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3 more dead from bacterial meningitis strain

Michael Weinstein, AIDS Healthcare Foundation, gay news, Washington Blade

Michael Weinstein, executive director of the AIDS Healthcare Foundation, said the L.A. Department of Public Health was ‘insensitive’ in responding to a meningitis outbreak.

LOS ANGELES — The strain of bacterial meningitis that infected 22 gay men and killed seven in New York City starting in 2010, continues to be a small but lethal public health risk with eight more having contracted it this year in Los Angeles County. Three died and all were men who had sex with men, the Associated Press reports.

Last week, the county’s Department of Public Health urged gay men who have had HIV or multiple partners to get vaccinated against invasive meningococcal disease, the AP said.

However, the department said the three men who died didn’t have any direct contact with each other. The disease still is considered rare and sporadic and the department is shying away from declaring any outbreak in the gay community, the AP said citing authorities.

Four of the eight people who came down with the illness had sex with other men and three were HIV positive. The three who died in February and March were 27 or 28 years old and two were HIV positive, according to the department.

Of the other five people who fell ill, four are out of the hospital and one is hospitalized but recovering, the AP said.

The agency was “insensitive” for failing to announce the deaths earlier, Michael Weinstein, executive director for the AIDS Healthcare Foundation, told the Los Angeles Daily News.

About a third of the 32 bacterial meningitis cases reported in the county since October 2012 involved men who had sex with men, the Daily News reported.

That population is most at risk right now, said Dr. Robert Bolan, medical director for the Los Angeles Gay and Lesbian Center.

The county health department is “paying attention” and acting “in a timely manner” by urging vaccinations for members of the gay community, he told the newspaper.

10
Apr
2014

Truvada’s use as HIV prevention drug raises concerns

Truvada, Gilead, gay news, Washington Blade

Drug resistance to established regimens can be a major concern. (Photo courtesy of Gilead)

NEW YORK — Debate persists in the gay community over the use of Truvada, a drug hailed as a lifesaver for many with HIV, about its use and effectiveness as a prevention technique for uninfected men who have gay sex without condoms, the AP and other news outlets report.

Many doctors and activists see immense promise for such preventive use of Truvada, and are campaigning hard to raise awareness of it as a crucial step toward reducing new HIV infections, which now total about 50,000 a year in the U.S., the AP reports.

Yet others — despite mounting evidence of Truvada’s effectiveness — say such efforts are reckless, tempting some condom users to abandon that layer of protection and exposing them to an array of other sexually transmitted infections aside from HIV.

“If something comes along that’s better than condoms, I’m all for it, but Truvada is not that,” Michael Weinstein, president of the AIDS Healthcare Foundation, was quoted as having said by the AP. “Let’s be honest: It’s a party drug.”

Truvada, produced by California-based Gilead Sciences, has been around for a decade, serving as one of the key drugs used in combination with others as the basic treatment for people who have HIV. However, the drug took on a more contentious aspect in 2012 when the Food and Drug Administration approved it for pre-exposure prophylaxis, or PrEP — in other words, for use to prevent people from getting sexually transmitted HIV in the first place, the AP said.

Since then, critics have warned that many gay men won’t heed Truvada’s once-a-day regimen and complained of its high cost — roughly $13,000 a year. Truvada’s proponents say most insurance plans — including Medicaid programs — now cover prescriptions for it, and they cite studies showing that the blue pill, if taken diligently, can reduce the risk of getting HIV by more than 90 percent, the AP said.

A town hall panel discussion on PrEP is planned for April 28 from 7-9 p.m. at the GLBT Community Center of Baltimore. Visit glccb.org for details.

10
Apr
2014

High price for Hep C drug sparks controversy

Carl Schmid, Hep C, drug, Gilead, the AIDS Institute, gay news, Washington Blade

Carl Schmid, deputy director of the AIDS Institute, said Sovaldi is expensive, ‘but this is remarkable progress and the cure rate is extremely high.’ (Photo courtesy of Schmid)

The pharmaceutical company Gilead Sciences received praise earlier this month for bringing to market a newly approved drug capable of curing the potentially fatal liver disease Hepatitis C without the serious and debilitating side effects caused by the existing drug used to treat the disease.

Experts say 20 percent of people with HIV are co-infected with Hepatitis C, which over a period of years can lead to death through liver cancer and liver failure. Physicians treating people with HIV, including Whitman-Walker Health’s medical director, Dr. Richard Elion, have called Gilead’s new drug a major breakthrough.

But at least two organizations that advocate for people with HIV and Hepatitis C have denounced Gilead for setting the wholesale price for its new drug Sovaldi at a level they consider exorbitant and which they say could lead to further escalating prices for AIDS drugs.

