The leading cause of death among people with HIV in the US is liver failure. When did this happen? Well, it's been this way for a few years now. Sometime just after opportunistic infection rates plummeted with the widespread use of potent antiretroviral therapy (1996–1997) and just before federal funding for HIV/AIDS began to wither (circa 2002), the AIDS community began to feel a sense of uneasiness.
For many people infected with HIV, co-infection with hepatitis C virus (HCV) is a very real problem. These 2 viruses share many features, as both are blood-borne pathogens, share certain routes of transmission, are refractory to complete eradication by currently available treatments, and have extremely high replication rates. HCV is the most common blood-borne infection and is the leading cause of chronic liver disease in the US.
Hepatitis C is a global health problem. Worldwide, approximately 170 million people have been infected with the hepatitis C virus (HCV). In the US, at least 4 million people have been infected with hepatitis C, and an estimated 250,000 are HIV/HCV co-infected. Despite a growing appreciation of the severity of the hepatitis C epidemic, gaps in hepatitis C research and policy span the continuum from prevention to liver transplantation.
Current hepatitis C treatment has many drawbacks, including significant side effects, high cost, and the need for injections of pegylated interferon. While the major clinical trials of pegylated interferon and ribavirin show about a 50% success rate in clearing the virus—deemed a sustained virologic response (SVR)—in real-life clinical settings, SVR rates are frequently lower. Moreover, treatment outcomes are poorer for African-Americans and for people with genotype 1, high viral loads, and/or HIV co-infection.
Almost 5 and a half years ago I began a new stage in my career when I started working exclusively with people living with HIV/AIDS. I was amazed at how, with great science and the humanitarian efforts of people who care, we were able to give hope to many patients that before were considered to have a fatal illness. Unfortunately, I realized rather quickly that many patients were dying from liver-related complications, despite having controlled HIV disease. The literature clearly corroborated what I was seeing in our clinic, and I became very interested in understanding the effects of hepatitis C virus (HCV) in people with HIV.
I have had HIV for 20 years and was infected with the hepatitis C virus (HCV) at least 20 years ago. So I was co-infected. The reason I say "was" is that I am no longer co-infected; that is, I don't have HCV anymore. I successfully finished my second course of treatment for HCV about 2 years ago. I eradicated HCV, or "cured" it. This essay is about me and my experience in addressing my HCV. RITA! asked me to write this article about my experience to help others in dealing with HCV. I agree that others can learn from my experience, so I hope this helps.
It's election time. Four years can be a very long time, and much has happened in the world since the last presidential election. HIV/AIDS is no exception. In the last 4 years, millions more people have become infected worldwide, and thousands of people continue to die of this disease every day. In the US, a growing population of people living with HIV/AIDS, coupled with capped or even dwindling funding to ensure them lifesaving medication and care, have put many hundreds of people on waiting lists to receive medications.
Entry. It's what must happen for HIV to infect cells. Blocking HIV entry means the virus does not get inside the T cell. The only approved medication that does this is Fuzeon, which must be injected into the skin twice daily. Even so, other HIV medications must be taken at the same time or else HIV becomes resistant to Fuzeon very quickly. So, what if there were other entry inhibitors?
Statins are a widely prescribed group of drugs used to treat high cholesterol. Sometimes, statins are also given to HIV+ individuals to treat lipodystrophy. A recent report in the Journal of Experimental Medicine (200, p. 541, 2004) describes how statins may actually fight HIV. Researchers initially did several studies in test tubes and mice showing that statins inhibited HIV infection.
A genotype test is a genetic test of your virus to see if it has any mutations. Certain mutations may make HIV medications less effective. Usually, this type of test is not done on patients who are about to start taking HIV medications for the first time. However, it may be a good idea to do so. Initial (also known as "first-line") treatment is very important because it has the best chance of suppressing HIV for a longer period of time than later treatment combinations.
Nutrition can affect a person's ability to survive with HIV/AIDS. Staying nutritionally fit is difficult for everyone, but for HIV+ people the task is even more challenging. Both HIV disease and HIV medications can have negative effects on nutrition. Unfortunately, keeping up with what is considered a healthy eating plan can be hard. However, there are some general nutrition guidelines for positive people to stay healthy. First, speak with a healthcare provider about what he or she recommends. Second, speak with a nutritionist that works with HIV+ people. A nutritionist can provide tailored eating plans that include all important vitamins and minerals.
