Yearly Archives: 2013

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Co-Pay Programs for HIV Antiviral Medications

A unique industry public-private partnership aimed at streamlining access to HIV medicines through the use of a Common Patient Assistance Program Application developed in partnership with the Department of Health and Human Services (HHS) and 6 industry partners. This form will allow you to apply to multiple HIV manufacturer patient assistance programs through a single application. You can access the common application form here: common application form. All of the information you need to apply for assistance for HIV medicines offered by the 7 participating patient assistance programs is included in this one application. These programs offer assistance to people with private health insurance for the co-payments required to obtain HIV drugs at the pharmacy. Some companies offer co-pay assistance for all of their drugs, including non-HIV drugs.

http://fairpricingcoalition.org/projects/co-pay-programs-for-hiv/.
 
ABBOTT
 
Drugs covered: Kaletra, Norvir Contact Information: 800-222-6885, or go to the product websites (e.g. www.kaletra.com) Program Details: The co-pay assistance covers the first $200 per Kaletra prescription per month, and the first $50 per Norvir prescription per month. Currently, a person must reapply for the program each year.
 
BOEHRINGER INGELHEIM (BI)
 
Drugs covered: Viramune XR Contact Information: The BI co-pay card is distributed by health care providers, HIV service providers and pharmacies only. Program Details: The co-pay assistance starts at the first dollar paid by the consumer. Specifically, during the first month of the treatment the program covers the first co-pay for the Viramune IR lead-in dose and the second two weeks of Viramune XR. Thereafter, the program covers up to $100 per-month of your Viramune XR co-payment for 12 months in total. The program does not cover Aptivus prescriptions, nor does it cover Viramune IR after the first month. Previously a person needed to reapply for the program each year, however those who plan to or are currently enrolled in the co-pay program are now covered through December, 2013.
 
BRISTOL-MYERS SQUIBB (BMS)
 
Drugs covered: Atripla, Reyataz and Sustiva Contact Information: 888-281-8981 for Sustiva and Reyataz or 866-784-3431 for Atripla or go to the product websites (e.g. www.sustiva.com) Program Details: The program covers the first $200 per-month of your co-payment for all BMS HIV products. Currently, a person must reapply for the program each year.
 
GENENTECH/ROCHE
 
HIV Drugs covered: None Contact Information: None Program Details: No program, might cover co-pays through their patient assistance program.
 
GILEAD SCIENCES
 
Drugs covered: Atripla, Complera, Emtriva, Stribild, Truvada, Viread Contact Information: 877-505-6986 or go to product websites (e.g. www.truvada.com) Program Details: The program covers the first $400 per-month of your co-payment for Atripla, Complera, and Stribild; and the first $200 per month of your co-payment for Emtriva, Truvada and Viread. The program automatically renews annually for enrolled patients.
 
GLAXOSMITHKLINE See ViiV Healthcare
 
JANSSEN THERAPEUTICS (formerly Tibotec Therapeutics)
 
Drugs covered: Edurant, Intelence, Prezista Contact Information: 866-961-7169 or go to product websites (e.g. www.prezista.com). You can also get all of the relevant information or forms including an instant savings card at www.janssentherapeutics.com. Program Details: After paying the first $5 of your co-payment, there is no limit on the amount of the remaining co-pay Janssen will cover. Currently, you must reapply for the program each year.
 
MERCK & CO
 
Drugs covered: Isentress Contact Information: 888-204-3713 or www.isentress.com Program Details: The program covers the first $400 per-month of your co-payment for Merck HIV products. Currently, a person must reapply for the program each year.
 
PFIZER See ViiV Healthcare
 
ViiV HEALTHCARE (formerly GlaxoSmithKline and Pfizer)
 
Drugs covered: Combivir, Epivir, Epzicom, Lexiva, Rescriptor, Retrovir, Selzentry, Trizivir, Viracept and Ziagen. Contact Information: Call 1-877-844-8872. Patients can use their current or new card for both Pfizer and GSK drugs, now under one umbrella at ViiV Healthcare. You can get the card from your provider or print out the card online at www.mysupportcard.com. Program Details: The program covers the first $100 per-month of your co-payment on each ViiV prescription. Currently, you must reapply for the program every two years.
 
