POSITIVELY AWARE SEPTEMBER/OCTOBER 2011
Raising awareness to an art form
Is drug-resistant gonorrhea on the way?
Prezista to get new, non-Norvir booster
Cenicriviroc begins Phase 2b trial
Serious relationships don’t lead to safer sex
Kidney concerns for infants on Kaletra?
Raising awareness to an art form
As soon as he came out at the age of 22, artist and designer David Bromstad began meeting people with HIV. The winner of HGTV’s first Design Star competition, in 2006, and now host of his own show on HGTV, Color Splash, Bromstad says the issue of HIV is “very dear to my heart. Being in the gay community, you’re around HIV a lot,” he told Positively Aware. And so, he says it’s his honor to promote HIV testing, by teaming up with Janssen Therapeutics for the “Know Yourself: Get Tested” initiative. On September 27, for Gay Men’s HIV/AIDS Awareness Day, Bromstad will unveil a mural in Manhattan promoting testing and awareness.
“This is my time to give back,” said Bromstad. “This is a disease you don’t die from, but you can prevent it and you can treat it.”
Bromstad said people older than 30 have heard a lot about HIV, but he doesn’t see a true understanding of risk in younger people. He called the lack of fear both a good thing and a bad thing. Having seen many of his close friends deal with their HIV infection, Bromstad, who is HIV-negative, gets it. “It’s a lifelong disease with no cure, and it’s something that has to be managed and that’s no fun. It’s still medicine. It’s still side effects.”
“It’s heartbreaking,” Bromstad continued. “People don’t understand the nuances.”
At the same time, he hopes people will overcome their fear of dealing with all that, since so many people do not test for HIV until their disease has progressed. According to the Centers for Disease Control and Prevention (CDC), one out of five people with HIV in this country don’t know that they have it, and furthermore, gay and bisexual men are the only group with a rising rate of infection. “If you’re afraid to get tested, get tested anyway, so you can make it more manageable [rather] than waiting until it’s [too] late,” Bromstad said.
In a half-hour video promoting HIV awareness, “Simple HIV Facts Everyone Should Know,” face time with HIV-positive people, their medical providers, and a support group is alternated with shots of Bromstad in his studio, beautiful, colorful works and supplies lining the shelves behind him. “It’s a break from the seriousness,” he says with a laugh. That mix makes for an awareness video that is very different from the usual (it can be viewed at www.acpfoundation.org/videos.htm).
In a press release, Bromstad said, “Knowledge is one of the most powerful tools in fighting HIV, and you have to get tested to know your status. I am especially passionate about HIV testing and education because it particularly affects the community to which I’m proud to belong. I want to raise awareness of the importance of testing by using something I know well and am also passionate about: art and design. Join me by getting tested and encouraging others to do the same.”
Is drug-resistant gonorrhea on the way?
The Centers for Disease Control and Prevention (CDC) warns that “although there have been no documented treatment failures yet, untreatable gonorrhea may become a reality in the U.S.” The sexually transmitted disease is common and can cause painful urination, infertility, and increased risk of acquiring HIV.
In its July 8 issue of Morbidity and Mortality Weekly Report (MMWR), the CDC said that drug-resistant gonorrhea has been seen in men who have sex with men (MSM) in the past and then spread to the heterosexual population.
However, findings from a recent analysis signal the potential for resistance to cephalosporins, the last line of defense for gonorrhea. At a conference in Canada held in July, it was reported that a strain of gonorrhea found in Japan did not respond to any medication. The CDC says that medical providers should check to see that gonorrhea treatment is successful and report cases that do not respond to therapy.
Prezista to get new, non-Norvir booster
Tibotec Therapeutics (now known as Janssen Therapeutics), maker of the widely used HIV drug Prezista, entered into a licensing agreement in June with Gilead Sciences to develop a co-formulation of Prezista with Gilead’s experimental booster drug cobicistat. Prezista is currently taken with a booster dose of Norvir, a drug which comes with tolerability issues (such as diarrhea, stomach distress, and taste disturbance). Prezista is one of the two HIV protease inhibitor drugs recommended by U.S. guidelines for use when beginning antiviral treatment and, despite the Norvir, is considered to be generally tolerable.
Cobicistat has no activity against HIV and is used only to increase blood levels of HIV protease inhibitor drugs like Prezista. This allows for smaller or less frequent doses (such as once daily), often with fewer side effects. However, cobicistat may have a negative impact on kidney function—further research will look at this potential effect.
Tibotec also announced that the two companies are negotiating for the development and commercialization of a future single-tablet regimen (STR) combining Prezista with Gilead’s Emtriva, and its experimental drugs GS 7340 and cobicistat.
Gilead is also developing a fixed-dose “Quad” formula consisting of cobicistat, another experimental medication called elvitegravir, an integrase inhibitor, and the company’s best-selling Truvada.
