ViiV Healthcare 允許 90 個國家/地區使用通用版本的 HIV 預防藥物
同意允許負擔得起的愛滋病毒預防注射劑的生產被批評為過於有限
資料來源：勞拉·洛佩茲·岡薩雷斯 / 2022 年 7 月 28 日 / aidsmap / 財團法人台灣紅絲帶基金會編譯
ViiV Healthcare 的 Deborah Waterhouse 和藥品專利池的 Charles Gore 在 AIDS 2022 上宣布了該協議
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作為與藥品專利池簽訂的新許可協議的一部分，製藥商 ViiV Healthcare 將允許 90 個國家/地區獲得其雙月 HIV 預防注射的負擔得起的通用版本。儘管如此，全球只有三個仿製藥生產商將被允許根據協議生產這種藥物，該協議因其廣泛度的局限性而受到批評。
ViiV Healthcare 已向藥品專利池授予長效可注射 cabotegravir 的自願許可，該專利池與製藥公司就優先藥物的自願許可進行談判，以增加准入。該協議將允許低收入和中低收入國家以及所有非洲國家，無論收入水平如何，都可以在可用時獲得負擔得起的通用版本的愛滋病毒預防藥物。
預計仿製藥生產商將需要數年時間才能根據協議提高產量。與此同時，ViiV Healthcare 首席執行官 Deborah Waterhouse 表示，該公司將在許多國家推出「過渡性」注射藥的降低價格。沃特豪斯沒有具體說明哪些國家將獲得折扣價，她拒絕透露最終價格是多少。然而，沃特豪斯確實表示它將在「數十美元」的範圍內。
「我很高興，因為這可能會改變遊戲規則，使受愛滋病毒影響最嚴重的國家能夠獲得新的愛滋病毒預防藥物」，沃特豪斯說。「我很自豪，因為這確實體現了 ViiV 在開發高度創新的藥物以及與合作夥伴合作以確保廣泛使用方面所發揮的作用」。
她繼續說：「今天的公告向那些參與我們看到強大持續療效的試驗者致敬」。
在男同性戀和雙性戀男性、跨性別女性和順性別女性中進行的臨床試驗發現，與接受口服暴露前預防 (PrEP) 的同齡人相比，接受 HIV 預防注射的人感染 HIV 的可能性降低 66% 至 89%，部分原因是雙月注射比每日服藥更容易服用。
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藥品專利池如何運作
藥品專利池是聯合國支持的公共衛生組織，旨在改善低收入和中等收入國家獲得負擔得起的、質量有保證的藥品的機會。它透過首先確定這些國家急需但由於專利使政府購買它們非常昂貴而無法獲得的藥物來做到這一點。
然後，它與擁有特定藥品專利的製藥公司聯繫，並要求他們頒發許可證，允許藥品專利池在專利到期之前生產該藥品的通用版本。他們主張這一點的理由是，頒發許可證將對公眾健康大有裨益，並且他們試圖確保許可證的措辭能夠為盡可能多的國家帶來最大的健康益處。
一旦藥品專利池獲得許可，他們就會將製造分包給幾家仿製藥公司。選擇這些公司的依據是它們在製造高質量仿製藥方面擁有良好的記錄，並且在許可證所涵蓋的國家/地區擁有市場存在。
生產相同藥物的仿製藥的公司越多，隨著公司競相讓政府購買其藥物，價格就越有可能下降。
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預防愛滋病毒藥物的費用是否可以低至每人每年 13 英鎊？
今年早些時候，ViiV Healthcare 發表聲明稱，經過「嚴格評估」，沒有發現其 HIV 預防藥物的潛在仿製藥製造商。因此，該公司表示，它不會像之前對其抗反轉錄病毒藥物 dolutegravir 所做的那樣，為長效cabotegravir尋求自願許可。
在公眾壓力下，ViiV 在 5 月訴說道，先前所發表聲明實際上係對自願許可持開放態度，以增加達成取得的機會。
來自社區治療網絡 AfroCAB 的 Jacque Wambui 表示，他們很高興他們的倡導沒有被忽視。
她在一份聲明中說：「這項關於長效cabotegravir仿製藥許可的公告無疑將對我們社區的愛滋病毒預防工作產生變革性影響」。「我們現在急切而焦急地等待一個過渡價格，以便現在在低收入和中等收入國家獲得長效cabotegravir」。
根據無國界醫生組織獲取運動，目前，長效cabotegravir在美國的官方價格為每人每年 22,000 美元。然而，全球衛生組織克林頓健康獲取倡議估計，注射劑的生產成本約為每人每年 16 美元——低於更常用的 PrEP 片劑的價格。
沃特豪斯曾表示，美國的價格不能廣泛概括。迄今為止，美國是唯一批准該藥物用於 PrEP 的國家；一些進行了 cabotegravir PrEP 研究的國家正在提交監管文件。
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維權人士表示，ViiV 對許可證的改頭換面受到歡迎，但還不夠
儘管如此，ViiV Healthcare 的協議仍被批評為有限且具有排他性。