ViiV just announced on Jan 28, 2013 they are increasing the maximum out-of-pocket co-pay costs they will cover to $200. They are updating the website mentioned above s its not available right now. In the interim, new cards can be obtained through healthcare providers and pharmacists, or by calling the ViiV Healthcare Customer Response Center at 1-877-844-8872. New cards will need to be activated before they can be used by calling 1-855-208-3317

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Free condoms to be available in local high schools

By Jane Northrop

Pacifica Tribune Staff Writer
The Jefferson Union High School District board of trustees unanimously approved making condoms available in the high schools last Tuesday.

The conceptual policy is being drafted by staff and will be presented to the board for final approval at a later date.

The current policy allows students to receive condoms, but only if given to them by a licensed health care practitioner. That means students must make their way to the Daly City Youth Health Center.

The new policy will make it easier for the students to get condoms through the special services counselors at each of the schools.

The board members voted to allow special services counselors to dispense condoms, provided the student has successfully completed the JUHSD health class.

In 2009, the Daly City Youth Health Center, with the blessings of the JUHSD board of trustees, initiated a pilot program making condoms available at Thornton Continuation High School.

When that policy was initiated, Kimberly Gillette, director of the Daly City Youth Health Center, said the Thornton students filled out a survey about sexual activity. All but one said they were already sexually active.

“Condom availability does not increase sexual activity, but it may make them more likely to use a condom,” she said.

Scott Cuyjet, a nurse practitioner at the DCYHC, said students have told him they are embarrassed to buy condoms at the drugstore.

“They are very appreciative they can come in and receive condoms,” he said. “I want to see them protected from pregnancy and from sexually transmitted diseases. I tell them I am glad they are being responsible.”

Chlamydia is a sexually transmitted disease nine percent, or about 200 youth per year, have been treated for in the DCYHC, Gillette said. The DCYHC sees youth up to age 22.

Melissa Ambrose, special services counselor at Oceana High School, said she was in favor of having condoms available in her office.

“Transportation to the DCYHC is an issue for a lot of students,” she said.

Adrianna Hall, the mother of a son at Thornton, urged the board to make condoms available to students.

“Many of the students can’t afford to buy the condoms,” she said. “Condoms will go a long way to preventing pregnancy.”

“We want kids to stay healthy. This is one option that works,” said Gillette.

Other school districts in the Bay Area — San Francisco, some of the Oakland schools, Sequoia Union High School District — have policies allowing distribution of condoms in the high schools. In Half Moon Bay, the public health nurse can meet the student at a convenient location to distribute condoms.

JUHSD Board President Tom Nuris, whose sons attend Terra Nova, initially took the position of a reluctant parent and asked the board to weigh the pros and cons.

“We have to make a decision that’s right for the community. How do we deal with the backlash?” he asked. “There are people out there who don’t agree with this.”

In 2009, the pilot condom distribution program at Thornton made national news. Gillette recalled the superintendent then, Mike Crilly, did not receive any negative comments from the local community. He did, however, receive a couple negative comments from people out of state.

No one spoke against the idea at the JUHSD meeting last Tuesday. All the board members and the parents, teachers and counselors who spoke at the meeting said making condoms available to students will benefit them.

“You have convinced me,” said Nuris.

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Counseling Helps HIV Patients Stick to Treatment

By John Gever, Senior Editor, MedPage Today

Published: January 29, 2013

HIV patients receiving a year-long counseling program on problem solving showed better adherence to drug therapy in a randomized study, researchers said.

In the 180-patient trial, those assigned to the program, called Managed Problem Solving, were significantly more likely (odds ratio 1.78, 95% CI 1.07 to 2.96) to be classified in a higher adherence category compared with participants who received usual care, according to Robert Gross, MD, of the University of Pennsylvania in Philadelphia, and colleagues.

