Activists attending the International AIDS Conference in Munich Germany asked the manufacturer of injection Lenacapavir (LEN), which was recently proven to be safe and highly effective at preventing HIV to reduce its prices to make it affordable for all.
The drug, which is manufactured by a US Company Gilead Sciences was recently found to be one hundred percent effective as a Pre-exposure prophylaxis (PrEP) in a clinical trial where participating women in sub-Saharan Africa were given an injection twice a year. Now, activists have expressed concern that the company has not released any concrete plans for global access to the drug.
“Lenacapavir could be life-changing for people at risk of getting HIV and could reverse the epidemic if it is made affordable in the countries with the highest rate of new infections,” said Dr Helen Bygrave, chronic disease advisor at MSF’s Access Campaign.
“MSF would be eager to start offering people lenacapavir in our medical programs, but to do so, we need Gilead to license the drug to other producers through the Medicines Patent Pool to allow generic production and supply in all low- and middle-income countries.
However, in an earlier statement released in late June, Gilead had indicated that they developing a strategy to enable broad, sustainable access globally. A key component of this strategy they said was to deliver lenacapavir sustainably and in sufficient volumes if approved to high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries including in Uganda where part of the clinical trial took place.
They said they were developing a robust direct voluntary licensing program to expedite access to low-cost versions of lenacapavir in high-incidence, resource-limited countries and that they were moving with urgency to start negotiating these contracts.
However, activists said Gilead has a long history of over-pricing their products affecting access. For instance, Asia Russell, the Executive Director of an NGO Health GAP says while Len for HIV prevention is a potentially pandemic-defeating intervention, they fear the pharmaceutical company might undermine global access by excluding middle-income countries from voluntary licensing deals and artificially restricting licensees.
She called upon governments to break Gilead’s monopoly by issuing non-voluntary licenses, wherever Gilead’s patents present a barrier.
Meanwhile, according to research presented at the AIDS Conference on Tuesday, generic lenacapavir can be produced at a price one thousand times less than Gilead’s price. It’s estimated that one year’s supply of Lenacapavir could be sold at a profit for under $100 per person per year, but Gilead currently charges over $42,000 per year in the US.
Activists fear that this kind of pricing undermines the potential of this scientific breakthrough and slows the global effort to turn the tide on HIV and AIDS. In Uganda, clinical trials for the injection were carried out at three sites by researchers at Makerere University John Hopkins University (MUJHU) Research Collaboration.
Speaking at the conference on Wednesday, Sharon Lewin, the President of IAS – the International AIDS Society said the injection has a huge a huge public health potential and could help accelerate global progress in HIV prevention.
“We all owe a debt of gratitude to the thousands of young women in South Africa and Uganda who volunteered to be part of this study. Now we eagerly await results from PURPOSE 2, which is assessing twice-yearly lenacapavir for HIV prevention in other populations and countries. In the meantime, all stakeholders must work together to accelerate equitable delivery of existing HIV prevention options, and do more to prepare for future options, such as lenacapavir for PrEP”.