Médecins Sans Frontières Access Campaign 的 Yuan Qiong Hu 表示，將只允許三個仿製藥製造商為協議涵蓋的 90 個國家生產藥品。儘管該協議無論收入水平如何，涵蓋低收入和中低收入國家以及所有非洲國家，但它不包括許多具有成熟製藥能力和需要該藥物的人口的國家。
擁有超過一百萬愛滋病毒感染者的俄羅斯被排除在該協議之外。同樣，阿爾巴尼亞、亞塞拜然和哈薩克斯坦等許多中歐國家也不在該協議範圍內。烏克蘭被包括在交易中，但這個飽受戰爭蹂躪的國家將成為向公共部門 HIV 項目支付 ViiV 特許權使用費總額的 5% 的國家之一。
「這是一個受歡迎的步驟，但仍然非常有限」，胡解釋道。「它排除了相當多具有製造能力的發展中國家，特別是拉丁美洲和亞洲」。
「巴西、墨西哥、智利、哥倫比亞——所有這些國家都有能力，但也獲得了專利 [用於長效注射 cabotegravir] 」，胡繼續說道。「這意味著他們將不得不等到大約 2026 年或 2027 年才能獲得通用版本」。
即使這些國家的仿製藥製造商贏得了生產仿製藥的三個許可證之一，他們也無法在當地分銷這些產品。
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注射 PrEP 的降價其價格可能仍然太高
Health Gap 執行董事 Asia Russell 認為，在中國、印度和巴西等擁有大量愛滋病毒感染者的國家，ViiV Healthcare 可能會擴大愛滋病預防注射的專利。
「我們知道南非將被包括在這筆交易中」，她說。「其他中等收入國家將無法承受極高的價格，例如巴西，跨性別社區勇敢地參與了這項臨床研究」。
聯合國愛滋病規劃署對該協議表示歡迎，但與活動人士一起呼籲 ViiV 降低價格，使其與愛滋病預防藥丸的價格相當，這是一種tenofovir disoproxil/emtricitabine (TDF/FTC) 的二合一組合。有報導稱，美國總統愛滋病緊急救援計劃 (PEPFAR) 等主要捐助者表示，藥物的價格必須降至這一水平，然後才能為受愛滋病毒影響最嚴重的國家採購。
「由於仿製藥生產需要幾年時間才能上線，ViiV 承諾以盡可能接近當前口服 PrEP 成本（目前約為 60 美元）的價格在中低收入國家銷售長效cabotegravir至關重要。這將使 ViiV 能夠預防數百萬新的 HIV 感」，聯合國愛滋病規劃署副執行長 Matthew Kavanagh 博士在一份聲明中說。
聯合國機構還呼籲擴大該協議。
「將許可證擴展到指定的 90 多個國家/地區至關重要」，卡瓦納說。「中等收入國家現在是大多數新的愛滋病毒感染發生地，也是許多最容易感染愛滋病毒和最需要獲得長效抗反轉錄病毒藥物的關鍵人群的家園。但是，儘管對負擔得起的新健康技術有相當大的需求，但許多並未包含在該許可證中」。
沃特豪斯回應說，ViiV Healthcare 仍然致力於擴大准入，包括尋求世界衛生組織 (WHO) 的資格預審。這是重要的一步，特別是在監管能力薄弱和依賴捐助者的國家。
沃特豪斯在新聞發布會上說：「我們將盡可能快地逐個國家採取行動，要麼透過世衛組織的資格預審方法合作，要麼在我們獲得監管批准後與各國政府進行逐個國家對話」。「我從未遇到過更複雜的情況——我們必須採取定制的、逐個國家的方法，只有這樣我們才能真正為每個市場找到正確的解決方案」。
ViiV Healthcare to allow 90 countries to access generic versions of HIV prevention shot
Agreement to allow affordable production of HIV prevention shot criticised as too limited
Laura Lopez Gonzalez / 28 July 2022 / aidsmap
Deborah Waterhouse of ViiV Healthcare and Charles Gore of the Medicines Patent Pool announce the agreement at AIDS 2022
Drugmaker ViiV Healthcare will allow 90 countries to access affordable generic versions of its bi-monthly HIV prevention shot as part of a new licensing agreement with the Medicines Patent Pool. Still, just three generic producers globally will be allowed to produce the shot under the agreement, which has been criticised for its broad limitations.
