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 Leanne and I would like to take this time to wish everyone a Merry Christmas & Happy New 2015 Year.

This year has been a journey for all of us who belong to our network family  and it has allow for many to learn to work together.

May we never forget how lucky we are to share this season together.

God Bless,

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PMBSGN UPDATE 2014 / Positively Aware

 

FDA proposes easing restrictions on blood donations from men who have sex with menblood donation

On Tuesday the U.S. Food and Drug Administration (FDA) announced that they are recommending revising the current ban on blood donations from men who have sex with men (MSM). The changes would allow gay men and other MSM to donate blood if they haven’t had sex with another man in the past year. The current “lifetime” ban prohibits men from donating blood if they’ve had sex with any other man since 1977. “The FDA’s proposal must be seen as part of an ongoing process and not an end point,” said Ian Thompson, American Civil Liberties Union (ACLU) Legislative Representative in a statement. “The reality for most gay and bisexual men—including those in committed, monogamous relationships—is that this proposal will continue to function as a de facto lifetime ban. Criteria for determining blood donor eligibility should be based on science, not outdated, discriminatory stereotypes and assumptions.” The FDA said it intends to issue a draft guidance recommending the proposed change in policy in 2015, including an opportunity for public comment.

 

New hep C combo drug, Viekira Pak

On Friday, the FDA approved Viekira Pak for the treatment of chronic hepatitis C virus (HCV) genotype 1, including patients who have cirrhosis. Viekira Pak consists of three new drugs on the market (ombitasvir, paritaprevir, and dasabuvir) plus another medication, ritonavir, to boost blood levels of the paritaprevir. Viekira Pak, manufactured by AbbVie, can be used with or without ribavirin, but is not recommended for people with decompensated cirrhosis. The recommended dosing is two tablets once daily of ombitasvir, paritaprevir, and ritonavir plus one tablet twice daily of dasabuvir.

 

 

 

Stribild gets switch indication

The FDA last week granted a new indication (use) for the single tablet regimen Stribild. Based on combined data from Studies 115 and 121, the FDA now supports a switch to Stribild for HIV patients who have had undetectable viral load for six months while taking a different antiviral therapy, and who have no history of treatment failure.

 

 

Rapid syphilis test now more widely available

The FDA announced on December 15 that it has “granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings.” Results of the finger-prick test come back in as little as 12 minutes. According to the CDC, about 55,000 people are newly infected with syphilis in the U.S. each year, with men who have sex with men (MSM) accounting for 75% of all primary and secondary syphilis cases in 2012. The infection can increase the risk of acquiring HIV.

 

Gardasil bottle

New Gardasil

On December 10, the FDA approved Gardasil 9, a vaccine which protects against nine strains of HPV, compared to four strains for the original Gardasil. In a press release, the agency reported that “Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal, and anal cancers.”

 

Gilead sued over Sovaldi price

The Southeastern Pennsylvania Transportation Authority has filed a class action lawsuit against Gilead Sciences, claiming that the pharmaceutical’s price for its hepatitis C medication Sovaldi (sofosbuvir) violates federal antitrust laws. The price is $84,000 for 12 weeks of treatment, approximately $1,000 per pill. See the full story here.

 

 

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A Day with HIV recognized

Healthline.com has recognized Positively Aware’s anti-stigma photo campaign, A Day with HIV, as “Best On-Going HIV Awareness Campaign” for 2014. “In recognition of World AIDS Day every year, we like to honor those who are educating, empowering, and raising awareness about HIV/AIDS. Each of the eleven honorees in our second annual HIV Influencers Honors is successfully raising awareness and fighting stigma by educating others,” the organization reported. See all the awardees here.

 

 

Updated HIV prevention recommendations

According to the NIH, “A new evidence-based guideline, Recommendations for HIV Prevention with Adults and Adolescents with HIV in the United States, 2014″ is now available online. Several government agencies and nongovernmental organizations worked together to update the recommendations.

 

 

Humana cuts antiviral cost

The AIDS Institute reported that Humana Medical Plan in Florida agreed to lower the patient cost of the more costly HIV drugs from 50% to 10% co-insurance. For the HIV drugs costing less than $600, the cost will be lowered from 50% co-insurance to a $50 co-pay. The Institute noted that other insurance plans also recently agreed to decrease HIV drug costs for patients. Download the full press release here.

 

Positively Aware during this season of giving

Holiday giving

Looking to make a difference this holiday season? Consider giving to Positively Aware, the leading not-for-profit HIV/AIDS publication in the U.S. Your $30 contribution can help provide the magazine to someone who can’t afford it. A $100 dollar donation will cover the cost of a subscription for three people in need. Go to tpan.com/donate, and under “Designation” select “Positively Aware.”