2003

PI Perspective

PI Perspective 36 -- October 2003

The Cure: We Get What We Demand: Much of the history of AIDS treatment activism can be traced back to a call for something-anything-that might change the course of HIV infection. In those early days, people typically lived only six months to a year beyond their initial diagnosis with HIV. Given such a meager outlook, people were more than happy to see the development of the first drugs that extended life for six months.
New Anti-HIV Drugs Receive FDA Approval: Three anti-HIV drugs have recently been approved by the Food and Drug Administration, including one in a new class called fusion or entry inhibitor. Each adds something unique to the arsenal of therapies to treat HIV infection.
Enfuvirtide (Fuzeon): The FDA approved enfuvirtide (Fuzeon) in spring 2003 to use with other anti-HIV drugs in children age six and older and in adults who have used anti-HIV therapy before. Enfuvirtide is in a new class of drugs called entry inhibitors.
Drug Identification Chart
FTC (emtricitabine, Emtriva): The FDA approved FTC (emtricitabine, Emtriva) in July 2003 for use by adults in combination with other anti-HIV drugs. FTC is a nucleoside analog reverse transcriptase inhibitor (NRTI). Other drugs in this class include 3TC, abacavir, AZT, Combivir, d4T, d4T XR, ddC, ddI, ddI EC and Trizivir.
Atazanavir (Reyataz): Atazanavir (Reyataz) is a protease inhibitor that received FDA approval in June 2003. Other approved drugs in this class include amprenavir, indinavir, Kaletra (ritonavir + lopinavir), nelfinavir, ritonavir and saquinavir.
Three New Drugs: Bottom Line
Three New Drugs: Buying and Access: Atazanavir, emtricitabine and enfuvirtide are available by prescription. Some states may cover these drugs through their AIDS Drug Assistance Programs (ADAP).
Facial and Limb Fat Loss: Lipoatrophy: Since the advent of potent anti-HIV therapy there have been increasing reports of changes in body composition among people living with HIV. These include increases in fat in various areas of the body (the stomach area, behind the base of the neck and/or breast enlargement) or decreases in body fat (in the face, arms and/or legs) and changes in the way the body processes fats (called lipids).
Interfering with RNA: Kill the Messenger: A number of scientific papers were published in 2002 describing the discovery of a process called RNA interference, or RNAi. The newly discovered process, whereby small strands of RNA can block the development of new genetic material, was called the "breakthrough of the year" in 2002 by Science magazine.
Interleukin-2: SILCAAT Study to Continue: In late 2002, Chiron Corporation announced its decision to shut down a large pivotal study of the drug, interleukin-2 (IL-2, Proleukin). In the days and weeks following the announcement, researchers and community activists met with the company to negotiate for the SILCAAT study to continue.
Sex, Gender and HIV: There is an ongoing dialogue within HIV research about how HIV affects men and women differently and how they may respond to therapy differently. What is often overlooked is the difference between sex and gender. Sex is based in a person's biology.