There was also a strong trend toward a greater likelihood of having undetectable viral loads in patients receiving the program (OR 1.48, 95% CI 0.94 to 2.31), the researchers reported online in JAMA Internal Medicine.

Gross and colleagues noted that the program was resource-intensive — involving 16 one-on-one counseling sessions followed by monthly telephone calls — but because the estimated cost per participant was “substantially less than $1,000 per year,” the increase in treatment adherence made it almost cost-effective, they argued.

As in other chronic illnesses, taking the prescribed medications regularly on schedule proves difficult for many HIV patients, Gross’ group wrote. Among the common barriers in this population are poor health literacy and social support, substance abuse, depression, and the complexity of their daily medication regimen.

Because these barriers vary from patient to patient, “personalized strategies … hold the greatest promise for success,” the researchers asserted.

The Managed Problem Solving program was designed to provide intensive assistance to patients in identifying and overcoming barriers to treatment adherence. It was delivered by staff members with no special training in psychology or counseling; they were required only to have a college degree and some experience with healthcare patients.

Patients in the study met with the counselor initially for 60 to 90 minutes, with three more in-person sessions held monthly and lasting up to 45 minutes. In between these sessions, the counselor sought to talk with the patient weekly by telephone, and then monthly for another 9 months.

During the early sessions, the counselor and patient “brainstormed” methods for overcoming barriers and discussed ways to implement them. Later on, the discussions turned to reviewing whether the chosen methods had helped as well as new problems that may have come up.

Counselors also reminded patients during the follow-up phone calls about refilling prescriptions.

The control group received usual care, which consisted of a single meeting with a pharmacist about their drug regimen and, if patients wanted, a pill organizer.

Patients had a mean age of 42, with about 60% male and 85% black. One-third had incomes below $5,000. Drug and “hazardous” alcohol use were present in 26% and 18%, respectively. Some 40% were treatment-naive when entering the study.

Adherence was measured with electronic monitors attached to the medication bottles, which could detect when the containers were opened. If a patient opened a bottle, it was assumed that he or she took the medication.

The authors set categories of adherence, ranging from greater than 95% to 70% or less.

The OR of 1.78 for patients receiving the intervention being in a higher adherence category applied at every follow-up point during the year-long study, they indicated. That figure was calculated on an intent-to-treat basis.

Dropouts were common, however. A total of 56 of the 180 enrollees left the study prematurely, including 33 assigned to the problem-solving program. Nearly half the dropouts disappeared without explanation.

When the authors examined outcomes among participants who completed the study, the OR for being in a higher adherence category at any follow-up point was 2.33 (95% CI 1.35 to 4.05) for the program. The researchers found no evidence that the effect changed over time, and it did not appear to depend on factors such as age, sex, race, or baseline viral load or CD4-positive cell count.

The per-protocol analysis also showed that the odds of having undetectable virus at any follow-up point was significant for patients receiving the intervention (OR 1.98, 95% CI 1.15 to 3.41).

There was a close relationship between adherence and virologic response: for each 25% increment in the proportion of prescribed doses actually taken, the OR for undetectable viral load was 1.99 (95% CI 1.64 to 2.41) in a conservative analysis (imputing a value of “detectable virus” for patients with missing data on viral load).

Gross’ group did not perform a detailed cost-benefit analysis. But they noted that previous studies had indicated that, in the HIV population, an intervention leading to a 10% improvement in adherence is cost-effective if it costs less than $1,000 per year per patient.

With each counselor earning $50,000 per year and following 20 study participants at 15% of total effort — and including the $150 annual cost for the pill-bottle monitors — the cost easily met that standard, the researchers indicated.

The study had some limitations: Participants could not be blinded to the study arm and were recruited from academic specialty HIV clinics where services for adherence may be greater than those in general medical clinics.

In an accompanying commentary, physicians at Massachusetts General Hospital in Boston said the study represented “significant progress toward a model of effective long-term adherence support.”

But drug therapy for HIV is lifelong, and “calling every HIV-infected person on treatment every month of their life may not be feasible or necessary,” wrote David Bangsberg, MD, and Jessica Haberer, MD.

