Bristol-Myers Squibb and ADAP Crisis Task Force Announce Enhanced Support for AIDS Drug Assistance Programs New York City Latinos Benefit from Mt. Sinai Clinic
Tibotec’s Prezista Approved in South Africa
Boceprevir Shows Promise for Hepatitis C Treatment
German Pop Star Charged for Infecting Partner with HIV
Bristol-Myers Squibb and ADAP Crisis Task Force Announce Enhanced Support for AIDS Drug Assistance Programs
On August 14, Bristol-Myers Squibb Company (BMS) and the ADAP Crisis Task Force (ACTF) announced an enhanced agreement to support the efforts of AIDS Drug Assistance Programs (ADAPs) to provide antiretroviral medicines to people living with HIV and AIDS. According to the joint press release, “Building on an agreement signed in March of 2010, today's announcement marks a multi-year enhancement to assist ADAPs in meeting the challenges of increasing patient case loads and strained government funding.”
BMS has worked with the ACTF since 2002 to help ensure access to its HIV medications Reyataz (atazanavir) and Sustiva (efavirenz).
“Ensuring access to treatment for HIV and AIDS requires the commitment and participation of government, industry and the community,” said Lynda Dee of AIDS Action Baltimore and member of the Fair Pricing Coalition. “The Fair Pricing Coalition is pleased that Bristol-Myers Squibb continues to be a committed partner in meeting the needs of the HIV community.”Dwayne Haught, spokesperson for the ACTF, said, “We commend Bristol-Myers Squibb for responding to the unprecedented need faced by state ADAPs to provide access to HIV medicines and enhance our March agreement by providing additional support. Our long working relationship with Bristol-Myers Squibb made this agreement possible.”
"We are proud to support the ADAP Crisis Task Force and applaud their ongoing efforts in working with state and federal officials to secure the funding needed to appropriately meet this challenging public health need," said Raymond Sacchetti, senior vice president, U.S. Virology, Bristol-Myers Squibb.
BMS also offers people living with HIV/AIDS multiple ways to obtain medicine at reduced or no cost to the patient through the Bristol-Myers Squibb “Access Virology” program. Working directly with patients in need of assistance, the program evaluates a person's eligibility for multiple prescription assistance programs that are offered, including:
- Patient Assistance Program (PAP), which provides free BMS HIV medicines to eligible patients based on medical and financial needs; “fast tracking” of patients currently on an ADAP waiting list through accelerated advancement of their applications; a streamlined application process and eligibility criteria to help patients applying for medicine access.
- Reyataz and Sustiva Co-pay Benefit Program designed for eligible patients with commercial insurance coverage. Bristol-Myers Squibb will cover the first $200/month ($2,400/year) of an eligible patient's out-of-pocket co-pay costs for up to one year.
BMS also participates in the Partnership for Prescription Assistance and Together Rx Access. The Partnership for Prescription Assistance is an innovative program that helps connect patients with no prescription drug coverage to both public and private patient assistance programs. Together Rx Access offers eligible patients discounts for prescription medicines.
Additionally, BMS and Gilead Sciences have recently enhanced the Atripla Co-Pay Assistance Program to cover up to the first $200 per month (or $2,400 per year) of related out-of-pocket expenses for commercially insured patients that have been prescribed Atripla.
For more information on all the drug companies’ patient assistance card programs go to http://positivelyaware.com/2010/10_02/pick_a_card_pick_a_plan.shtml
New York City Latinos Benefit from Mt. Sinai Clinic
In July, the Mount Sinai Comprehensive Health Program (MSCHP) added the St. Vincent's HIV clinic in Greenwich Village to the successful HIV program already in place at Mount Sinai's Upper East Side campus. According to their press release, “the underserved Latino HIV/AIDS population in the greater New York area is now under the auspices of one of the preeminent, multi-disciplinary hospitals in the nation and a pioneering institution in HIV/AIDS care and research since 1989.” The takeover resulted in the seamless transition of 2,700 patients, a majority of which were Latino, and made the MSCHP one of the largest HIV programs in the country, with an anticipated 36,000 patient visits annually.
“Treating the Latino HIV/AIDS community presents unique challenges, and this transition was especially concerning for them,” said Dr. Lugo, an Infectious Disease specialist at the new Mount Sinai HIV clinic. “Knowing that they are now benefiting from Mount Sinai's world-class physicians and unparalleled research capabilities, we've been able to quickly calm fears and provide the sense of continuity that was desperately needed.”
The clinic provides primary care and infectious disease physicians, psychologists, psychiatrists, and specialists in dermatology, gynecology, and adolescent care. There are also subspecialty programs for HIV patients in neurology, renal care, hepatitis C co-infection and cancer screening, the release noted.
“I've been a patient at the clinic for 13 years and I can honestly say that we are a familia,” said Ernie Alvarez, an HIV/AIDS patient and leader of the Mount Sinai Consumer Advisory Board, a patient advocacy group. He went on to say, “Through the transition, Mount Sinai embraced us and now, we're an even a bigger, stronger ‘family’ that is optimistic for the future.”
