Funding challenges threaten HIV/Aids vaccines R&D

Mitchell warren

Mitchell warren

Roselyne Sachiti recently CHICAGO, US —
A New report has revealed how research and development for Aids vaccines, microbicides, pre-exposure prophylaxis using antiretroviral drugs (PrEP) and treatment as prevention (TasP) are in danger of being slowed or even sidelined because of inadequate funding. 

According to The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 12th annual report, HIV Prevention Research & Development Investments, 2000-2015 Investment priorities to fund innovation in a challenging global health landscape, released at the HIV Research for Prevention 2016 (HIVR4P) conference in Chicago, US, last week, funding for R&D of new and emerging prevention options decreased slightly in 2015.

This, according to the report was due in part to decreases from the US public sector and a downswing in global philanthropic funding.

“It is critical that investments into HIV prevention innovations, science and technology are scaled up to put us firmly on the Fast-Track to ending AIDS by 2030,” said Luiz Loures, Deputy Executive Director, UNAIDS.

In 2015, funders invested a total of $1,20 billion across R&D, down from $1,25 billion in 2014, across eight key areas: preventive AIDS vaccines, microbicides, PrEP using antiretroviral drugs, TasP, HSV-2 vaccines and operations research related to voluntary medical male circumcision, female condoms and prevention of vertical transmission.

The report also states that investment is being made along all phases of the research pipeline but remains concentrated among a few large investors. A more diverse base of funders would increase the stability of R&D financing and cushion the impact if any of the major funders were to reduce their investments.

To improve continuity, RTWG said there was need for a more balanced funding base, especially through support of new investment by European and low- and middle-income countries.

The US public sector (primarily via the National Institutes of Health) remained the largest global contributor at $850 million, accounting for 70 percent of total funding.

Together the US government and the Bill and Melinda Gates Foundation, the largest philanthropic funder, accounted for 81 percent of all funding in 2015.

“There is now very strong momentum in research and development, and we need to expedite the development of vaccine strategies and other new, biomedical prevention options that promise to be safe, accessible and effective for use throughout the world,” president and CEO of IAVI, Mark Feinberg said.

He said there should be adequate and sustained investment at all stages from early laboratory research and to clinical testing if the HIV pandemic is to be contained and end AIDS.

This comes at a time daily oral PrEP is gaining traction as a new prevention option in an increasing number of countries; an antiretroviral-based microbicide ring that showed modest efficacy earlier in 2016 will be further evaluated to determine its viability as a prevention option for women; large-scale efficacy trials of an AIDS vaccine candidate and an injectable form of PrEP are slated to begin soon and a novel proof-of-concept trial of antibody-mediated prevention is underway in several countries.

Many more promising candidates in earlier stages are progressing toward pre-clinical and clinical evaluation.

The year 2015 also saw increasing investment in the science of delivery – or implementation research – primarily focused on delivery of TasP interventions.

Such investments will become even more important to help ensure new prevention options move quickly and efficiently into prevention programs and begin to have an impact on HIV infection rates. Many African countries, Zimbabwe included, have been part of research for prevention for many years.

Sad is that because of various reasons, that include lack of funding and commitment by most African governments after the research findings, most countries have not fully benefited from study products particularly those found to be efficacious – Treatment as Prevention (TasP) and Pre Exposure Prophlaxis (PrEP).

It always seems easy for development partners to put money into research and development but “disappear” when the drugs become available.

It also seems that most African countries are slow to respond to the next step, that of self funding, after positive research findings.

In the absence of such investment countries like Zimbabwe end up being testing grounds of drugs they never get to use.

Already richer countries like the US, Australia and South Africa have rolled out PrEP programmes and Zimbabwe is still struggling with guidelines in the midst of low resources competing with treatment.

To adapt the HIV guidelines, the Ministry of Health formed a committee with five subgroups, including one on PrEP.

In the midst of all this, Zimbabwe has already moved on to new studies (AMP) and preparations are underway for one more biomedical study coming hard on the heels of previous studies.

In an interview with The Herald, AVAC executive director Mitchell Warren, said to avert fatigue in research communities, it is important to understand what comes after a positive result of a research.

“Research is a very challenging activity scientifically, but we all have to recognize that the most important investment in research is not the money, product, but the people. If the people do not feel engaged in a research from the beginning to delivery if something will work, then we will not be able sustain research for ever. Why would someone want to join a trial in Zimbabwe or a new vaccine or the study of an antibody infusion if they don’t see PrEP which was studied in Zimbabwe being available,” he said.

He added that the science that happens in Zimbabwe has to benefit the country adding that PrEP is an important test case not only in the science, but what comes next after a positive result.

“Will there be guidelines? Will the guidelines be followed by programmes, will the programmes be funded?

“We have to be sure that we are constantly doing both the development and the delivery to ensure that the research can go on,” he added.

To fill up funding gaps, Warren said there is need to look at available research and make the case on why there is need for continued investment.

“We have had great progress in both HIV prevention and in the Aids response generally, now will be the worst time to divert our attention and go elsewhere.

“It clearly takes a global community to support this research and the implementation. It is just not the global fund, it is not PEPFAR, it is what the Zimbabwean country invests in itself, it is what communities invest.

“Sometimes that can come in dollars and sometimes in other forms like human resources, which are more important than financial. It is clear that we need to be more creative in the investment and that means being smart about where the funding comes from, so not just relying on external donors but looking at how domestic financing supports research and product delivery and making sure that we are more efficient with the resources that we have,” he explained.

Getting there?

Zimbabwe is the site for the SAPPH-Ire PrEP demonstration project, looking at how best to roll out PrEP and ARV treatment to sex workers. Results are expected at the end of 2016. PrEP will also be incorporated into the PEPFAR-funded DREAMS initiative. The drug Truvada is registered as treatment. It is not registered for prevention.

Zimbabwe AIDS Prevention Programme at the University of Zimbabwe has also helped to move forward the discussion on PrEP access for serodiscordant couples, and helped ensure that couples counselling guidelines included specific information on helping HIV-negative individuals understand his or her risk.

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