Researchers to test monthly vaginal ring for HIV prevention

Reuters – 17 hrs ago WASHINGTON (Reuters) - Two large clinical trials in Africa are ramping up to test the effectiveness of a vaginal ring that releases an HIV-fighting drug for a month or more, offering women at high risk a discreet way to protect themselves from the virus that causes AIDS.

The studies will test the effectiveness of a vaginal ring containing the antiretroviral drug dapivirine in thousands of women in several African countries to evaluate its ability to prevent new HIV infections and its long-term safety.

If effective, the ring will add "a long-acting, female-initiated technology to the existing toolkit of HIV prevention options," said Dr. Zeda Rosenberg, chief executive officer of International Partnership for Microbicides (IPM), a nonprofit group founded by Rosenberg which is developing the ring.

Because it only needs to be replaced once a month, the ring may help address some of the problems with getting women to consistently use vaginal gels each time they have sex, Rosenberg said during a briefing at the International AIDS Conference in Washington.

Irregular use is thought to be the reason a large study of the microbicidal gel containing the anti-HIV drug tenofovir failed to prevent infections in women in sub-Saharan Africa.

IPM has a royalty-free licensing agreement with Johnson & Johnson's Janssen unit in Ireland to use its dapivirine antiretroviral product in gel and ring forms to prevent HIV infections in low and middle income countries.

Dapivirine is part of a class of antiretroviral drugs that have long been used to treat HIV and prevent mother-to-child transmission of the virus.

NIH PARTNERSHIP

The IPM study will enroll 1,650 women aged 18 to 45, who will be randomly assigned to use the ring or a placebo in four sites in South Africa, with plans to expand to sites in Rwanda and Malawi.

It is being conducted in partnership with the U.S. National Institutes of Health-backed Microbicide Trials Network, which just started enrolling women in a separate trial called ASPIRE.

"Developing scientifically proven forms of HIV prevention that women can control is essential," said Dr. Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Disease.

"Because the vaginal ring is a long-acting intervention, it has a potential added benefit in that women may find it relatively easy to use."

The ASPIRE study will test the ring in 3,476 women aged 18 to 45 in Malawi, South Africa, Uganda, Zambia and Zimbabwe.

Women in the studies will be offered condoms and counseling on HIV prevention, and taught how to insert the vaginal ring. At monthly visits, researchers will keep track of whether women are still using the ring and give them a replacement.

Those women who become pregnant during the study will discontinue use of the ring, and their safety and that of their child will continue to be monitored.

Dr. Saidi Kapiga of the London School of Hygiene and Tropical Medicine, who is coordinating the ring study in Africa and has also conducted tests of vaginal gels for HIV protection, said there are already signs that women prefer the new option.

"It is acceptable," Kapiga told the briefing. "The fact that they use it only once in four weeks was a major advantage."

Both trials are designed to detect at least a 60 percent reduction in HIV risk, but researchers said they hope for even better results, which are expected in 2015.

"If proven to be effective, I think this will really revolutionize prevention for women," Dr. Sharon Hillier, who heads the Microbicide Trials Network at the University of Pittsburgh School of Medicine, told the briefing.

(This story corrects Rosenberg's first name to Zeda in paragraph 3 and number of women in study to 1650 in paragraph 8)

(Reporting by Julie Steenhuysen; Editing by Michele Gershberg and Eric Walsh)

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Monthly shot lowers cholesterol 66 percent: study

"A monthly injection of an experimental drug made by the US biotech firm Amgen reduced patients' cholesterol by up to 66 percent, according to a small study described at a US cardiology conference. (AFP Photo/Cesar Manso)" title

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Monthly shots of Amgen drug slash cholesterol 66 percent

Reuters – 2 hrs 10 mins ago CHICAGO (Reuters) - Monthly injections of an experimental drug from Amgen Inc slashed levels of cholesterol by up to an additional 66 percent in patients already taking statins, researchers said on Sunday, making it a potential strong rival to a similar drug being developed by Regeneron Pharmaceuticals Inc.

Amgen and Regeneron are racing to develop medicines that cut cholesterol through a new strategy, by blocking a protein called PCSK9.

In earlier studies, both drugs cut levels of "bad" LDL cholesterol by up to two thirds, although Amgen's AMG 145 had been tested in healthy volunteers taking no other cholesterol medicines, while Regeneron's REGN 727 was tested in patients with high cholesterol that also took statins.

Amgen on Sunday reported its first results from an early-stage trial of AMG 145 in patients with high cholesterol also taking statins, and impressive findings were seen in those getting injections every two weeks or every month.

In the 51-patient study, patients receiving monthly injections of AMG 145 and taking low to moderate doses of statins had up to a two-thirds reduction in LDL cholesterol by the eighth week of the study.

"We gave two doses four weeks apart and at the eighth week there was minimal tapering off" of the drug's potency, Clapton Dias, Amgen's medical services director, said in an interview. "The 66-percent reduction of LDL was maintained."

In patients receiving injections of AMG 145 every two weeks in combination with low to moderate doses of statins, LDL reductions of up to 75 percent were seen after six weeks, Amgen said.

Those taking the Amgen drug every two weeks in combination with high doses of statins had LDL reductions of up to 63 percent.

Data from the Phase 1 study were presented at the annual scientific sessions of the American College of Cardiology being held in Chicago.

Researchers on Monday are slated to release the full data from a Phase II study of REGN 727, and the findings will better enable investors to size up the pros and cons of the rival therapies.

Neither drug has shown any serious side effects so far in clinical trials.

Dias said the ability of drugs like AMG 145 to slash LDL beyond decreases attributed to statins such as Pfizer Inc's Lipitor could help enable millions of heart patients to finally get their cholesterol levels tightly controlled.

"A good 60 percent of high-risk patients in the United States are unable to meet their aggressive goals of getting LDL levels down" to target levels, Dias said, making them prime candidates for AMG 145 if it continues to do well in trials and is approved.

(Reporting by Ransdell Pierson, Editing by Gary Crosse)

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