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Odds and Ends

March 2001

FDA Approves New 3-in-1 Drug Trizivir

{ ABV + 3TC + AZT } = Trizivir

The Food and Drug Administration (FDA) has approved Trizivir, a three-drug combination tablet that includes standard doses of abacavir (Ziagen), 3TC (Epivir) and AZT (Retrovir) in a single pill. The new pill allows for easier dosing of three-drug therapy: only one pill twice daily.

In people who have not taken anti-HIV therapy before, this combination has shown short-term benefit comparable to that of regimens with protease inhibitors. With the added benefit of many fewer pills, this should also improve adherence.

However, results from one study showed that people with a viral load over 100,000 copies/mL did not respond as well to abacavir/3TC/AZT as those who used a three-drug regimen including a protease inhibitor. This difference was not seen in a second similar study.

The usual precautions about allergic reactions (called hypersensitivity) to abacavir also need to be considered for Trizivir. People who weigh less than 100 pounds should talk to their doctors about safety concerns associated with weight before taking the drug.

FDA Issues Warning for New Drug Lopinavir

Last September, the FDA approved the new protease inhibitor Kaletra (formerly ABT-378). The drug contains lopinavir plus a small amount of ritonavir (Norvir), which helps boost lopinavir levels in the blood.

A warning has been issued about the possibility of developing pancreatitis (inflammation of the pancreas) while on this drug. Less than 1% of the people in studies including of lopinavir developed pancreatitis.

It's not possible to definitively say that people developed pancreatitis from taking lopinavir, as some were also taking other drugs known to cause pancreatitis like pentamidine, ddI (didanosine, Videx) and d4T (stavudine, Zerit). Additionally, some volunteers had very high triglyceride levels, which can result in pancreatitis. Nevertheless, people on lopinavir should carefully check their amylase levels (a marker for pancreatitis) and work with their doctors to identify early warning symptoms.


Liver Side Effects

loss of appetite
high liver enzyme levels

swollen liver
liver failure

New Nevirapine Warning

Nevirapine (Viramune) is known to cause hypersensitivity in up to 25% of people taking the drug. In less than 1%, these reactions are severe. Severe liver damage has also been reported in people taking nevirapine. New recommendations enforce the need for careful monitoring when taking nevirapine -- especially during the first twelve weeks of use -- when severe side effects, if they are going to occur, are most likely.

CDC Reports HPV as Most Common STD

The Centers for Disease Control and Prevention recently reported that nearly 18% of women and 8% of men in the U.S. carry the human papillomavirus (HPV). The virus causes more than 95% of cases of cervical cancer, and the HPV-16 strain causes half of them. According to the research, the highest rates of HPV-16 infection were found among African American women aged 20 to 29, the same group of women hardest hit by HIV infection.

HPV-related symptoms include genital warts and early stage anal and cervical dysplasia. These symptoms can be treated, and regular monitoring is important to catch them early.

While some people may not choose to treat anal/genital warts because of high recurrence rates, monitoring and treating the condition is critical should it turn pre-cancerous. Left untreated, these conditions can worsen, especially in people with a weak immune system. Thus, this study is an important reminder for the importance of regular cervical Pap smears that can detect HPV-related dysplasia -- leading to its treatment and lowering of anal and cervical cancer as appropriate.

Remember, positive women should get a Pap test every six months, and more often if something is wrong. Read Project Inform's gyn conditions for more details.

Expanded Access Program Begins for Tenofovir

Gilead Sciences, the developers of a new nucleotide analogue, tenofovir (PMPA), started a small expanded access program in January. The most important use of this drug, for now, will probably be in people who have developed resistance to several of the NRTI drugs, like d4T (Zerit) and AZT (Retrovir), and need something new to shore up their combination therapy. It is less clear whether the drug will compensate for protease inhibitor failure. The initial program will begin small and expand during 2001 as drug supplies increase.

To qualify, people must have all of the following:

  • Over 10,000 copies HIV RNA and CD4+ cell counts below 100 or CD4+ cell counts below 200 and an opportunistic infection within the past three months;

  • Intolerance to and/or viral load increases to at least two protease inhibitors or one protease inhibitor and one NNRTI (for a list of the names and types of anti-HIV drugs, call Project Inform's Hotline, 1-800-822-7422); and

  • Unable to construct a viable drug combination without tenofovir.

To register patients in the program, physicians should call 1-800-445-3235. As more drug supplies become available, the criteria to qualify will change.

Back to the Project Inform WISE Words March 2001 contents page.

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This article was provided by Project Inform. It is a part of the publication WISE Words. Visit Project Inform's website to find out more about their activities, publications and services.