Instead, they suggested that a more practical approach may be lifelong adherence monitoring — using pill-bottle monitors or other technologies — with interventions such as the current one reserved for patients with lapses in adherence.

“Advances in just-in-time adherence monitoring and support delivered when and where it is needed may transform treatment from success measured over years to success measured over a lifetime,” Bangsberg and Haberer wrote.

The study was funded by the NIH and the Philadelphia VA Medical Center.

Gross reported relationships with Bristol-Myers Squibb and Abbott. One co-author reported relationships with “numerous pharmaceutical companies” but none related to HIV or the current study.

Bangsberg and Haberer declared they had no relevant financial interests.

 

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Arizona bill seeks felony charge for intentionally exposing others to HIV, STDs

by Cronkite News

PHOENIX– A House Democrat wants to make it a felony to intentionally expose others to sexually transmitted diseases such as gonorrhea, chlamydia or syphilis.

“If you know you’re infectious, you should not be spreading that around no matter what the motivation is,” said Rep. Lela Alston, D-Phoenix.

Alston said she authored HB 2218 after hearing about a woman in her district who contracted an STD from a man who failed to tell her that he was infected.

The bill would make it a Class 6 felony for a person who knows he or she is infected with HIV or one of eight listed STDs to intentionally expose others.

As defined by the bill, exposure would include sexual intercourse or sodomy, selling or donating one’s own tissue, organs or bodily fluids, and sharing hypodermic needles or syringes.

The bill was referred to the House Judiciary Committee but had yet to be scheduled for a hearing as of Thursday.

Alston said what her constituent experienced constitutes criminal intent.

“This guy didn’t tell her he was infected so that she could protect herself,” she said.

Rep. Sally Ann Gonzales, D-Tucson, who signed on as a primary sponsor, said it’s important for the bill to address a range of situations.

“If we’re doing it for something, we might as well cover other things that are not yet protected or that we’re not holding people accountable (for) when they’re passing on these diseases in other ways other than sexual intimacy,” she said.

Anthony Paik, an associate professor of sociology and gender, women’s and sexuality studies at the University of Iowa, said that it’s difficult to tell how common it is for people to intentionally expose others to HIV or STDs.

“I don’t know of any research that actually looks at that question,” he said. “I’ve heard sort of anecdotal accounts on fairly rare occasions.”

Adina Nack, a senior research fellow for the Council on Contemporary Families, said the bill could be “potentially quite dangerous” owing to what she interprets as an emphasis on knowledge of being infected.

“Legislation like this could unintentionally discourage people from getting tested and treated and diagnosed,” she said.

Veda Collmer, the Robert Wood Johnson Foundation Visiting Attorney at Arizona State University’s Sandra Day O’Connor College of Law, said there was a trend in the late 1980s and early ’90s to criminalize this kind of behavior. Laws that were passed have nearly all been repealed, she said.

“They’re very difficult to prosecute,” said Collmer, who is with the college’s Public Health Law and Policy Program. “It would be hard to meet the burden of proof.”

Alston said she is cautiously optimistic about the prospects for her bill.

“I would hope that reasonable people would think that this is an important issue,” she said. “It’s a public health issue and very devastating to the individuals who are involved.”

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Possible ‘Achilles Heel’ of Key HIV Replication Protein