Cenicriviroc begins Phase 2b trial
Tobira Therapeutics has initiated a Phase 2b clinical trial for its experimental CCR5/CCR2 inhibitor cenicriviroc (TBR-652). In addition to potent antiviral activity, cenicriviroc also has a potential anti-inflammatory effect, important for possibly controlling heart disease, dementia, and other problems. CCR5 inhibitors work by blocking HIV from entering the CCR5 receptor on immune system cells.
According to the Tobira press release, “The multi-center, double-blind, double-dummy, 48-week comparative study is designed to evaluate the efficacy, safety, and tolerability of cenicriviroc in 150 HIV 1-infected, antiretroviral treatment-naïve patients with only CCR5-tropic virus. The trial is actively enrolling patients in more than 50 sites across the United States and Puerto Rico.” Several sub-studies will assess changes in biomarkers associated with inflammation, cardiovascular function, metabolic indicators of glucose control, and immune function. For details, go to www.clinicaltrials.gov.
Serious relationships don’t lead to safer sex
Long-running research on young men who have sex with men (MSM) found an eight-times higher rate of unprotected sex in those who were in a serious relationship compared to those engaging in casual sex. Brian Mustanski, associate professor in medical social sciences at Northwestern University’s Feinberg School of Medicine, and colleagues studied 122 gay men who were between the ages of 16 and 20 when they joined the study. In a university press release, Mustanski said, “Being in a serious relationship provides a number of mental and physical health benefits, but it also increases behaviors that put you at risk for HIV transmission. Men who believe a relationship is serious mistakenly think they don’t need to protect themselves.”
The study echoes recent findings from the CDC showing the majority of HIV transmissions occur in serious relationships. Moreover, Mustanski said that 80% of young MSM who are HIV-positive don’t know it because they don’t test frequently enough. “It isn’t enough to ask your partner his HIV status,” he noted. “Instead, both people in a serious, monogamous couple relationship should receive at least two HIV tests before deciding to stop using condoms.”
According to the study, partners met online were not associated with significantly more sexual risk. The study results were published May 23 online in Health Psychology.
For articles and videos, go to www.impactprogram.org.
Kidney concerns for infants on Kaletra?
French researchers found evidence of adrenal dysfunction in newborns and preemies who were given the antiviral medication Kaletra after birth to avoid contracting HIV from their mothers. Adrenal dysfunction may interfere with blood sugar levels, among other things. The French researchers conducted the study after a warning was issued about intolerance to Kaletra in premature infants and the finding of a high level of an adrenal hormone in two French newborns who had been given the medication.
The study looked at 50 infants who were born uninfected and were given Kaletra. They were compared to a control group of 108 infants who were given other HIV medications. None of the full-term infants had symptoms, and the hormone elevation was transient. In three premature infants, however, there were life-threatening symptoms, with one experiencing cardiogenic shock (inadequate blood supply to the heart). All symptoms resolved after finishing the temporary Kaletra treatment. The researchers wrote that the finding “suggests that [Kaletra] and more generally [Norvir] boosting should be used with caution, if at all, in premature infants, and if this drug regimen is administered to full-term infants, it should be used under electrolyte monitoring.” The study was published in the July 6 issue of JAMA (Journal of the American Medical Association).
Tropism access for uninsured patients
ViiV Healthcare, in collaboration with Monogram Biosciences, has developed the Tropism Access Program (TAP) to facilitate access to tropism testing with Trofile for uninsured ADAP-eligible patients. A tropism test must be performed prior to initiating therapy with any CCR5 inhibitor such as Selzentry (maraviroc). However, the $1,800 price tag is often prohibitive. A TAP certificate, which can be obtained through a ViiV Healthcare Clinical Specialist, must be completed and presented to the health care provider at the time the blood is drawn, and the blood sample and certificate are then sent to Monogram. The provider will not be billed, but ViiV will reimburse Monogram directly, and test results will be sent to the health care provider or to a third-party laboratory when applicable.
To find out if you are ADAP-eligible, talk to a case manager or contact your state AIDS Drug Assistance Program. For a directory of state HIV/AIDS programs go to http://www.nastad.org/about/res_state_Directory.aspx. Monogram also has its own patient assistance program to help cover the cost of the Trofile test for uninsured and underinsured individuals who qualify; call 877-436-6243 or go to www.monogramvirology.com. —Jeff Berry
Ride for AIDS Chicago passes $500K
The Ride for AIDS Chicago (RFAC) raised a record-breaking sum of more than $500,000 in much-needed funds for nearly one dozen HIV/AIDS service organizations. This is the eighth year that Test Positive Aware Network (TPAN) has produced the ride, which was held July 9-10.
More than 375 riders and crew members, also a new record, converged at Northwestern University to begin a 200-mile bike ride to raise both money and awareness of HIV. The ride was the culmination of nearly six months of training and fundraising to provide lifesaving services to those living with or affected by HIV, and to continue prevention work in communities at highest risk. To become a partner of TPAN in continuing its mission to empower people living with HIV through peer-led programming, support services, information dissemination, and advocacy, go to www.tpan.com or www.rideforaids.org. The 2012 RFAC is scheduled for July 14 and 15. Registration opens Dec. 1.