We are focused on finding new medicines to improve outcomes for people living with HIV and understanding how best to prevent and treat the disease.
At ViiV Healthcare our scientists are 100% dedicated to finding new ways to limit the impact of HIV on the 36 million people living with the virus.
Although there have been significant advances in HIV therapy in recent years, until we have a cure we must maintain investment into developing new medicines and remain vigilant over how the virus evolves resistance to treatment. We know that new medicines will always be needed that are at least as effective as current options and treat patients who have limited options due to the development of resistance. Additionally, new medicines will need to offer improvements in areas such as tolerability, safety, dosing schedules, drug interactions and convenience.
As well as the five investigational medicines we currently have in the clinic, our investment in R&D supports early work to identify new therapeutic options such as antiretroviral drug candidates with novel mechanisms of action and treatment of HIV-related immune dysfunction. We actively collaborate with other commercial and academic organisations to work towards a cure and also seek new business alliances to ensure we will deliver the innovative HIV treatments of the future.
Another avenue of research that we have prioritised is the investigation of innovative strategies and uses of existing antiretroviral agents. Examples include investigating our medicines in preventing HIV infection as Pre-Exposure Prophylaxis (PreP) and Treatment as Prevention (TasP). We have also begun a study of long-acting preparations (LAP) which could potentially reduce dosing frequency from daily pills to monthly or quarterly injections. The development of paediatric formulations is also a high priority for ViiV Healthcare such as our collaboration with CHAI & Mylan on a low-cost dispersible medicine for children living with HIV in developing countries.
We also recognise that in spite of many scientific advances there are still too many gaps in our understanding of how best to prevent and treat HIV in certain populations and areas of the world. That’s why we are currently supporting 36 collaborative research studies to address public health priority areas among 38,000 adults and children living with HIV in resource-limited settings.
Prioritising research into HIV in children
In order to expand the research evidence base in children, 24 of the 36 collaborative research trials we currently support in the developing world are investigating prevention of mother-to-child HIV transmission and paediatric treatment strategies. In addition our £10 million Paediatric Innovation Seed Fund supports diverse research initiatives in Asia, Africa and Eastern Europe to improve the diagnosis, treatment and care of infants and children living with HIV.
Our commitment to clinical trial transparency
ViiV Healthcare has a long-standing commitment to data transparency. Since the company was formed in 2009, we have been working to ensure we disclose research data and share information from our clinical trials.
We recognise that transparency in research is fundamental to accelerate scientific progress in developing innovative new treatments. To this end, we have set up a clinical study register to deliver on our commitment to share clinical trial information and data with the broader academic and research community working in HIV.
Protocol Summaries, Result Postings and Anonymized Clinical Data
When interventional studies involving human subjects are initiated, protocol summaries of ViiV Healthcare-sponsored studies are posted on our own clinical study register before the first subject is enrolled. Additionally, the ViiV Healthcare clinical study register provides an easily accessible repository of data from ViiV Healthcare-sponsored clinical studies and includes the following information:
- Protocol summaries for ongoing studies (a brief description of what is being researched and what the study is designed to discover)
- Results from completed clinical studies on compounds that are both investigational and approved medicines
- Results of observational research (studies of ViiV Healthcare medicines) and meta-analyses (which combine and analyse the results from two or more previous studies)
- Results from studies of terminated medicines - this informs the scientific community about research results for medicines that ViiV Healthcare is no longer progressing in development. This may reduce exposure of volunteers to similar compounds for clinical research.
- The names of principal investigators who participate in our clinical research
We submit the results of interventional human subject research studies as comprehensive manuscripts for publication in peer-reviewed journals that are indexed by online search engines within 18 months of study completion.
We also register ViiV Healthcare-sponsored clinical trials (phase I-IV) of investigational and marketed medicines on external registries as required by current regulation through http://www.clinicaltrials.gov/ and https://www.clinicaltrialsregister.eu.
Following completion of these clinical studies, result summaries are posted on the ViiV Healthcare clinical study register within eight months, irrespective of the outcome of the study.
We have also committed to sharing anonymised Individual Patient Data (IPD) and redacted Clinical Study Reports (CSRs) once the initial study data is published, via https://clinicalstudydatarequest.com/Study-Sponsors-ViiV-Details.aspx.
The clinical trial register is undergoing upgrades to enable further improvements to how we disclose clinical trial information and make it readily available to the public.
Beyond this, we continue to evaluate potential enhancements to improve access to our research results regarding ViiV Healthcare investigational and marketed medicines beyond our existing clinical trial registry to further facilitate transparency with the scientific community, prescribers, and patients. Updates will be made available in due course on our corporate website as and when we publish more information and update our policy.
For more information please contact:
Tel: +44 (0) 208 380 6200