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Let’s clinical! get Clinical trials: beyond virology by Suzanne MacCarthy Immune-based therapies are on the cutting edge of HIV clinical research and are advancing treatment strategies to a new level. Unlike current treatments that try to kill or suppress the virus while breaking down the immune system, immunology therapies are designed to boost the immune response to combat the virus on its own. Drs. Jean-Pierre Routy and Bertrand Lebouché from the Royal Victoria Hospital in Montreal, joined by José Sousa, community representative and CIHR Canadian HIV Trials Network (CTN) Community Advisory Committee chair, led an open dialogue at the 6th Canadian HIV/AIDS Skills Building Symposium in Montreal from March 4 – 7, to discuss this new direction in HIV research. PWAs and community representatives heard about developments in immune-based trials and the corresponding ethical issues in informed consent. Facilitated by the CTN, this gathering of science and community was the first of its kind in Canada. Dr. Routy’s research in immune-based therapies aspires to give PWAs a break from the complications and costly toll of highly active antiretroviral therapy (HAART). Dr. Routy acknowledges the lifesaving benefits of HAART but also believes that 14 years after its advent, we need to investigate alternative therapies. Advancing research in immune-based therapies wouldn’t be possible without the commitment and support of community members, says Sousa. For immune-based trials, there are certain ethical issues surrounding informed consent that must be considered. “Participation in immunology trials generally excludes individuals from joining any other clinical trials,” said CTN/Merck Studies enrolling in BC CTN 247— CTN 244— CTN 240— Canadian cohort of HIV-positive slow progressors BC sites: St. Paul’s Hospital, Vancouver; Spectrum Health Care, Vancouver; Downtown Infectious Diseases Clinic (DIDC), Vancouver; Cool Aid Community Health Centre, Victoria Seek and Treat for Optimal outcomes and prevention in HIV & AIDS in IDU (STOP HIV & AIDS in IDU) BC sites: St. Paul’s Hospital, Vancouver Valacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial BC site: DIDC, Vancouver CTN 238— CTN 236— CTN 194— 32 living5 MayqJune 2010 postdoctoral fellow Dr. Bertrand Lebouché. “Immune-based therapies may have persistent effects on an individual’s immune system and would therefore impact how he/she responds to other treatment studies.” In order to successfully recruit participants, researchers must find ethically justifiable ways to help ensure individuals remain eligible for other clinical trials after participating in an immune-based study. CTN 239, which investigated AGS-004, an immunotherapeutic agent composed of an individual’s white blood cells and a sample of their pre-HAART HIV, did succeed in recruiting participants who had been involved in immunebased trials no more than six months before the beginning of the study. Results from this study will be presented at AIDS 2010 in Vienna in July. At present, the CTN doesn’t have an immune-based study enrolling participants in BC. However, Dr. Routy is currently leading an immune-based cohort in Montreal to analyze the impact of HIV on memory CD4 T-cells during HIV disease progression and after initiating antiretrovirals. The study will be extended to BC; researchers hope to begin enrolment this summer. 5 Suzanne MacCarthy is the communications and information coordinator at the CIHR Canadian HIV Trials Network in Vancouver. The MAINTAIN study BC sites: DIDC, Vancouver St. Paul’s Hospital, Vancouver HPV vaccine in HIV-positive girls and women BC site: Oak Tree Clinic, Vancouver Peg-Interferon and citalopram in co-infection (PICCO) BC sites: St. Paul’s Hospital, Vancouver; DIDC, Vancouver To find out more about these and other CTN studies, visit the CIHR Canadian HIV Trials Network database at www.hivnet.ubc.ca or call 1.800.661.4664.
what’s new in research Report from CROI 2010 By Dr. Marianne Harris The 17th Conference on Retrovirus and Opportunistic Infections was held in February 2010 in San Francisco. Researchers from the BC Centre for Excellence in HIV/AIDS presented two important studies. Dr. Mark Hull and colleagues performed an analysis of the Canadian Observational Cohort Collaboration (CANOC) cohort, a cross-Canada collaboration. They analyzed 1,674 HIVpositive adults who received highly active antiretroviral therapy (HAART) between January 2000 and December 2008. Study participants had all achieved two viral loads below 400 copies/mL in a row, and had six or more viral load results available over the following two years. Participants were classified into four groups: full suppressors— all viral loads during follow-up were below 50 copies/mL; transient viremia (detectable virus in the blood)—viral loads below 50 copies/mL for at least 75 percent of the time, and the remaining viral loads were between 50 and 1000 copies/mL; short-term persisting viremia—viral loads below 50 copies/mL 25 to 75 percent of the time; and long-term persisting viremia—viral loads below 50 copies/mL less than 25 percent of the time. Viral rebound was defined as having two viral loads in a row—from two different tests—above 1,000 copies/mL—this is usually accepted as a sign of treatment failure and indicates the need to change antiretroviral therapy. The risk of viral rebound was about the same for people with transient viremia as for the full suppressors, suggesting that occasional low-level viral load “blips” don’t predict ultimate treatment failure. On the other hand, people with short-term persisting viremia were about six times as likely to experience viral rebound as full suppressors. Long-term persisting viremia was even worse—people with longterm persisting viremia were about 20 times more likely to have viral rebound than the full suppressors. These results confirm that sustained suppression of the viral load to below 50 copies/mL, at least 75 percent of the time remains the ideal goal of successful HAART. The second presentation showed that PWAs with undetectable levels of HIV in their blood are less likely to transmit the virus to others. Dr. Julio Montaner presented data showing an association between the number of people receiving HAART in BC and the number of new HIV infections diagnosed in the province. HAART first became available in BC in 1996, and over the next three years the number of people in the province newly diagnosed with HIV decreased by nearly half—from about 700 in 1996 to about 400 in 1999. Over the next several years, the number of British Columbians receiving HAART remained stable at about 2,500. Then, between 2004 and 2009, there was roughly a doubling of the number of people receiving HAART to about 5,000. A significant drop in the number of new HIV diagnoses in BC again followed this expansion of HAART coverage, despite that fact that more people were being tested. Of note, starting in 2007 there was a targeted effort to encourage HAART use particularly among injection drug users (IDU) in Vancouver’s Downtown Eastside. Over the next two years, the number of new HIV infections in this population fell by about half. Dr. Montaner acknowledged that there may be many factors contributing to the decline in new HIV diagnoses in this population and in BC in general, and that a significant proportion (estimated to be about 20 – 25 percent) of people who are HIV-positive aren’t aware of their diagnosis. However, these BC data provide the first evidence of an association between the number of people receiving HAART and the rate of new HIV infections within a large population, even amongst the most vulnerable IDU group. Details on these and other conference presentations can be found at the CROI website at www.retroconference.org/2010. 5 Dr. Marianne Harris is a family doctor with the AIDS Research Program at St. Paul’s Hospital in Vancouver. MayqJune 2010 living5 33
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