by Enid Vázquez

Update from the IAS Conference

New HIV drug on the market, Selzentry

New HIV drug on the way, Isentress

AAHIVM selects new executive director

Vaccine bites the dust

Pregnancy category upgraded for Viramune

New HIV drug on the market, Selzentry

The U.S. Food and Drug Administration (FDA) in August granted accelerated approval for Selzentry (maraviroc). Selzentry is a CCR5 inhibitor (or antagonist). It blocks HIV from entering a CD4 immune cell by blocking a co-receptor called CCR5 that lies on the surface of some immune system cells. (See the Positively Aware Annual HIV Drug Guide in January/February for more information.) It is approved for people who’ve already taken HIV medications and who have detectable levels of HIV in their blood (viral load). A blood test called Trofile is needed before taking Selzentry, because Trofile helps determine whether a person has HIV that uses the CCR5 co-receptor.

The FDA reported that, “The product label includes a boxed warning about liver toxicity (hepatoxicity) and a statement in the Warnings/Precautions section about the possibility of heart attacks. …The most common adverse events reported with maraviroc were cough, fever, upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.”

Unfortunately, excitement over the drug may be somewhat waning as questions over the measurement of CCR5-tropic virus and effects of CCR5 co-receptor blocking continue. In early 24-week data, about twice as many people taking Selzentry had undetectable viral load compared with those with optimized background therapy alone (number of individuals and viral load levels not given). Research continues, including further developments with the CCR5 test.

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New HIV drug on the way, Isentress

An advisory panel to the U.S. Food and Drug Administration (FDA) in September recommended accelerated approval for a new HIV drug, Isentress (generic name raltegravir). Final FDA approval was expected in October, after Positively Aware went to press. (See also Get Sharp on page 12)

Isentress is an HIV integrase inhibitor, an entirely new class of medication to fight the virus. As such, it does not have cross-resistance with other HIV drugs already in the pharmacy.

But more importantly, Isentress has achieved tremendous stature in the eyes of treatment advocates for the results they have seen in people taking it during studies, and for the data produced by the research.

Like other new (or newer) antiviral drugs, Isentress was developed to help people on longtime HIV therapy who, for one reason or another, need a new treatment option. There are already several options for most people who are taking HIV medication for the first time. It’s the people who’ve already been on therapy, especially those on antiviral treatment for a long time or who’ve used multiple drug combinations, who need a new drug the most. They are more likely to have drug complications requiring a change; have developed resistance patterns to the medications; and developed treatment fatigue that negatively affects their ability to take medication, among other difficulties. Isentress was studied in people whose HIV has already developed resistance to three HIV drug classes.

In testimony before the FDA panel hearing, TPAN Director of Education and Advocacy Matt Sharp said, “I added Prezista and Truvada to raltegravir in the EAP [Expanded Access Program]. I achieved an undetectable viral load in less than two weeks and have experienced almost a doubling of CD4 cells, maintained now for almost a year. It appears my immune system is gaining ground as my T-cells are higher than they have been in 16 years… and recalcitrant cutaneous warts have started to literally dry up and fall off.”

For more information, see also the Annual HIV Drug Guide (January/February).

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AAHIVM selects new executive director

The American Academy of HIV Medicine (AAHIVM) in September selected a new executive director, James M. Friedman, a former longtime official with the U.S. Department of Health and Human Services (DHHS). Among its many good works, the Academy partners with TPAN and Positively Aware to answer questions from people with HIV (see Ask the HIV Specialist on page 14). The Academy, based in Washington, D.C., is an independent organization of HIV medical providers dedicated to advancing excellence in HIV/AIDS care. Through advocacy and education, AAHIVM is committed to supporting HIV clinicians and to ensuring better care for those living with HIV disease.

Friedman was with DHHS from 1973-1996, serving as Deputy Assistant Secretary for Health Planning and Evaluation (acting) as well as Deputy Director of that office. More recently, Friedman headed the health team at Hill & Knowlton Public Affairs in Washington, D.C. and served as Deputy Executive Director of The Alliance for Aging Research, a not-for-profit education and advocacy organization. He is married and has two adult children.

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Vaccine bites the dust

In mid-September, Merck and Co., Inc. and the HIV Vaccine Trials Network (HVTN) announced that vaccination in a phase 2 study of Merck’s experimental HIV vaccine is being discontinued. A scheduled interim efficacy analysis of the study found it to be ineffective at preventing new HIV infection and at reducing the amount of virus in those who became infected.

The trial, known as STEP, was an international “test of concept” trial involving 3,000 uninfected volunteers in Australia, the Americas and the Caribbean who are at high risk for acquiring HIV. Enrollment and vaccination in another phase 2 study of the vaccine that was being conducted in South Africa, known as Phambili, and two additional phase 1 trials have also been discontinued.

“This is a huge disappointment for all of us who have been involved in the search for an HIV vaccine,” said Glenda Gray, M.D., principal investigator of the HVTN-sponsored Phambili trial. “HIV is ravaging our communities, and all the scientists, participants and communities involved in HIV vaccine studies have been affected by this epidemic. The scientific community must continue the race to find a vaccine to help secure an HIV-free generation for the future.”—Keith R. Green

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Pregnancy category upgraded for Viramune

Viramune (nevirapine), an anti-HIV medication from a class of drugs known as non-nucleoside reverse transcriptase inhibitors (NNRTIs), was recently upgraded to be included in pregnancy Category B from Category C—making it the only NNRTI to achieve such status. Viramune is also the only NNRTI recommended by the U.S. Department of Health and Human Services for use in pregnant women.

Pregnancy category is one of many treatment considerations for discussion by HIV-positive women and their health care providers. Category titles range from Category A-D and Category X, with drugs in Category A considered to be the safest for pregnant women, and those in Category X considered to be completely dangerous and not recommended at all.

It is important to note, however, that life-threatening and fatal liver toxicity has occurred in patients taking Viramune, and that the drug is not recommended for women with CD4 counts with greater than 250 cells—the group considered to be at greatest risk for such toxicity. Therefore, it is still recommended that Viramune be used in this group only if the potential benefits justify the potential risks.—KRG

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