Compassionate use

The Issue

ViiV Healthcare is an independent, global specialist HIV company established in 2009 with commitment to deliver innovative new options for the care and treatment of people living with HIV/AIDS.

An essential element of our work is to develop our medicines through conducting clinical trials, where we work with Healthcare Professionals (HCPs), patients and healthy volunteers to evaluate an investigational medicine’s efficacy and safety prior to securing regulatory approval.

Regulators will only authorize a new medicine if these trials, together with other research data, demonstrate a medicine has a favorable risk benefit profile. And a medicine can only be marketed and made available to patients after it has been authorized. We therefore ensure our resources are applied to the efficient conduct of these trials, in order to bring our medicines as quickly as possible to those who need them.

There will however be occasions when it may be in the interest of people living with HIV or those at high risk of acquiring HIV, to have access to our investigational medicines where enrolment into a clinical trial is not an option. Under these circumstances, and where people living with or at risk for HIV have no satisfactory alternative treatment or prevention options, regulators may grant permission for companies to provide a treating HCP with an investigational medicine. Such use of an investigational medicine outside a clinical trial is often called “compassionate use” or “expanded access” (but may go by other names).

This information provides ViiV Healthcare’s approach to the compassionate use of our investigational pharmaceutical products (referred to as investigational medicines) and the criteria we use to assess requests from HCPs.

ViiV’s Position

• ViiV Healthcare recognizes that there may be circumstances when HCPs deem it appropriate to give their patients investigational medicines where no satisfactory alternatives exist.
• ViiV Healthcare considers the need for compassionate use for all our investigational medicines early in the planning of our research programs. Recommendations based on these needs/ considerations are approved by our Chief Medical Officer.
• We support compassionate use for patient populations meeting specific criteria managed under formal programs, as well as for named (or individual) patients where appropriate and subject to fulfillment of our criteria.
• All requests for compassionate use of a ViiV Healthcare investigational medicine, which must be made by an HCP, will be considered by ViiV and we will work with the requestor to support them through the request process.
• All HCP requests for compassionate use of a ViiV Healthcare investigational medicine are considered against the following threshold criteria (additional specific criteria defined per program):
  • The patient either has HIV or is at high risk of acquiring HIV.
  • There are no comparable or satisfactory alternative treatments or prevention options (confirmed by the HCP).
  • Patient enrollment in a clinical trial is not possible.
  • There is sufficient evidence to believe the benefit to the patient justifies the risk.
  • Providing the investigational medicine will not interfere with investigational trials that could support the investigational medicine’s development or marketing approval.
• Other key considerations include (but are not limited to):
  • Whether sufficient information to inform appropriate use of the ViiV investigational medicine exists.
  • That use will be in a country where appropriate medical oversight exists.
  • That the proposed compassionate use complies with local laws and regulations.
• These criteria help ensure we have a consistent approach for our decisions on compassionate use.
• Information about our compassionate use activities are set forth on various independent registers, including ClinicalTrials.gov and European Medicines Agency.

Background

Information about a medicine’s efficacy and safety may be limited at the stage at which an investigational medicine is requested and provided for compassionate use. Studies relating to the toxicity of an investigational medicine will generally have been completed and analyzed, and early studies looking at how the medicine is handled by the body will have been completed. However, there may still be uncertainty about the best way to give the medicine to patients, such as the exact dose to use, the dose frequency, and the medicine’s efficacy and safety profile (which side effects it can cause) which may not yet have been fully established. These uncertainties mean that very careful assessments must be undertaken before making investigational medicines available for compassionate use.

Patients interested in accessing a ViiV investigational medicine for compassionate use should talk to their doctors.

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