The AIDS Healthcare Foundation, the nation’s largest private organization providing medical services for people with HIV/AIDS, and the Fair Pricing Coalition, which advocates for affordable prices for prescription drugs for people with serious illnesses, called Gilead’s decision to set a wholesale acquisition cost of $84,000 for a 12-week treatment regimen of Sovaldi unprecedented.

“There can be no better example of the unbridled greed of the pharmaceutical industry than Gilead’s latest move: pricing its new hepatitis drug at $84,000 per 28-tablet bottle or $1,000 per pill,” said Michael Weinstein, president of AHF.

Lynda Dee, co-chair of Fair Pricing Coalition, called Sovaldi a “very safe and highly effective drug” but noted that it must be used in combination with other drugs to treat different Genotypes, or strains, of Hepatitis C.

She said that although the other drugs – pegylated interferon and ribavirin – are not as expensive as Sovaldi, the price tag for combination therapy with Sovaldi comes to $93,000 and $168,000 for various treatment regimens for a single person living with Hepatitis C.

“Gilead has set the bar dangerously high as other companies determine prices for similar Hepatitis C drugs as they enter the market,” Dee said.

In a statement released at the time the U.S. Food and Drug Administration approved Sovaldi for patient use on Dec. 6, Gilead said it had put in place a patient assistance program to ensure that people with Hepatitis C have access to Sovaldi regardless of their ability to pay for it.

The statement said the program provides assistance to “patients who are uninsured, underinsured or who need financial assistance to pay for the medicine.” The program, called Support Path, will provide Sovaldi “at no charge for eligible patients with no other insurance options,” according to the statement.

While praising Gilead for offering such a program, which is common within the pharmaceutical industry, critics say the high price for Sovaldi would likely prompt other companies to put in place similarly high pricing policies for other promising drugs about to be released for the treatment of both Hepatitis C and HIV/AIDS.

Some Wall Street analysts suggested Gilead’s price for Sovaldi may be justified when taking into consideration the amount it spent to bring such a beneficial drug to market. Bloomberg business news service reported that Gilead, which didn’t invent Sovaldi, paid $11 billion in 2011 to buy Pharmasset, Inc., the company that developed Sovaldi and other Hepatitis C drugs expected to be approved soon.

Bloomberg cited pharmaceutical industry observers who said the Hepatitis C drugs Gilead obtained through this purchase could pull in as much as $20 billion by 2020.

Clinical trials with patients monitored by the Food and Drug Administration demonstrated that Sovaldi had a cure rate of more than 90 percent for patients with the Genotype 2 strain of Hepatitis C following a 12-week regimen with the drug ribavirin. Patients with Genotype 3, another strain of Hepatitis C, had a similarly successful cure rate following a 24-week regimen of Sovaldi and Ribavirin, the trials showed.

For patients with Genotype 1 or 4 of the Hepatitis C infection, the Sovaldi treatment needed to be combined with pegylated alfa interferon, the drug of choice for Hepatitis C before the development of Sovaldi and other new drugs nearing completion of clinical trials, statements by Gilead and the FDA said. Interferon causes serious and debilitating side effects for most patients, forcing some to stop using it before the Hepatitis C virus can be eliminated, according to medical experts.

The good news, according to those monitoring Hepatitis C treatment developments, is that Gilead and other pharmaceutical companies are close to releasing other new drugs capable of effectively curing patients with the Genotype 1 and Genotype 4 strains without the need for Interferon.

“I believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of Hepatitis C,” said Dr. Ira Jacobson, chief of the Division of Gastroenterology at Weill Cornell Medical College in New York City, who served as a principal investigator in the clinical trials of Sovaldi.

Carl Schmid, deputy director of the AIDS Institute, which advocates for people with HIV, said the ability of Sovaldi to actually cure patients with Hepatitis C makes it different from HIV drugs on the market, which keep most patients healthy but cannot cure HIV/AIDS.

“Yes, it’s expensive,” he said of Sovaldi. “But this is remarkable progress and the cure rate is extremely high.”

23
Dec
2013

Price of new once-daily AIDS drug draws criticism

Truvada, Gilead, gay news, Washington Blade

(Photo courtesy of Gilead)

SAN FRANCISCO — Gilead’s new once-daily AIDS drug Stribild provides an attractive option for those with HIV who have never started a meds regiment before, but activists say the $33,000 a year price-tag will make it unattainable for most who need it.

“In the long run, the cost to Gilead to actually produce [Stribild] will be a small fraction of its selling price, which means Gilead can show restraint on…pricing and still make an enormous profit,” AIDS Healthcare Foundation president Michael Weinstein told the Huffington Post, after a massive ACT UP San Francisco demonstration at the drug maker’s headquarters over the price.

Activists are putting pressure not just on Gilead, but on lawmakers to intervene and making HIV drugs more affordable for more people.

03
Jan
2013