2007—not only did many of us think we would never live to see it, but the fact that there are now nearly 30 drugs for us to choose from to construct an anti-HIV regimen is almost unfathomable. Yet here we are.
We have much to be thankful for. Many new therapies are in the pipeline, and at least three are nearing approval. One is already in expanded access, another is due to open in the next few months, and both of these are in entirely new classes of drugs. It’s being said that we will probably never again be in such good shape as far as new drugs and opportunities to combine them, at least not in the near future.
In a recent editorial in the December 15, 2006 issue of JAIDS, the authors state, “Because a large number of new antiretroviral targets (integrase inhibitors, CCR5 antagonists, maturation inhibitors) and new agents in existing classes (TMC-125) are in advanced clinical development, much research must be done to determine the optimum utilization of combination therapy with these new agents in highly treatment-experienced patients. It is possible that these new developments will change our treatment paradigms as radically as the first efficacy trials of HAART in the mid-1990s altered the face of HIV treatment in the developed world.”
So new doors are being opened, and new windows of opportunity created, in which to target and attack the virus at completely unique points along the virus life-cycle (and with more than one new drug!). This is especially important for people who have already burned through all of their current options with the standard three classes of drugs that have typically been available. Up to now, as each new drug came to market, some people were often only able to add one new effective drug to their regimen at a time, many times resulting in sub-optimal therapy.
It’s clear that we still have a tremendous amount of work ahead of us. Even today, with safer, more effective and easily tolerated therapies, people with HIV are still dying from AIDS and HIV-related diseases, cancer, heart and metabolic complications, co-infection, and liver and kidney failure. And they are dying from an unconscionable lack of foresight coupled with federal and state budget cuts. There is absolutely no reason why this past year four people died needlessly in South Carolina because they were placed on a waiting list for the state AIDS Drug Assistance Program (ADAP).
Most if not all HIV drugs still have a lot of nasty side effects or complicated interactions with other drugs (HIV and non-HIV, prescription, and over-the-counter). And they have to be taken for the rest of your life, so adherence is a crucial factor in deciding when and what to start.
That’s where this drug guide can come in handy. This is the 11th year of the Positively Aware HIV Drug Guide, and good or bad I’ve been here for every one of them. When I started working at this magazine in 1992, we didn’t have need for a drug guide because there were only two drugs approved for use at that time—AZT and ddI.
This year we have 26 drugs on our ever popular pull-out drug chart, and 29 individual drug pages. Gone are Fortovase and Hivid (ddC)—Fortovase was discontinued, and Hivid is scheduled to be taken off the market at the end of 2006 as this issue went to press. New this year is Atripla (Sustiva plus Truvada), a one pill, once-a-day combination therapy to treat HIV, a first in many ways (read all about it in this guide).
Also new to this year’s drug pages are three highly anticipated investigational new drugs: Merck’s promising integrase inhibitor MK-0518, Pfizer’s long awaited entry inhibitor maraviroc, and Tibotec’s second-generation non-nuke etravirine. These three drugs are included in the 2007 Drug Guide because they are either available or soon to be available via expanded access, with accelerated approval anticipated from the FDA within the next year or so (if all goes well with their Phase 3 studies).
So there are lots of new options available now or soon to fill up your already overflowing medicine cabinet. Unfortunately there’s not always a whole lot of resistance or interaction data to go along with these new drugs, data that’s needed in order to make informed decisions about when’s the time best to start them or how to combine them with other drugs. That’s why we require additional follow-up studies after the drugs come to market, especially among women and people of color, in order to provide information on how the drugs should be sequenced, what other drugs they are best combined with, and potential unforeseen long-term safety and toxicity issues that might arise down the road.
We should demand that pharmaceutical companies continue to focus their efforts and research on finding newer therapies which are at the same time more effective, easier to tolerate and convenient to take. And we must hold accountable our elected officials, to ensure that everyone who needs the drugs has access to them.
A lot of dedicated people worked long and hard to make this year’s guide one of the best yet. Special thanks to: Rupali Jain, PharmD; Keith Henry, MD; Cathy Olufs; Patrick Clay, PharmD; Dan Berger, MD; the folks at BioScrip in Chicago (John, Neal, and Paul); the PA editorial staff Enid Vázquez, Keith Green, Brian Agne, and Matt Sharp; and graphic designer wiz Russell McGonagle.
It’s not easy being HIV these days: everyone and everything seems to be coming at you and attacking you from every possible direction. We are at a pivotal moment in the fight against the virus. We don’t want to win the battle and lose the war. So let’s keep up the attack front, and continue to arm ourselves with the information and tools we need to live longer, stronger lives.
Food for thought for the New Year, this might be a good time for all of us to take stock, and to think about how we might be able to make a contribution in the fight against AIDS. Try to find a way that you can make life a little better for someone with HIV, or who’s at risk for contracting the virus—someone who may not be as fortunate as you are.
Take care of yourself, and each other.
Jeff Berry
Editor
publications@tpan.com |
