(Vancouver) – A pilot study to evaluate the impact of anti-retrovirals on HIV-transmission rates has garnered critical support among all key stakeholders, Dr. Julio Montaner announced today in his plenary address at the XVI International AIDS Conference.
The population-based study slated to take place in Vancouver, British Columbia, now has the essential backing to move ahead to the planning stage, says Montaner, Director of the B.C. Centre for Excellence in HIV/AIDS at St. Paul’s Hospital.
“We now have the necessary support and political will to expand ARVs in a controlled fashion within a very well characterized setting in B.C. where we can determine its impact on HIV incidence rates — the results of which will be critical to informing health policy worldwide,” says Montaner, who will be appointed President-elect of the International AIDS Society at the completion of the conference.
Gilead Sciences has stepped forward in support of the study concept and is currently involved in initial discussions.
“We believe that Dr. Montaner’s population-based study has significant scientific merit and would like to engage in further discussion to flesh out the proposed pilot study,” says Dr. James Rooney, Vice President, Medical Affairs, Gilead Sciences (Foster City, Calif.).
The Province of B.C is extremely interested in the prevention potential of expanding ARVs, also referred to as triple-drug therapy or, more formally, highly active antiretroviral therapy (HAART).
“HAART has led to tremendous success in B.C. in extending the lives of people living with HIV. We support the work of Dr. Montaner and his Centre colleagues to explore and develop this exciting new prevention concept. We look forward to receiving more information as the study protocols are developed and refined,” says Dr. Perry Kendall, B.C.’s Provincial Health Officer.
Vancouver Coastal Health, which provides health-care services in the region, welcomes the opportunity to partner with the Centre in moving this project forward, says Heather Hay, Director for Addiction, HIV/AIDS, Aboriginal Health Services, Vancouver Coastal Health.
“Vancouver Coastal supports the research direction Dr. Montaner is taking. Any approach that has the potential to benefit our clients is one we certainly favour. We look forward to working together with the Centre as we begin a plan to put a pilot project into operation,” says Hay.
The province’s HIV-positive association also backs Montaner’s plan.
“The B.C. Persons with AIDS Society is pleased to support Dr. Montaner’s recently announced research proposal to investigate the effects of HAART as one part of the many multi-faceted approaches to the management of HIV,” says Paul Lewand, Chair of the BCPWA.
On Aug. 5, The Lancet published an article highlighting that the use of HAART has been historically focused on improving patient outcomes, not transmission rates. The article, authored by Montaner and Centre researchers, states emerging evidence underlines transmission of the virus is rare by persons with undetectable viral loads of HIV in their blood, owing to use of HAART. A hypothetical model illustrates the expansion of HAART could significantly lower transmission rates and be cost-effective in the long-term.
“We must stress that we do not see HAART as a replacement for the prevention effort –including vaccine research — but rather as an essential part of it,” cautions Montaner.”The transmission of the virus could be dramatically reduced with the appropriate expansion of HAART for those who require treatment.”
While the majority of new cases continue to emerge from developing nations, HIV incidence levels remain unacceptably high in developed countries with comprehensive prevention programs. It’s believed 35 per cent of Vancouver’s estimated 15,000 injection drug users are currently HIV infected. As well, newly positive HIV tests reported among gay men in B.C. continue to surpass late 1990 levels. In B.C., a 2003 study determined one-third of those who died from HIV-related causes did not receive any life-saving treatment.
The availability of rapid HIV testing coupled with a new highly effective one-pill-a-day, fixed-dose, drug combination represents a unique opportunity to expand global HAART programs and potentially curb the global growth of the pandemic.
Important clinical and ethical protocols to be developed will include informed consent prior to initiating HIV testing or treatment for all study participants.