Twenty-five years of fighting HIV and AIDS has taught us many hard lessons, and the learning is far from over. We’ve learned a great deal about the intersection of epidemics of addiction, violence, poverty and disease as well as the many ways in which politics and prejudice affect what is fundamentally a medical problem. So many have paid with their lives for the lessons learned that it is hard to remind ourselves that society is bettered by the experience. One aspect of the medical fight against HIV that should be carefully studied is what we have learned about confronting a new disease and how it might be applied in the future.
The 16th International AIDS Conference was held in Toronto, Canada in August 2006. Once a scientific meeting, over the years “big International” has been transformed into a massive, multi-faceted meeting encompassing nearly every aspect of the pandemic—from sessions on reducing HIV stigma, marches in support of sex workers and needle exchange to star power press conferences by Bill Gates and Bill Clinton.
Project Inform follows HIV drug development closely, in order to provide people living with HIV accurate and up-to-date information on new drugs as they work their way through the development process. HIV treatment activists use the term pipeline to refer to the collection of all experimental HIV drugs. This article provides a very brief overview of each of the most promising drugs now in the pipeline.
2006 and 2007 may one day be remembered as true watershed years for people with advanced HIV disease. The approval of Prezista (darunavir) in spring 2006 and the introduction of the integrase inhibitor MK-0518 through expanded access have brightened the picture for people who have already used many anti-HIV therapies and classes of therapy and need new options.
The success in lowering the cost in some developing countries, however, has had no positive effect on prices in the US, In fact, prices for new drugs have skyrocketed in the US in recent years, while the prices of older drugs have been raised annually. It is appropriate and necessary for health care insurers in richer countries to bear more of the cost for drugs. However, the impact of rising costs on the US health care system can't be overstated.
Drug companies typically make experimental new drugs available to patients in need prior to the completion of their approval by the FDA. This is done in the form of Expanded Access Programs (EAPs), one of the most important victories achieved by early AIDS activism. This is not, however, the only way to access free drugs.
Economic, scientific and human factors can have a profound affect on the speed with which a drug or other product moves from the laboratory shelf (or increasingly a computer model) to a product available in pharmacies or drug stores. Nonetheless, it's important for people to know what is coming through the development pipeline—as the treatment decisions made today may affect one's options available later and can, in turn, be affected by what we think will become available.
Structured Treatment Interruptions, or STIs, were the subject of a lively session at this year’s Conference on Retroviruses and Opportunistic Infections (CROI). Spurred in part by the early closure of enrollment for the SMART study, interest in STIs is higher than in many years. This article reviews the studies presented at CROI and summarize the state of current understanding on this important subject.
Some of the most important research presented at the 2006 Conference on Retroviruses and Opportunistic Infections (CROI) suggest there is a change in the air. The next few years may see the introduction of several wholly new ways of treating HIV. Entirely new classes like integrase inhibitors, monoclonal antibodies, covert nucleosides and maturation inhibitors give us a pipeline that is both robust and diverse.
Much progress has been made in AIDS treatment research, resulting in more than twenty anti-HIV drugs now available, with new combinations and easier to use formulations coming to market. Potent anti-HIV therapy has posed an ever growing list of questions about how best to use the therapies and how to manage side effects. Increasingly the concerns of availability and use of the current drugs in developing nations captures growing attention as well. In the midst of the all this, however, it's important not to lose site of the need for wholly innovative approaches to treating HIV—whether that be with the currently approved drugs or with entirely new types of therapies. This article highlights three such approaches.
On Friday, April 7, The San Francisco Chronicle published an article that raised hopes of people with HIV (“A Breakthrough AIDS Therapy in the Making?”). It focused on the experience of a single person in an ongoing study that combines gene therapy and stem cells for treating HIV. The person described in the article completed the process and has been able to stop using anti-HIV therapy for one year and counting, while remaining “undetectable” on tests that measure the level of HIV in his blood. This news is encouraging at first blush, but optimism should be tempered until more information is available.
Today, anyone who follows HIV treatment with a casual interest may get the impression that things are progressing wonderfully. A recent publication of the Pharmaceutical Manufacturers' Association asserts that 82 new medicines are in development for treating various aspects of HIV infection. Of these, 36 are antivirals, the kind of drugs that has made the most profound advances against HIV and AIDS. Surely, this sounds like good news, especially for those who have developed resistance to the current therapies.
The August 12 2005 issue of The Lancet reported on the results of a study which attempted to reduce the reservoir of cells that are latently infected with HIV. In theory, a treatment that could achieve this perfectly might result in an outright cure of HIV disease since scientists believe it is the continued presence of this reservoir that makes HIV infection a permanent condition. This study was one of series of steps researchers have taken attempting to deal with the problem of the reservoir of HIV-infected cells. Unfortunately, the magazine splashed the word CURE all over its cover, raising inappropriate expectations about what the study was able to accomplish.
As reported in PI Perspective #38, entry inhibitors are a promising new class of anti-HIV drugs. One of them, enfuvirtide, is already approved and two others (maraviroc and vicriviroc) are currently being studied. A third drug was close behind but its development was stopped in October 2005 due to serious side effects. Several others are in early stages of development.
Once-a-day Kaletra; New protease inhibitor approved by FDA: Aptivus; No extended release Zerit after all; New form of Invirase and no more Hivid; Caution and dose adjustments for Videx + Viread
Getting started: the standard Medicare benefit; Enrolling in the Medicare prescription drug benefit; Choosing a Medicare drug plan; How ADAPs will work with Medicare Part D; Getting help