PI Perspective 35 -- January 2003

Times, They are a-Changing: The outcome of the US elections in the fall of 2002 serve as symbol of the high degree of change currently affecting the fate of people with HIV. The political and economic environment raises serious concerns about the future of treatment access, support for medical care and the overall priority given the fight against HIV within the federal government. HIV programs, with the exception of research at the National Institutes of Health, have not seen increases in the President's budget since the current administration took office, despite obvious increases in demand. The recent election gives little reason to think that will change. Not only are different attitudes affecting every aspect of HIV funding, but different people, with different agendas, have significant influence over federal HIV policy.
Anti-HIV Drug Updates - Three Drugs on the Near Horizon: The most significant new information about anti-HIV drugs offered in Barcelona concerned those drugs that are either already available or which will soon be available. This includes new information about T-20 (now called enfuvirtide or Fuzeon) and atazanavir—two drugs which will likely be approved within the next six months. Another new drug likely to be approved soon is FTC (Coviracil), a close relative of 3TC (lamivudine, Epivir), though its importance is less certain than that of enfuvirtide and atazanavir.
Drug Identification Chart
New Hope from New Classes of Therapy: For many years, researchers knew that HIV used a receptor called CD4 to find and link up with the cells it infected, though lab data long suggested that the CD4 receptor alone did not explain all aspects of the virus/cell interaction. In mid-1996, Robert Gallo and co-workers published a key finding that showed how HIV could be suppressed by a number of naturally occurring immune chemicals known as chemokines.
Complementary Corner: Interest in nutritional health products stems from a number of observations. These include documented nutritional/vitamin deficiencies even in early stages of HIV infection and malnutrition associated with increased risk of HIV disease progression. There is great controversy, however, over whether or not using supplements is always a good idea and if it provides benefits in the long run. There has also been long-standing interest in complementary and alternative medicine (CAM) approaches to managing HIV infection and various conditions associated with HIV. The CAMs most commonly used by people living with HIV are not drugs, herbs or other pharmacologic agents, but rather things like meditation, massage, energy healing, acupuncture and the like. The following article contains summary highlights of studies of nutritional health products and CAM approaches in the setting of HIV presented at the World AIDS Conference in Barcelona.
New Questions About an Old Combination - ddI + d4T: For the last several years, the combination of ddI (didanosine, Videx) and d4T (stavudine, Zerit) as a backbone of three-drug therapy has been popular both in treatment and in research. Together, the two nucleoside analog reverse transcriptase inhibitor (NARTI) drugs offered relatively high strength and fairly simple use.
Prostate Cancer Screening in African American Men: A group in New York evaluated Prostate Serum Antigen (PSA) levels among HIV-positive and HIV-negative African American men forty years of age and older.
New Uses for Tenofovir; More Questions about d4T: In fall of 2001, the drug tenofovir (Viread) was approved based on data showing its effectiveness in people who had previously developed resistance to one or more of the older anti-HIV drugs of the NRTI class (nucleoside analogue reverse transcriptase inhibitors, such as AZT, ddI, 3TC, d4T, etc.).
Interleukin-2 (IL-2, Proleukin) and Immune Function: IL-2 is an immune-based therapy that results in dramatic increases in CD4+ cell counts when used in conjunction with anti-HIV therapy. Although IL-2 has been discussed in previous issues of PI Perspective, new information warrants a further look at the product.
Human Growth Hormone for Thymus Reconstitution: The thymus is an important immune organ necessary for development of new T-cells (like CD4+ and CD8+ cells.) Without some residual thymus, immune reconstitution with a wide variety of functional CD4+ cells is not believed to be possible. Thus, the state of the thymus in HIV disease and the impact of therapies on the thymus are of great interest to those researching immune restoration approaches.
Cell Cycles, Anti-HIV Drugs and Treatment: New research regarding how and when anti-HIV drugs are effective (and ineffective) raise questions about many of the combination treatment regimens in use today. The data seem to provide additional insights into why drugs fail, and consequently suggest new strategies for improving the effectiveness of combination therapy.
In the Dog House: Chiron: Chiron Corporation, maker of interleukin-2 (IL-2), the most promising immunotherapy for HIV, for dropping the most important study of the drug without completing it.
Progress Report: Organ Transplantation in HIV: As people with HIV are living longer due to advances in HIV medicines, there is a rise in death rates from conditions not historically associated with HIV. This includes an increase in risks and rates of both liver and kidney failure, often caused by hepatitis B or C, and underlying kidney disease or HIV-related harm to the kidneys (called HIV-associated nephrotoxicity or HIVAN).
The Challenge of Barcelona: Forty million infected with HIV; five million dead in 2001. Fourteen million children orphaned. And, perhaps most startling, the prediction that seventy million people will have died by 2020 unless there is decisive intervention. The horrifying numbers that describe the international AIDS pandemic provided the backdrop for the 14^th International AIDS Conference in Barcelona. It is easy for numbers like these to paralyze those of us who live far from where the epidemic is taking its most deadly toll—in places where HIV treatment, care and prevention programs are more generally available. We wonder what we can possibly do in the face of so much suffering and death.
In the Dog House: Hoffman-La Roche: Hoffmann-La Roche, maker of saquinavir (Invirase and Fortovase) and ddC (HIVID) for setting the price of their new drug for hepatitis C, called Pegasys, even higher than that charged by Schering Plough for a similar drug.
Re-Infection: Is it a Concern for People Living with HIV?: Re-infection is a term used to describe a new or secondary infection by a virus that has already infected a person. In most viral diseases, re-infection with the same virus doesn't occur because once the immune system conquers the original viral infection, it creates immunity against that virus. Re-infection occurs almost constantly, however, in some types of infection, such as the cold or flu viruses, because each new version of those new viruses is substantially different from the last. This is why a person may develop immunity to the flu strain that is common in one year, but still be at risk from the strain that becomes dominant the next year.
Managing Nelfinavir-related Diarrhea: The use of the protease inhibitor nelfinavir (Viracept) has been associated with diarrhea. Some community-based clinics report that upwards of 80% of their clients who are using nelfinavir experience this side effect to varying degrees. While this figure is higher than what has been reported in studies, it underscores the need to prepare for and take preventive action against this side effect if you're considering the use of the drug.
We Must Have Presumed Consent: By Larry Kramer; More and more people with HIV and/or hepatitis are going to need organ transplants, particularly liver transplants. As more of us all over the world discover we are carrying one or more of these viruses, even if we are being treated for them—or particularly if we are being treated for them—the more likely it becomes that one of our organs is going to cease working effectively. And the longer we are being treated, the longer we live and the more that chance grows.

This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1980, 2003. AEGiS.