Genetically Modified T-Cell Therapy Appears to Be Safe and Lasting

 

HIV patients treated with genetically modified T-cells  remain healthy up to 11 years after initial therapy, researchers from the  Perelman School of Medicine at the University   of Pennsylvania report in  the new issue of Science Translational Medicine.  The results provide a framework for the use of this type of gene therapy as a  powerful weapon in the treatment of HIV, cancer, and a wide variety of other  diseases.

“We have 43 patients and they are all healthy,” says  senior author Carl June, MD, a professor of Pathology and Laboratory Medicine  at Penn Medicine. “And out of those, 41 patients show long term  persistence of the modified T-cells in their bodies.”

Early gene therapy studies raised concern that gene transfer  to cells via retroviruses might lead to leukemia in a substantial proportion of  patients, due to mutations that may arise in genes when new DNA is inserted.  The new long-term data, however, alleviate that concern.

“If you have a safe way to modify cells in patients  with HIV, you can potentially develop curative approaches,” June says.  “Patients now have to take medicine for their whole lives to keep their  virus under control, but there are a number of gene therapy approaches that  might be curative.” A lifetime of anti-HIV drug therapy, by contrast, is  expensive and can be accompanied by significant side effects.

To demonstrate the long-term safety of genetically modified  T-cells, June and colleagues have followed HIV-positive patients who enrolled  in three trials between 1998 and 2002. Each patient received one or more  infusions of their own T-cells that had been genetically modified in the  laboratory using a retroviral vector. The vector encoded a chimeric antigen  receptor that recognizes the HIV envelope protein and directs the modified T-cell  to kill any HIV-infected cells it encounters.

The researchers carefully monitored patients for any serious  adverse events immediately after infusion, but none were seen. Additionally,  because of the earlier concerns about long-term side effects, the Food and Drug  Administration (FDA) also asked the team to follow the patients for up to 15  years to ensure that the modified T-cells were not causing blood cancers or  other effects. Therefore, each patient underwent an exam and provided blood  samples during each of the subsequent years.

Now, with more than 500 years of combined patient safety  data, June and colleagues are confident that the retroviral vector system is  safe for modifying T-cells. By contrast, June notes, the earlier, worrying side  effects were seen when viral vectors were used to modify blood stem cells. The  new results show that the target cell for gene modification plays an important  role in long-term safety for patients treated. “T-cells appear to be a  safe haven for gene modification,” June says.

The multi-year blood samples also show that the  modified T-cell population persists in the patients’ blood for more than a  decade. In fact, models suggest that more than half of the T-cells or their  progeny are still alive 16 years after infusion, which means one treatment  might be able to kill off HIV-infected cells for decades.

tpan

The “Quad” Gains FDA Advisory Committee Backing

In more Advisory Committee news, on May 11, Gilead Sciences’  experimental HIV pill known as the “Quad,” received the committee’s 13-1 vote in  favor of approving the drug.

The Quad, a combination of four drugs, would be the newest  single tablet regimen (STR) that would enable HIV-positive people to control  the virus by taking just one pill a day.

The medicine is designed to have fewer side effects than the  current STRs Atripla and Complera. The Quad contains elvitegravir (an  experimental integrase inhibitor), emtricitabine (brand name Emtriva),  tenofovir (brand name Viread), and the experimental boosting agent cobiscistat.

According to Gilead’s studies, patients taking these drugs  were less likely to have abnormal dreams, trouble sleeping, dizziness, or rash  compared to Atripla, also manufactured by Gilead.

An FDA review of studies funded by Gilead  found a higher number of kidney complications reported in people taking Quad  compared with other HIV treatments. Those side effects included four cases of kidney failure and one  case of a rare syndrome where substances aren’t absorbed into the blood stream  by the kidneys. Still, there were fewer patients who stopped taking the Quad  early because of side effects and the incidence of side effects was similar to  other drugs, the FDA said.

“Quad has a potential to fulfill an unmet medical need with  patients with HIV infection,” Andrew Cheng, Gilead’s  senior vice president for clinical research and development operations, told  the panel.

“A once-a-day pill, depending on people’s lifestyle, that  doesn’t have neuropsychiatric side effects could be very appealing,” said  Demetre Daskalakis, an assistant professor at New York University School of  Medicine’s infectious disease division. “I feel like people would pick the Quad  as a first-line treatment.”

The FDA is scheduled to decide by August 27 whether to  approve the Quad for U.S.  sale.

comment TPAN

PMBSGN Update Support Group Meeting @ MIRC 5/15

 Positive Mind & Body Support Group Network

&

Midway Immunology  Research Center (MIRC)

 

Cordially invites you to an

Evening Dinner

Amongst  Friends

Tuesday, May 15th, 2012

 

Topic: HIV and Hep C confection

 Presented by – Dr. Roberto Ortiz

 

ViiV Healthcare – Melanie E. Hopkins

Regional Clinical Specialist

6:00 – 6:30pm Dinner

6:3pm – 7:30pm Presentation

   7:45pm – 8:30pm – Conclusion    

 

 

Location

 

Midway Immunology & Research Center (MIRC)

356 East Midway Road

Fort Pierce, FL  34982

772-464-9746

For additional details regarding this meeting you may also contact:

Positive Mind & Body Support Group Network

“A Positive Life is a Sound Mind & Body”

 

 (772) 563-2503 – (772)453-1067

www.positivemindbody.wordpress.com  

Upcoming Support Group Meeting @ Project Response ( Update )

Positive Mind & Body Support Group Network

&

Project Response

     Cordially invites you:    

May 16th, 2012

                                         

                                             Sponsored By:

 

CommCare Pharmacy

 

&

 

              Speaker:                    HOPWA

                                            Mark Burneko

                                 

5:00pm – Dinner

5:30pm – 6:30pm Topic Presentation

6::45pm – 7:15pm Open Forum Discussion among Friends

 

                Location:           Project Response

3501 Orange Avenue 

Fort Pierce, FL  34982

772-464-0420

 

For more Information & reserve seats

Contact your case manager:

Or

 

Positive Mind & Body Support Group Network

“A Positive Life is a Sound Mind & Body”

(772) 563-2503 – (772) 453-1067

ACT UP 25th Anniversary Demonstration against PWLA Being “Kicked to the Curb”

 

AIDS activists demonstrated in front of City Hall on April  25 over how people with AIDS are “being kicked to the curb” by Mayor Bloomberg and Human  Resources Administration (HRA) Commissioner Robert Doar due to recent AIDS  housing policy changes.

The demonstration is a part of the 25th Anniversary march and rally to  commemorate AIDS Coalition To Unleash Power (ACT UP), which forced New York City (NYC) and the  nation to respond to the needs of people with AIDS in the 1980s and ‘90s.

“ACT UP formed 25 years ago to demand that New York City and the nation put resources  into helping people with AIDS access basic care and services,” said Charles  King, CEO for Housing Works. “Today, Housing Works is still fighting for the  same demands for people—the right to housing for people with HIV, the right to  treatment and care, and the right to prevention methods like access to syringes  and condoms.”

Housing Works has always emphasized that “housing is the key” to ending the  AIDS epidemic, which is now supported by plenty of research. Despite this fact, NYC’s  HIV/AIDS Services Administration (HASA) policies have made the reality of  affordable housing even more difficult for people with HIV.

“If Mayor Bloomberg and HRA Commissioner Robert Doar continue to cut services  for people with AIDS, you’re going to see more homeless people in the streets  of New York,  just like this demonstration today,” said Derrick Chandler, Housing Works New  York State Issues Organizer. “We need to make sure that the city reverses the  recent changes to HASA that make it harder for people with AIDS to get access  to affordable housing.”

In February 2011, NYC’s Human Resources Administration announced it  would pay only half the full brokers’ fee for HASA clients in search of housing. At the same time, they also decided to issue vouchers—not checks—to pay  security deposits to landlords who have tenants on public assistance. As a  result, many brokers and landlords no longer want to work with HASA  clients, leaving many with fewer rental options.

This past December, HRA Commissioner Robert Doar announced a new policy  that would allow HASA to refuse permanent  housing to people who did not pass a substance use screening and refused treatment  prescribed by the city. The policy would penalize HASA clients who wanted  assistance in rent arrears payments or with getting into permanent housing.

ACT UP and its allies will also be using the march to pump up the volume on a  growing nationwide outcry for a “Financial Speculation Tax” (Fi.S.T.). This policy  would involve a small tax—a mere fraction of one percent—on speculative trading  by Wall Street investment banks, hedge funds, and other large financial  institutions. Activists say funds from the tax could be invested in providing  full access to treatment and services for people with HIV around the globe

TPAN

ADAP Advocacy Association Releases ADAP Solutions Summit Final Report

The ADAP Advocacy  Association (aaa+) announced on April 24 that it has released the final report  from its ADAP Solutions Summit, which was held in partnership with the Community  Access National Network (CANN) in Washington,   D.C. on April 2nd and  3rd. The purpose of this report is to convey some of the  programmatic changes, improvements, and reforms that could enhance the AIDS  Drug Assistance Program (ADAP) to better serve the needs of the people who  depend on it for access to their HIV medications. There were 3,079 people  living with HIV/AIDS on ADAP waiting lists in 10 states, as of April 19,  including 957 people in Georgia  and 910 people in Virginia.

“The Final Report represents yet another important step toward bringing this  nearly four-year crisis to an end,” summarized Brandon M. Macsata, CEO of the  ADAP Advocacy Association. “It doesn’t end the conversation, but rather  continues it by putting on the table some concrete solutions designed to  improve the AIDS Drug Assistance Programs. The report includes both short-term  and long-term recommendations; we couldn’t have achieved this milestone without  the expertise of the people who graciously volunteered their time, and ideas.”

The ADAP Solutions Summit convened a day-and-a-half roundtable with 42  panelists representing various stakeholder groups, including consumers, State  AIDS Directors, advocacy organizations, pharmacies, pharmacy benefit managers  (PBMs), pharmaceutical companies, social workers, physicians, allied-health  professionals, federal and state agencies and policy experts. Sixteen states  were represented, including seven states with current or previous ADAP waiting  lists.

The final report is not necessarily reflective of the views or opinions of  every panelist who participated on the roundtable, but it is a collection of  ideas and recommendations that came from the contributions of the panelists.

You can learn more about the summit online here,  or click here to download the report.

 tpan