The Houston Buyers Club is a nonprofit, 501(c)3 organization that offers nutritional supplements at a reduced cost to people living with HIV/AIDS and other chronic illnesses such as diabetes, hepatitis C, and cancer.
Salvage is an ugly word. Saying it by itself, one thinks of a large yard with rusting heaps of old appliances or dismantled cars that once had use and purpose in our modern world. Salvage can also refer to the rescue of a ship from a shipwreck, fire, or other destruction. So, how in the world could we have ever applied such a word to people living with HIV/AIDS? Perhaps it's the meaning of salvage as a verb—to save from loss or destruction. But is that any more appropriate?
On April 16 and 17 of 2004, the "Salvage Therapy II Think Tank" was held at the Baylor College of Medicine in Houston at the Texas Medical Center. This meeting was co-sponsored by The Center for AIDS (CFA) and the Forum for Collaborative HIV Research. The Center for AIDS Research (CFAR) at Baylor College of Medicine and at The University of Texas Health Science Center was a local planning partner. This meeting was dedicated to the memory of L. Joel Martinez, the founder of The CFA, who passed away in November 2003.
Panel 1 focused on ways to integrate salvage therapy research into existing networks and structures including government-sponsored clinical trials networks, observational cohorts, and industry-sponsored trials. Though the panel discussed a number of environments in which salvage research is hindered, it concluded that a solution to most of the obstacles must involve greater communication between all stakeholders at much earlier stages in the drug development process.
So you've developed a new drug that is designed to block HIV at a novel point in its lifecycle. This is not a "me-too" drug but a whole new approach. Your drug is nicely active against HIV in the test tube and didn't raise any worries in tests in mice and dogs, so it's time to move forward. You've gotten your preclinical data together and the Food and Drug Administration (FDA) has agreed to let you try it out in people without HIV to see if there is any overt toxicity. After a few studies in "healthies," you've come up with what you think is the maximum tolerated dose, and you now have some understanding about how quickly your drug is absorbed and eliminated in humans. Yet several years and several million dollars later, one big question remains: will it actually lower viral load in people with HIV?
In looking to the future of salvage therapy, consideration must be given to what treatment strategies will work best, what the salvage population will look like, what types of patients will be available for trials of new drugs, and what resources will be available to provide the new drugs. Will multi-drug resistance (MDR) of the virus occur with the treatment regimens used today? How can research provide answers for how to circumvent MDR? These were the topics discussed in Panel 3, which focused on ways to define, monitor, and treat the current salvage population and the how the salvage population will prevail over time.
Panel 4 focused on how regulatory issues were presently affecting options for salvage patients. Initial discussion noted that the numerous changes and improvements made at the Food and Drug Administration (FDA) over the last 20 years, often as a result of community input and pressure, have eliminated most of the regulatory obstacles that once existed. In short, today the FDA is not perceived as a major roadblock to the development of salvage therapy.
Since the last issue of this newsletter (October 2003), much has
happened at The CFA. Our founder, L. Joel Martinez (who stepped
down as Director in early 2003), lost his battle with cancer.
Over the December holidays, a dedicated member of our editorial
board, Norma Brown, RN, also passed away quite unexpectedly. In
the midst of these losses, we watched in disbelief as Abbott
Laboratories decided to cash in on its protease inhibitor Norvir
(commonly used in small doses to "boost" the levels of other,
less toxic protease inhibitors) by raising the price by more than
400% and ensuring that its own boosted product, Kaletra, became
the cheapest boosted protease inhibitor on the market.
Neuropathy is a painful nerve condition that affects about 1 in every 3 HIV+ patients. HIV medications sometimes known as "d-drugs" like ddI (Videx), ddC (Hivid), and d4T (Zerit) can make this condition worse. At this year's conference, several studies were presented that looked at alternative therapies to reduce the pain associated with neuropathy.
A report in the journal Biological Psychiatry (54, p. 1444, 2003) describes how researchers assessed 54 homosexual HIV+ men to study the connection between shyness (feeling inhibited in social situations) and physical health. Men who were shy had a significantly higher viral load set-point (a starting point for viral load after early or "acute" HIV infection) and had a poor response to HIV drugs compared to the HIV+ men who were not shy.
As the actual funded amounts for fiscal year 2004 were finally distributed, Houston and 41 other regions throughout the nation will have to try to provide services in the face of a 6.8% decrease from the previous year's funding levels.
While it is true that less expensive and less toxic HIV medications are needed, it can hardly be denied that what is available today is far better than what was available just a few years ago—and slowly, more treatment options are coming.