PITTSBURGH, Jan. 24, 2013 – Researchers at the University of Pittsburgh School of Medicine may have found an “Achilles heel” in a key HIV protein. In findings published online today in Chemistry and Biology, they showed that targeting this vulnerable spot could stop the virus from replicating, potentially thwarting HIV infection from progressing to full-blown AIDS.
Previous research demonstrated that a small HIV protein called Nef interacts with many other proteins in infected cells to help the virus multiply and hide from the immune system. The Pitt group developed a way to track Nef activity in high-throughput drug screening protocols by linking it to an enzyme called Hck, which is activated by Nef in HIV-infected cells, explained senior author Thomas E. Smithgall, Ph.D., William S. McEllroy Professor and Chair, Department of Microbiology and Molecular Genetics.
“We reasoned that agents that prevent Nef from its usual interactions with other proteins might be able to stop HIV from replicating and infecting other cells,” Dr. Smithgall said. “For this study, we devised an automated screening procedure and tested nearly 250,000 compounds to find ones that could block Nef activity.”
One of the compounds they discovered, called B9, seemed particularly potent at blocking Nef. In follow-up experiments, the research team examined how B9 accomplished this and found that it could prevent two Nef molecules from interacting to form dimers as effectively as a mutation in a critical area of the protein surface. The inability of Nef to dimerize consequently impairs its function in the viral replication process.
“This pocket where B9 binds to Nef and where Nef forms a dimer indicates it’s a hot spot, or Achilles heel, that could represent a new target for HIV drugs,” Dr. Smithgall said. “Our test tube and cell culture experiments show that blocking this site brings HIV replication to a halt.”
The team is working with medicinal chemists at the University of Pittsburgh Drug Discovery Institute (DDI) to find analogs of B9 that have therapeutic potential, and plan to assess them in animal models of HIV/AIDS.
Co-authors of the study include lead investigator Lori Emert-Sedlak, Ph.D., Purushottam Narute, Ph.D., Sherry Shu, Ph.D., and Jerrod A. Poe, Ph.D., all of the Department of Microbiology and Molecular Genetics, Pitt School of Medicine; Haibin Shi, Ph.D., Naveena Yanamala, Ph.D., John Jeff Alvarado, Ph.D., and Joanne Yeh, Ph.D., all of the Department of Structural Biology, Pitt School of Medicine; Paul Johnston, Ph.D., of DDI and the Department of Pharmaceutical Sciences, Pitt School of Pharmacy; and John Lazo, Ph.D., now of the University of Virginia.
The project was funded by National Institutes of Health grants R01 AI057083, R21 AI077444, and X01 MH083223.
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How to Survive a Plague

Journalist-turned-filmmaker David France unveils the courageous story of the activists and scientists who fought, sometimes with each other, to find a way to stop HIV from being a death sentence in “How to Survive a Plague,” a U.S. Documentary Competition film at Sundance 2012. Also an Academy Award Nominee for Best Documentary Feature.

Faced with their own mortality an improbable group of young people, many of them HIV-positive young men, broke the mold as radical warriors taking on Washington and the medical establishment.

HOW TO SURVIVE A PLAGUE is the story of two coalitions—ACT UP and TAG (Treatment Action Group)—whose activism and innovation turned AIDS from a death sentence into a manageable condition. Despite having no scientific training, these self-made activists infiltrated the pharmaceutical industry and helped identify promising new drugs, moving them from experimental trials to patients in record time. With unfettered access to a treasure trove of never-before-seen archival footage from the 1980s and ’90s, filmmaker David France puts the viewer smack in the middle of the controversial actions, the heated meetings, the heartbreaking failures, and the exultant breakthroughs of heroes in the making.

Official website

New York Times article

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Thinner Syringes May Reduce Risk of H.I.V.

By  

Published: January 21, 2013

 

A study suggests encouraging drug abusers to use thin syringes, which retain less fluid and the virus it may contain.

Distributing “low-dead-space syringes” to addicts could substantially lessen H.I.V.transmission among them, a new study has estimated.

Syringes have widely varying amounts of “dead space” — the amount of fluid retained even when the plunger is fully depressed, said William A. Zule, a researcher at RTI International and the lead author of the paper in The International Journal of Drug Policy.

Fat ones with interchangeable needles may have 40 times as much dead space as thin ones like those used by diabetics. And simulations of the way addicts draw in blood and rinse with water showed that the biggest syringes can retain 1,000 times as much virus as thinner ones.

Many foreign governments that distribute syringes ignore dead space and buy whatever is cheapest, Dr. Zule said.

Recipients of clean syringes are not supposed to share them, but some do. Users of heroin, cocaine or methamphetamine usually accept thin syringes, the study said. Users of poppy straw extract, homemade stimulants or crushed tablets may not.