“The Latino population in the U.S. has always been disproportionately affected by HIV/AIDS and today, approximately 20% of all new cases come from within that community,” said Guillermo Chacon, President of the Latino Commission on AIDS. “HIV/AIDS is not only a physical disease but also, it is a mentally and emotionally challenging one and Mount Sinai is one of the best things that can happen for this community. We look forward to partnering with them to keep HIV/AIDS prevention and treatment at the forefront of the national dialogue,” he added.
The Mount Sinai clinic is currently located in the same building as the former St. Vincent's clinic, the O'Toole Building, and offers assistance in Spanish, Mandarin, and Cantonese. A staff of social workers offers case management, substance abuse, and other social work services.
Tibotec’s Prezista Approved in South Africa
On July 23, the Tibotec Global Access Program and Aspen Pharmacare announced that the HIV drug Prezista (darunavir) 300 mg was approved by the Medicines Control Council (MCC) for use in antiretroviral treatment-experienced adult patients in South Africa.
A spokesperson from Tibotec said, “While access to first-line ARV regimens remains a top public-health priority in South Africa, a small but growing number of patients are in need of third- and even fourth-line therapies. The Prezista 300 mg approval brings us one step closer to fulfilling this need and to achieving Tibotec's commitment to access to innovative HIV/AIDS therapies in sub-Saharan Africa.”
Recent updates to both the South African and World Health Organization (WHO) HIV treatment guidelines are helping to develop a broader public-health approach for third-line therapy. Prezista and Intelence (etravirine) are both recommended in the updated WHO HIV treatment guidelines for use with highly treatment-experienced patients.
Boceprevir Shows Promise for Hepatitis C Treatment
According to an August 9 story in the online ScienceDaily, Paul Kwo, MD and his research team at Indiana University School of Medicine have completed a Phase 2 trial that showed that adding boceprevir, a hepatitis C virus (HCV) protease inhibitor, to the standard peginterferon alfa-2b plus ribavirin treatment nearly doubled the treatment's effectiveness when given for 48 weeks in one treatment arm of the study. The results were published in the current online edition of The Lancet.
The addition of boceprevir increased the cure rate to as high as 75% in those who received 48 weeks of the three-drug combination therapy, compared to 38% of those in the control group, who received the standard two-drug treatment for 48 weeks, said Dr. Kwo. The two-year Phase 2 trial was conducted at 67 sites with 520 patients in the U.S., Canada, and Europe.
Currently fewer than half of patients with genotype 1 hepatitis C (the most common and most hard to treat) are treated effectively by the standard combination, which is typically given for 48 weeks. The treatment can be difficult for some patients due to anemia and other side effects.
Boceprevir, a product of Merck & Co., is designed to block a key function to viral reproduction in the cell. Boceprevir directly targets the hepatitis C virus, Kwo noted, while peginterferon and ribavirin are less specific, acting more generally to stimulate the body's virus-fighting immune system.
In the boceprevir study, known as the SPRINT-1 trial, researchers tested several different options to evaluate the effectiveness of the combination therapy: the possibility that treatment could be shortened by the addition of boceprevir; seeing if a 4-week lead-in of the standard drugs prior to adding boceprevir would lead to improved sustained virologic response rates and lessen the virus’ resistance to boceprevir; and testing with a lower dose of ribavirin to reduce anemia side effects while keeping the virus from replicating.
“Both 28- and 48-week boceprevir regimens significantly increased sustained virologic response rates—which is the best definition of a cure we have—compared to the 48 week control,” said Dr. Kwo. "The 48-week treatment arm with 4 weeks of peg interferon lead-in and 44 weeks of peg interferon, ribavirin, and boceprevir led to the largest improvement over the control group ever reported. That's very impressive.
“Based on this Phase 2 study, it appears that if this drug receives final approval approximately two-thirds of patients will be able to be treated successfully with 28 weeks of treatment and one-third will need 48 weeks of treatment, though this will require confirmation from the Phase 3 trials, from which preliminary results were recently released,” said Dr. Kwo.
German Pop Star Charged for Infecting Partner with HIV
According to an AP wire report, Nadja Benaissa, 28-year-old member of the German girl band No Angels, has been charged with grievous bodily harm for allegedly infecting a partner with HIV in 2004. She also faces charges of attempted bodily harm for having unprotected sex with two other men. Prosecutors say Benaissa has known she is HIV-positive since 1999.
“I am sorry from my heart,” she said in a statement read by her lawyer to the Darmstadt administrative court. “No way did I want my partner to be infected.”
The man who claims Benaissa infected him says they had a three-month relationship at the beginning of 2004, and that he got tested after Benaissa's aunt asked him in 2007 whether he was aware that the singer was HIV-positive.
Benaissa was arrested in April 2009 and kept in custody for 10 days—a move that a German AIDS awareness group criticized as disproportionate. The Deutsche AIDS-Hilfe group argued that the question of whether her partners also carried a share of the responsibility had been neglected.
Since Congress is not in session, there’s no action to report. Both chambers will re-convene in mid-September.