New ARV approved in the US

New ARV approved in the US

The latest Centers for Disease Control and Prevention News Update reports on a new antiretroviral drug to help drug-resistant patients, the importance of treating Chlamydia and the re-appearance of Kaposi’€™s sarcoma in the US.

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UNITED STATES: Merck’s new HIV drug wins approval

On Friday, the Food and Drug Administration approved Merck & Co.’s Isentress (raltegravir), the first drug in a new class of integrase inhibitors.

The FDA approved Isentress for patients with drug-resistant HIV who are failing their treatment regimen. The drug works by inhibiting the integrase enzyme that HIV uses to replicate.    

There are an estimated 40 000 patients in the United States who have developed resistance to three HIV drug classes. In addition, some patients do not respond to typical treatments, and Isentress may be another option for them, said Robin Isaacs, Merck’s Executive Director of Infectious Disease and HIV Vaccine Clinical Research.

It is the second new class of HIV drug approved by FDA this year. In August, the agency approved Selzentry (maraviroc), the first CCR5 co-receptor antagonist, which blocks HIV from entering white blood cells.

“We’re exploring a whole new family of medications,” said Jeff Bailey, Director of Client Services at AIDS Project Los Angeles. “That’s important for patients who believed they didn’t have options.”

It is “pretty common” for HIV/AIDS patients to be resistant to at least one treatment class, said Isaacs. “As time goes on, the chance that you become resistant becomes higher. The virus outsmarts the ability of drugs to treat it.” (Susan Todd, Star-Ledger)


UNITED STATES: Male fertility at risk from chlamydia

Chlamydia infection in men may cause genetic damage to their sperm, according to a team of US, Spanish, and Mexican researchers presenting a study at the 63rd annual meeting of the American Society for Reproductive Medicine in Washington.

In the study, researchers analyzed the DNA of sperm from 143 men who were infertile and who were diagnosed with chlamydia and mycoplasma bacterial infections.

The infected men had 3,2 times the fragmented DNA, compared with a control group of 50 fertile men.

The infected men’s sperm had 80 percent more physical abnormalities and 10 percent less mobility.

After four months of antibiotic treatment for 95 of the infected men and their partners, DNA damage to the men’s sperm declined on average by 35,7 percent, the researchers found.

During the antibiotic treatment, 12,5 percent of the couples reported a pregnancy; after treatment, 85,7 percent of the couples achieved a pregnancy.

Investigators believe the improvement stemmed from clearing the infection in men, as the damage chlamydia can cause in women is often permanent. (Ian Sample, The Guardian)


CALIFORNIA:’Gay Cancer’ makes disturbing reappearance

San Francisco doctors have reported 15 cases among gay men of Kaposi’s sarcoma (KS), a cancer-like skin disease that was prevalent among HIV patients in the 1980s.

All 15 patients, most in their 40s and 50s, are long-term HIV survivors on antiretroviral drugs. The new cases are not invasive, aggressive, or lethal, but raise disturbing questions about immune-system weaknesses of aging HIV survivors.

“This could either be the canary in the coal mine, or it could just be a collection of rare events that will continue to occur when people are given what appears to be effective treatment,” said Dr. Jeffrey Miller, an epidemiologist at San Francisco General Hospital and KS expert.

One of the first visible manifestations of the HIV epidemic 26 years ago, characterized by purple lesions, KS affected about 80 percent of HIV/AIDS patients. Many died when the disease migrated to the lungs, lymph nodes, and throat. Widespread use of antiretrovirals starting in 1995 made AIDS-related KS rare in US patients except impoverished ones with untreated HIV.

“The normal treatment for KS among HIV patients is to treat the virus and boost the immune system. But in these patients, their immune system is already boosted,” said Dr. Toby Maurer, Chief of Dermatology at San Francisco General. Maurer and colleagues revealed a cluster of nine KS cases in a letter in the Sept. 27 issue of the New England Journal of Medicine (NEJM). The patients were diagnosed between November 2004 and January 2006. Since then, more cases have surfaced.

Columbia University researchers proved in 1994 that KS is caused by a herpes virus, HHV-8. A more benign version of KS affects men in their 70s in the Mediterranean region. According to Miller, KS is still common in sub-Saharan Africa, where only one in four HIV/AIDS patients has access to antiretrovirals.

The researchers’ letter, “HIV-Associated Kaposi’s Sarcoma with a High CD4 Count and a Low Viral Load,” appeared in NEJM. (Sabin Russell, San Francisco Chronicle)