"Simply Medical" presents information on a variety of topics in HIV/AIDS treatment and research. It is published as a service to our readers and is intended for information purposes only. Treatment decisions should always be made in consultation with physicians and other healthcare professionals.

Flu Vaccines

A study testing the effectiveness of flu vaccination in people with HIV was recently published in the journal Annals of Internal Medicine. In this study, 102 people with HIV were divided into two groups, one of which received the flu vaccine while the other received a placebo or dummy shot.

The researchers reported that flu was later confirmed in ten people who received the placebo, but not in anyone who received the flu vaccine. In terms of respiratory symptoms (like runny nose and sore throat), 23 (49%) of the people who received the placebo shot got these symptoms, compared with 16 (29%) of those who took the flu vaccine.

Earlier studies have sometimes found that flu vaccines temporarily increase HIV viral load. For this reason, the researchers measured subjects' T-cell counts and viral loads when they started the study and at one month and three months after vaccination. The results showed no significant differences between people who took the flu vaccine and those who took the placebo shot. The overall conclusion of the researchers was that "routine influenza vaccination benefits patients with HIV infection." It is important to note that only thirteen people in this study had T-cell counts below 200, and the results may not necessarily be applicable to people with low T-cell counts.

The flu season is now here, and this is a good time to ask your healthcare provider about getting a flu shot.

ABT-378 "Early Access" Program

ABT-378 is a new anti-HIV protease inhibitor developed by Abbott Laboratories, the makers of the approved protease inhibitor Norvir (ritonavir). Early studies have shown that ABT-378 has a strong anti-HIV effect. It's also possible that ABT-378 will have some effect on HIV that has become resistant to other available protease inhibitors, although how strongly the drug can block resistant HIV is not yet known. Abbott is now starting a small "Early Access" program for ABT-378. This will be a very small program, allowing only 500 to 700 people in the U.S. and Europe access to the drug. To qualify for the program, people must have:

  • Over 10,000 copies HIV RNA or an opportunistic infection within the past three months
  • Less than 50 CD4+ cells for the past three months
  • Intolerance to and/or failure (i.e., viral load increases) of at least two protease inhibitors
  • The inability to construct a viable combination without ABT-378

To register patients in the program, physicians should call (888) 711-7193. In the U.S., the drug will be available through about 35 clinics, but you don't have to be receiving your medical care through those clinics to qualify for the program.

PMPA (tenofovir) -- Access Programs in Development

PMPA (new name, tenofovir) is a new anti-HIV drug in a class called nucleotide analogs. These are similar to the nucleoside analog drugs (AZT, ddI, ddC, d4T, 3TC, and Ziagen). Early studies of PMPA have shown that it has a strong anti-HIV effect, and HIV that is resistant to other anti-HIV drugs may often be blocked by PMPA. These results suggest that PMPA might offer a good treatment option for people who are resistant to available anti-HIV drugs.

A group of community activists called the Coalition for Salvage Therapy has been trying to obtain access to PMPA for people with AIDS who need new treatments. Negotiations with PMPA's manufacturer, Gilead Sciences, have led to the possibility of a "compassionate use" program that will make PMPA available to a limited number of people in urgent need. The most recent news is that a small program may start in late 1999, along with an open-label study at thirty clinical trial sites around the U.S.. "Open-label" means that anyone joining the study will know that they are getting PMPA, and not a placebo or dummy pill. Since starting a new combination of anti-HIV drugs is known to be much better than starting one new anti-HIV drug, priority may be given to people who are also getting ABT-378 from the Abbott expanded access program described above.

Although a specific phone number for the PMPA program has not yet been set up, information and updates should be available soon at the main Gilead Sciences toll-free number, 1-800-GILEAD5 (445-3235).

Lactic Acidosis Warning

A recent report from the Food and Drug Administration has sounded a warning about a potential HIV drug side effect called lactic acidosis. Lactic acidosis is a serious, potentially fatal, liver problem that can be caused by NRTI-type anti-HIV drugs (these are AZT [Retrovir], ddI [Videx], ddC [HIVID], d4T [Zerit], 3TC [Epivir], abacavir [Ziagen], and AZT+3TC [Combivir]).

The FDA reported on sixty cases at a recent conference. Symptoms included nausea, vomiting, pain in the abdomen (stomach area), weight loss, weakness, and abnormal (often rapid or difficult) breathing, especially after exercising. Increases in blood measurements called CPK, amylase, and lipase were also reported, although changes in these blood tests can result from other conditions apart from lactic acidosis. Lactic acid blood testing is another measure that can provide warning of lactic acidosis, according to another study presented at the same conference.

Over half of the sixty cases reported by the FDA resulted in death, showing how serious lactic acidosis can be. It is vitally important that the problem be diagnosed quickly and NRTI therapy stopped. Women, especially those above their ideal body weight, are at particularly high risk for this side effect, according to the FDA study.

Agenerase (amprenavir): Sulfa reaction warning

Agenerase (also known as amprenavir) is a recently approved anti-HIV drug in the class called protease inhibitors. It is not widely known that Agenerase contains a substance called sulfa to which some people are allergic. A much better-known sulfa drug is the anti-PCP drug Bactrim/Septra, and it is well-known that some people can't take Bactrim because of an allergic reaction that usually causes a severe skin rash.

In Agenerase studies, about one in four people got a skin rash, but most were able to continue taking the drug while the rash got better. About one in 100 developed a more serious, grade 3 or 4 rash. One person developed a much more severe allergic reaction called Stevens-Johnson Syndrome, or SJS. SJS can be life-threatening, and Agenerase should be permanently stopped if this reaction develops.

Ken Fornataro is Executive Director of the AIDS Treatment Data Network. For more information, call (800) 734-7104. Affiliation is for purposes of identification, not representation.

Back to the December 1999 Issue of Body Positive Magazine