HIV Innovations have yet to Arrive
By Mia Burns (firstname.lastname@example.org)
An unmet need for HIV still exists despite the success of antiretroviral therapies, and many obstacles stand in the way of non- antiretroviral therapies interventions, according to a report from research and consulting firm GlobalData. The report states that a continuous need exists for interventions to control the HIV pandemic, including prophylactic vaccines, salvage therapies, and an eventual cure for the condition, which will release patients from long-term antiretroviral therapies.
Different efforts targeting different aspects of HIV are emerging, according to GlobalData. These include latency reversal agents and immunotherapies that educate the immune system to eliminate virus-infected cells. GlobalData says that the success of a functional cure could well come from an intervention which combines these approaches.
Also, continuous improvements to antiretroviral therapies will also have a strong impact on HIV R&D approaches towards a cure, as new regimens, such as integrase inhibitors, boast a much better safety profile.
“There are patients that are unresponsive to antiretroviral therapies and also fail salvage therapies,” says Dr. Charalampos Valmas, GlobalData’s analyst covering infectious disease. “In addition, people who, despite achieving low viral loads, do not see increases in their CD4 T-cell counts, known as immunological non-responders, are in need of novel interventions that will reconstitute their immune responses. Obviously the biggest unmet need is effective prophylaxis. Although Gilead’s Truvada was approved in 2012 for PrEP, we have our reservations about how scalable this will be to address and control the pandemic. What is really needed is an effective prophylactic vaccine, which has been elusive for 30 years. The vaccine should be easy to distribute, inexpensive and should not require frequent boosting in order to effectively curb the pandemic.”
Dr. Valmas says that big pharma does not consider HIV or other STD vaccines to be as lucrative compared to airborne diseases such as influenza because of the limited patient segments that an HIV vaccine would initially address. As a result, research is instead being conducted by biotech companies, as well as academic and government-funded institutes, which sadly may not possess the financial capabilities to proceed to Phase III trials. These factors could lead to partnerships with big pharma, he told Med Ad News Daily.
“Biotech companies rarely have the bandwidth to proceed with late stage development,” Dr. Valmas. “At the same time, big pharma, for the most antiretroviral therapies, has withdrawn from the search for novel curative or vaccine approaches. GlobalData believes that big pharma will regain interest, once the first positive results from the biotech sector begin to emerge. We have already seen examples, such as those of Argos Therapeutics collaborating with Merck, and Bionor Pharma with non-antiretroviral therapies. Both collaborations aim at developing a kick-and-kill approach to eliminate latently infected cells from HIV patients.”
The report description mentions a potential treatment paradigm shift and the challenges it might pose on the antiretrovirals market. “The antiretrovirals market is a mature market,” Dr. Valmas told Med Ad News Daily. “HIV can be well-controlled and most patients can lead a normal life. However, dependence on antiretroviral therapies comes with issues, such as long term side effects or reduced compliance that can lead to resistance emergence. New approaches, such as therapeutic vaccines or latency reversal agents, or their combination do have the potential to result in controlled viral loads and therefore affect the frequency of antiretroviral therapies use.”
Antiretroviral therapies are expected to threaten curative treatments. “Novel regimens, still early in the pipeline, such as latency reversal agents, therapeutic vaccines, or even genetic modification of T-cells will face certain barriers to entry even if they are successful at bringing about the desired effect,” Dr. Valmas. “Complicated procedures, such as plasmapheresis, that are required in some of these technologies cannot be overlooked, especially against the background of continuously improving antiretroviral therapies. Another contender is long-acting formulations of existing antiretroviral therapies. Janssen’s long-acting parenteral formulation of Edurant and GlaxoSmithKline’s ‘744 can sustain clinically relevant concentrations for periods exceeding a month. GlobalData’s primary research has indicated that patients are keen to be treated once a month, even via parenteral administration.”
Posted: October 2013