For example, a patient with a breast tumor that expresses the estrogen receptor (ER positive) may be given an estrogen antagonist, a drug that blocks the binding and activity of estrogen to the tumor. In contrast, there is no need to administer the antagonist to a patient when the tumor has no receptors to block. Reducing the probability of giving people treatments that are ineffective by virtue of their biological makeup not only speeds treatment time, but also has the potential to reduce side effects.

Whenever we are prescribed medicine it is because a physician has determined that the benefits of treatment will outweigh the disadvantages of the side effects. For most medicines this may not be a difficult decision because the side effects are nominal or merely discomforting. In the case of more serious diseases such as cancer, the side effects can be substantial. A drug may be the most effective and appropriate, but if the patient cannot tolerate the side effects the treatment must end early; many times these negative effects do not materialize until after treatment begins so prescribing drugs can be a process of trial and error.
The cost of treating side effects can be substantial, especially when they result from chemotherapy. For example, a study report form the 2011 European Multidisciplinary Cancer Congress indicated that the most expensive complications related to chemotherapy and/or anti-HER2 therapy were anemia, dehydration, dyspnea, and neutropenia. The individual cost per month resulting from these complications ranged from about $3,000 to $4,000. Thus, the side effects do not only interfere with the course of therapy, they can also dramatically increase the cost of treatment.

As the PM field matures, information made available to physicians before prescribing medicine is where PM will prove most advantageous. In principle, by using a blood test or biopsy, a practitioner would be able to identify if a patient would better respond to a particular drug and determine if a drug will produce side effects in a particular patient before they start treatment.

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Gilead Quad HIV drug causes fewer side effects
(Reuters) 
Full details from a pivotal trial of Gilead Sciences Inc experimental Quad HIV pill show that it caused fewer adverse side effects than the company's current three-drug pill, Atripla.
Gilead said last year that the trial had met its goal of showing that the four-drug Quad worked as well as Atripla in controlling levels of the virus that causes AIDS.

The safety data, presented here on Wednesday at the Conference on Retroviruses and Opportunistic Infections, showed that patients on Atripla had significantly higher rates of dizziness, abnormal dreams, insomnia and rash, compared with the Quad. The experimental pill did result in higher rates of nausea, 21 percent vs 14 percent.

The study found that at 48 weeks of treatment, 88 percent of Quad patients, compared with 84 percent of Atripla patients, achieved target levels of HIV virus.

Discontinuation rates were similar for both arms of the study, said Dr. Paul Sax, clinical director of the division of infectious diseases at Brigham and Women's Hospital in Boston and the study's lead investigator.
He said 1.4 percent of patients in the Quad group dropped out due to kidney abnormalities, while 1.4 percent of the Atripla group discontinued due to rash.

Dr. Sax said the median level of serum creatinine increase -- a measure of renal toxicity -- was 0.14 milligrams per deciliter for the Quad arm of the study, which was below the level of 0.4 mg/dL which would have been a safety concern.

On the issue of whether it would make sense to eventually switch patients from Atripla to the Quad, he said "it looks like a switch would be virologically safe and maybe associated with fewer central nervous system side effects."

The Quad is seen as key to Gilead's continued dominance of the market for HIV drugs. It combines experimental integrase inhibitor elvitegravir and boosting agent cobicistat with Truvada, a pill consisting of Gilead's older HIV drugs Emtriva and Viread.

Most of the company's current drug sales, which totaled $8.1 billion last year, come from Atripla, a once-daily pill that combines Truvada with Bristol-Myers Squibb's Sustiva.

With the Quad, which is currently under review by U.S. regulators, Gilead owns all of the components.
Full results from another successful trial comparing the Quad to a combination of ritonavir-boosted Reyataz, a protease inhibitor sold by Bristol-Myers, and Truvada, will be presented at the Seattle conference on Thursday.

The Food and Drug Administration is due to decide by August 27 whether to approve the four-drug HIV pill.

(Reporting By Deena Beasley; Editing by Tim Dobbyn)


Prescription Drug Coupons Are ‘Illegal Bribes?’
Source Pharmalot

That is the allegation in a series of lawsuits filed today by several union health plans against eight large drugmakers. They charge that, rather than save consumers money, prescription drug coupons illegally subsidize co-pays for brand-name meds and can actually increase health insurance premiums, which can cause consumers to hit benefit caps or lose coverage altogether.

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