Coburn Introduces the HIV/AIDS Save Lives First Act
Tibotec’s Rilpivirine Passes Phase 3 Trials
HIV-positive People with Hepatitis C More Likely to Develop Osteoporosis
Compassionate Pricing for Sitting Pain Shorts
Coburn Introduces the HIV/AIDS Save Lives First Act
On July 21, Senate Republican Tom Coburn of Oklahoma introduced Senate bill 3627 (S.3627), legislation that would ensure that United States global HIV/AIDS assistance prioritizes saving lives by focusing on access to treatment.
In his statement to the Senate, Coburn said, “This important piece of legislation will make crucial improvements in our approach to bilateral global AIDS efforts. As a practicing physician and former co-chair of President Bush's Advisory Council on HIV/AIDS, I have introduced this bill to ensure that our global AIDS efforts continue to prioritize life-saving medical treatment and reduce the transmission of the disease from mother to child.”
Senator Coburn noted that the President’s Emergency Plan for AIDS Relief (PEPFAR) has been successful in providing two and a half million HIV/AIDS patients from 30 different countries access to lifesaving treatment and that it has been estimated that “from 2004-2007 as many as 1.2 million lives had been saved because of the program.”
In 2008, Congress, in what has become an extremely rare case of bipartisanship, passed the United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act to continue the important life-saving work of the PEPFAR program. Said Coburn, “It is of grave concern, then, that our fight against AIDS is now at risk of failure. A recent New York Times article, ‘At Front Lines, AIDS War Is Falling Apart,’ details how hundreds of thousands of patients are being denied promised care in countries such as Uganda.”
Former UNAIDS chief Dr. Peter Piot remarked about past success and doubts about the future. “Then, we were at a tipping point in the right direction,'' he explained. “Now I'm afraid we're at a tipping point in the wrong direction.''
Coburn, also a co-sponsor of the Access ADAP Act (S.3401), went on to explain to his colleagues the facts about the costs of prevention and early treatment as opposed to the costs, financial and otherwise, of neither an aggressive testing policy nor a way to ensure access to treatment.
In his statement, Coburn said, “By emphasizing providing life-saving treatment under the PEPFAR program, we can continue the enormous success we have had in saving lives and preventing the spread of this terrible disease. It is my sincere hope that my colleagues adopt these common sense policy changes that will significantly reduce human suffering, keep families together, and save millions of lives.”
The bill now goes to the Committee on Foreign Relations.
Tibotec’s Rilpivirine Passes Phase 3 Trials
On July 22, at the 18th International AIDS Society conference in Vienna, Tibotec Therapeutics announced results from two pivotal Phase 3, double-blind, randomized clinical trials, ECHO and THRIVE, comparing the efficacy, safety, and tolerability of its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) TMC278 (rilpivirine) versus Sustiva (efavirenz), each administered once daily with a nucleoside/nucleotide background regimen in treatment-naïve, HIV-1-positive adults. These global trials reached their primary objective, which was to demonstrate non-inferiority of rilpivirine versus efavirenz in the proportion of patients achieving an undetectable viral load (less than 50 copies/mL) at week 48.
ECHO and THRIVE pooled results showed that 84.3 percent of patients in the rilpilvirine group reached an undetectable viral load, compared with 82.3 percent of patients in the efavirenz group. The difference between the treatment groups was not significant.
“I’m very excited by the findings of these Phase 3 results for TMC278,” said Cal Cohen, MD, MSc, lead clinical investigator and Research Director at Community Research Initiative of New England and Harvard Vanguard Medical Associates. “These studies provide valuable information on the safety and tolerability of TMC278 and, specifically, its metabolic and CNS [central nervous system] side effect profiles.”
ECHO and THRIVE are being conducted at more than 100 sites, in more than 20 countries. The studies will last for a total of 104 weeks, which includes a four-week screening period, a 96-week treatment period, and a four-week follow-up period.
Tibotec Therapeutics submitted its New Drug Application (NDA) for TMC278 to the FDA on July 26. Tibotec has also entered into a license and collaboration agreement with Gilead Sciences, Inc. for the development and commercialization of a once-daily, fixed dose combination of TMC278 and Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate).
HIV-positive People with Hepatitis C More Likely to Develop Osteoporosis
According to a U.S. study presented at the 18th International AIDS Conference in Vienna, HIV-positive people co-infected with hepatitis C virus (HCV) may be more likely to develop osteoporosis and sustain fractures than individuals with either virus alone. Roger Bedimo, from the Veterans Administration North Texas Healthcare System, looked at osteoporotic fractures or breaks in the wrist, vertebrae, or hip due to loss of bone mineral density.
Approximately one-third of HIV-positive people are co-infected with chronic hepatitis C, which is also linked to low bone mineral density and increased risk of fractures. Bedimo pointed out that while women are more likely to sustain fragility fractures, men are more likely to die from fracture-related complications.
Researchers retrospectively identified all patients in the Veterans Affairs' Clinical Case Registry who were diagnosed with HIV between 1988 and 2009 and subsequently sustained osteoporotic fractures. The analysis included 56,660 HIV-positive people, almost all men, and approximately one-third of whom were co-infected with hepatitis C. About two-thirds had taken antiretroviral therapy (ART) for an average duration of four years. Participants were followed for just over five years on average, for a total 305,237 person-years of observation.
The investigators compared fracture rates between people with HIV alone and those with HIV/HCV co-infection. They then looked at the influence of other factors linked to bone loss including age, race/ethnicity, body weight, ART use, diabetes, chronic kidney disease, and smoking. During the observation period, 951 people sustained at least one osteoporotic fracture. Most fractures (451) affected the wrist, followed by 308 broken hips and 106 vertebra fractures.
The researchers then calculated the impact of co-infection and the other confounding factors on fracture risk. While 51% of people who sustained fractures were HIV/HCV co-infected, this fell to 31% among fracture-free individuals. Both single-factor and multivariate analysis found co-existing HCV infection to be a significant independent predictor of osteoporotic fractures. In other words, co-infection was associated with a 27 to 43% increase in risk.
These findings led Bedimo and colleagues to conclude that HCV co-infection is a significant risk factor for osteoporotic fractures in HIV-positive people, and that fractures appear to be increasing among HIV/HCV co-infected people during the ART era.
Compassionate Pricing for Sitting Pain Shorts
Terry Delonas, cofounder of LipoWear, announced on July 23 that he has instituted a compassionate pricing policy for SitRelief Shorts, a pain-relieving, padded undergarment designed for certain patient populations that experience significant sitting pain. This includes people with HIV, cancer, and seniors, as well as others.
Delonas noted, "Many of our customers have had their income compromised by their health conditions and the current economy and we have decided to make our product more affordable while we are in the process of getting a Medicare code which will allow reimbursement. We will be reducing the price to 50% of the suggested retail price for as long as possible to help these customers."
The clinically tested padded shorts are highly effective and alleviate sitting pain, a debilitating problem caused by fat and muscle wasting in the buttocks resulting in crushed nerves when sitting which causes the withdrawal from many daily and social activities that contribute to a better quality of life.
SitRelief Shorts are available for both men and women at www.lipowear.com.