Dolutegravir Expanded Access Programme
1 April 2012. Related: Antiretrovirals.
An Expanded Access Programme (EAPs) for dolutegravir, an integrase inhibitor in Phase 3 studies has been announced by ViiV Healthcare. [1]
This will provided open-label access to adults living with HIV who have documented raltegravir or elvitegravir resistance, who have limited treatment options, and who require dolutegravir to construct a viable antiretroviral regimen for therapy. [2]
As with all EAPs, this is based on the understanding that the safety and efficacy of dolutegravir has not been fully established or thoroughly evaluated by regulatory agencies, but that results from phase 2b studies usggest this may be an important life-saving option for people unable to enroll in clinical studies.
The dolutegravir EAP is now open and accepting participants in the USA and Canada.
For Europe and the International region, it’s expected that the EAP will start to open in March/April 2012 as local regulatory and ethics approvals are obtained.
Further details are available online.
http://www.dolutegravir-eap.org
comment
The importance of understanding the important of using dolutegravir in combination with other active drugs was highlighted by US community treatment activists. [3]
As with earlier EAP access, the benefits from using a single active drug will be limited. This may still be a life-saving option for someone at serious clinical risk of progression, but people who are able to defer use until other active drugs are available, are likely to gain the most durable response.
References:
- Dolutegravir Expanded Access Program (DEAP).
http://www.dolutegravir-eap.com - Dolutegravir Expanded Access Study (DEAP). ClinicalTrials.gov.
http://clinicaltrials.gov/ct2/show/NCT01536873 - Press release. Activists caution HIV+ patients and their physicians about monotherapy in upcoming access program (9 February 2012).
http://www.acria.org/content/activists-advise-caution-about-access-program