Groundbreaking news emerges from the global health community: a powerful new drug offering nearly flawless protection against H.I.V. will soon be accessible for just $40 per patient each year in developing nations. This significant breakthrough ignites fresh hope in the decades-long battle to conquer the H.I.V. epidemic worldwide.
While existing treatments effectively manage H.I.V., a definitive cure remains elusive. This reality underscores the critical importance of affordable, widespread prevention to halt the virus’s spread. Annually, approximately 1.3 million individuals globally still contract H.I.V., highlighting the urgent need for accessible preventative measures.
The revolutionary drug, lenacapavir, requires only two injections every six months for full efficacy. Philanthropic organizations recently announced two crucial agreements that will bring the annual cost of these life-saving shots down to match that of daily oral H.I.V. prevention pills. This pricing makes lenacapavir a genuinely viable and impactful option for countries facing significant resource limitations.
Former President Bill Clinton, co-founder and board chair of the Clinton Health Access Initiative – a key player in negotiating one of these new partnerships – enthusiastically declared, ‘This is a game-changer.’
He further emphasized that the new approach ‘simplifies prevention for patients, doctors, and health systems alike,’ streamlining efforts across the board.
Health ministers across African nations have warmly received the announcement of this significantly reduced price.
Dr. Sabin Nsanzimana, Rwanda’s health minister, lauded the development, stating, ‘By making lenacapavir available soon for just $40 a year, we’re witnessing remarkable progress in long-acting H.I.V. prevention.’
However, these promising agreements arrive amidst a challenging global landscape. Significant budget reductions in global health programs are compelling low- and middle-income countries to confront difficult choices in allocating funds for their most pressing health crises, such as malaria, tuberculosis, and malnutrition.
Mitchell Warren, executive director of the H.I.V. prevention organization AVAC, raised a critical question: ‘Where are those dollars and rands and shillings going to come from to actually procure the product, even if it’s $40 per person per year?’
While daily oral pills offer excellent H.I.V. prevention, adherence can be challenging for many. Moreover, issues of safety, privacy, and societal stigma frequently act as barriers, especially for women in lower-income regions.
Fortunately, long-acting medications effectively bypass many of these obstacles. Lenacapavir, developed by Gilead Sciences, stands as the second such long-acting option for H.I.V. prevention. Its counterpart, cabotegravir (marketed as Apretude by ViiV Healthcare, GSK’s H.I.V. division), requires injections every two months.
Lenacapavir’s remarkable efficacy, demonstrated by over 99 percent protection in clinical trials with just two injections annually, has generated immense optimism within the public health community.
Jirair Ratevosian, a senior fellow at the Duke Global Health Institute, expressed profound excitement, stating, ‘We have the recipe here for a really successful once-in-a-lifetime shift in the way we’ve done H.I.V. prevention, and that’s really exciting.’
Historically, both long-acting drugs appeared financially inaccessible to the majority of nations. For instance, when lenacapavir received U.S. approval in June, Gilead announced its preventative version, Yeztugo, with a steep list price of $28,218.
Cabotegravir’s list price is similarly high. However, British researchers had previously calculated that lenacapavir could potentially be manufactured for as little as $40 per patient annually, a figure now realized through these new partnerships.
Last October, Gilead had already announced plans to license six companies to produce generic versions of the drug for 120 low- and middle-income countries. Significantly, the newly agreed-upon $40 annual price will exclusively apply to these specified nations.
Unitaid, an international body dedicated to making vital medicines affordable, collaborated with the Clinton Health Access Initiative and the Wits RHI research institute to broker a partnership with India’s Dr. Reddy’s Laboratories, a leading generics manufacturer.
In parallel, the Gates Foundation independently secured a separate agreement for lenacapavir with Hetero, another India-based company recognized as the world’s largest producer of H.I.V. medications. Despite separate negotiations, both organizations carefully coordinated their announcements to maximize impact.
Dr. Philippe Duneton, executive director of Unitaid, emphasized the goal: ‘What we want is to have a generic market that is the right size, the right price, but also to have some competition’ among manufacturers.
Carolyn Amole, a vice president at the Clinton Health Access Initiative, clarified that the $40 price point is merely the beginning of their journey.
She stated, ‘What we have done with this price agreement is get the product on a pathway to even further price reduction and greater affordability,’ expressing confidence that this reduced cost will empower countries to move closer to self-reliance in H.I.V. prevention.
Generic formulations of lenacapavir are slated for availability beginning in 2027. Complementing this, both The Global Fund and the President’s Emergency Plan for AIDS Relief (PEPFAR) have unveiled a strategy to distribute lenacapavir to two million individuals across as many as twelve countries by 2028.
However, to truly achieve epidemic control in sub-Saharan Africa, an estimated 40 million people require access to these crucial preventive medications.
Asia Russell, executive director of the advocacy group Health GAP, pointed out that PEPFAR possesses allocated prevention funds that could serve as ‘bridge’ funding until generic versions become widely available.
She critically added that the State Department’s initiative to reach two million people with the drug is merely a ‘vanity project’ that will make an insignificant impact on the overall need, lamenting that ‘The U.S. has responded to the science with a whimper instead of a roar.’
The State Department did not immediately provide a response when contacted for comment.
It’s important to note that these new agreements do not extend to certain middle- and high-income countries, such as Brazil, which collectively represent approximately 20 percent of new H.I.V. infections globally.
Ms. Russell concluded by emphasizing that ‘The rest of the world needs to benefit from that price as well.’