The best way to get addicts to demand low-dead-space syringes, Dr. Zule suggested, may be to point out that they get more drug.

“That may not be politically correct, but you need messages that speak to the group you have to work with,” he said.

No human clinical trials have proved that such syringes save lives, but the idea is plausible and switching now would be affordable and safe, Dr. Zule argued.

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UNAIDS launches e-consultation to ensure AIDS remains central in the Post-2015 Agenda

23 January 2013

The international community is in the midst of negotiating the next global development agenda. This new roadmap is to be put in place after 2015, when the Millennium Development Goals will have reached their target date.

In order to capture a diverse a range of voices and views on how AIDS and health should be reflected Post-2015, UNAIDS is hosting an online and open-to-all consultation. This online conversation will run for two weeks, between 21 January and 3 February, and will be hosted on the official UN and Civil Society joint platform on Post-2015 negotiations, the World We Want.

The consultation invites views around three interrelated themes including: How the HIV epidemic remains relevant to the Post-2015 Agenda; how principles and practices forged in the AIDS response may contribute to a more equitable and sustainable health and development agenda; and how to reform systems of decision-making, monitoring, evaluation and accountability to guide efforts towards the end of the HIV epidemic.

The e-Consultation is being moderated by nine international experts on HIV, human rights, health and development. Together with the UNAIDS, moderators will produce a synthesis report at the end of the consultation. This report will be used widely to influence on-going negotiations, including the High-Level Health Thematic meeting (5-6 March, Botswana) and the UNAIDS-Lancet Post-2015 Commission.

The global HIV epidemic remains one of the world’s leading causes of death and is both a driver and consequence of inequality and social injustice. The AIDS response has always been a pioneer and a pathfinder on many fronts and can make critical contributions to doing health and development differently in the Post-2015 era.

To participate in the e-consultation please visit http://www.worldwewant2015.org/health

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Mount Sinai Summer Institute for NeuroAIDS Disparities: SCHOLAR GRANT REQUEST FOR APPLICATIONS

Mount Sinai Summer Institute for NeuroAIDS Disparities
MSINAD SCHOLAR GRANT REQUEST FOR APPLICATIONS

Background:
Racial and ethnic minorities (REM) constitute a disproportionate majority infected by HIV in the United States. There is need for capacity in medical science to study HIV-associated disorders in REM populations, to understand how disease manifests and whether pathogenetic mechanisms are influenced by qualities or conditions associated with race and ethnicity. Highly active anti-retroviral therapy (HAART) has not eradicated HIV-associated nervous system disorders. As life spans of people on HAART increase, the prevalence of HIV-related nervous system diseases is rising. The chronicity of these disorders, and their unique impact on functional ability, renders HIV neurobiology an important area of study. It is imperative that we understand the manifestations and pathogenesis of HIV-associated nervous system disorders in REM communities, as this is where the burden of disease is greatest in the 21st century.

Since psychiatric and cognitive disorders have as their primary output alterations in behaviors, socio-cultural modifications of behavior must be accounted for prior to defining disease entities and measures for their discovery. Once socially- and culturally-appropriate measures and definitions of HIV CNS disease are determined, do race and ethnicity modulate pathogenesis? As host responses to HIV (and more broadly, host immunologic reactivities) show genetically-determined variations, do race and ethnicity play a role in nervous system responses to HIV and neuroimmunologic perturbations? Do co-morbid conditions that segregate along racial and ethnic boundaries have a role in modulating CNS disease manifestations and/or progression?

The intention of this award is to support a junior faculty or pre- or post-doctoral fellow in becoming a successful contributor to the field of NeuroAIDS and health disparities research.  The grantee’s research proposal must be focused on either behavioral or pathogenetic aspects of HIV-associated nervous system disorders in minority populations. Recipients of the award will be expected to attend a 6 week summer institute at the Mount Sinai School of Medicine focusing on didactic and practical training in neuroAIDS research. Upon graduation from the institute, scholars will be awarded grants of up to $20,000 to continue pursuit of their research questions at their home institution.

Please download the flyer for more information:[Download not found]

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