ViiV Healthcare has granted a voluntary licence for long-acting injectable cabotegravir to the Medicines Patent Pool, which negotiates with pharmaceutical companies for voluntary licences on priority drugs to increase access. The deal will allow low- and lower-middle income countries as well as all African countries regardless of income level to access affordable generic versions of the HIV prevention shot when available.
It is anticipated it will take several years for generic producers to ramp up production under the agreement. In the meantime, ViiV Healthcare CEO Deborah Waterhouse says the company will introduce reduced “bridging” prices for the injection in many countries. Waterhouse did not specify which countries would receive the discounted price and she declined to say what the final price would be. Waterhouse did however say it would be in the “tens of dollars” range.
“I’m delighted because this is potentially a game changer for enabling access to a new HIV prevention medicine in countries most affected by HIV,” Waterhouse said. “I’m proud because this really exemplifies even the role that ViiV plays in developing highly innovative medicines and then working with partners to ensure that broad access is there.”
She continued: “Today’s announcement honours those who participated in trials where we saw strong sustained efficacy.”
Clinical trials conducted among gay and bisexual men, transgender women and cisgender women found that those who received the HIV prevention shot were 66 to 89% less likely to contract HIV than their peers who took oral pre-exposure prophylaxis (PrEP), in part because the bi-monthly shots were easier to take than daily medication.
How the Medicines Patent Pool works
The Medicines Patent Pool is a UN-backed public health organisation set up to improve access to affordable, quality-assured medicines in low- and middle-income countries. It does this by first identifying medicines which are greatly needed but inaccessible in these countries due to their patent making them very expensive for governments to buy.
It then approaches the pharmaceutical company that owns the patent for a specific medicine, and requests that they issue a licence which would allow the Medicines Patent Pool to manufacture generic versions of the medicine before the patent expires. They argue for this on the basis that issuing a licence would be of substantial benefit to public health, and they try to ensure that the licences are worded in a way that achieves the greatest health benefit for as many countries as possible.
Once the Medicine Patent Pool has the licence, they sub-contract manufacturing to several generic pharmaceutical companies. These companies are chosen on the basis that they have a track record of manufacturing high-quality generic drugs and have a market presence in the countries covered by the licence.
The more companies produce generic versions of the same medicine, the more likely prices will reduce as companies compete to have their medicines purchased by governments.
Could the HIV prevention shot cost as little as £13 per person per year?
Earlier this year, ViiV Healthcare released a statement that a “rigorous assessment” had found no potential generic manufacturers for its HIV prevention shot. As a result, the company said it would not be pursuing voluntary licences for long-acting cabotegravir as it had done previously with its antiretroviral drug dolutegravir.
Following public pressure, in May ViiV recounted, issuing a statement that it was in fact open to voluntary licences to increase access to the shot.
Jacque Wambui from the community treatment network AfroCAB said they were glad that their advocacy had not gone unheard.
“This announcement regarding the generic licensing of long-acting cabotegravir will undoubtedly have a transformative impact on HIV prevention efforts in our communities,” she said in a statement. “We now eagerly and anxiously await a bridging price to make long-acting cabotegravir accessible in low and middle-income countries NOW. “
Currently, long-acting cabotegravir’s official price in the United States is $22,000 per person annually, according to the Médecins Sans Frontières Access Campaign. However, the global health organisation the Clinton Health Access Initiative has estimated that injection could be produced for about $16 per person per year – less than the price of more commonly used PrEP tablets.
Waterhouse has said that prices in the United States are not broadly generalisable. So far, the United States is the only country to approve the drug for PrEP; regulatory submissions are ongoing in several countries where studies of cabotegravir PrEP were conducted.
ViiV about-face on licences welcomed, but not enough, activists say
Still, ViiV Healthcare’s agreement has been criticised as limited and exclusionary.
Just three generic manufacturers will be allowed to produce the medicines for the 90 countries covered in the agreement, says Yuan Qiong Hu of the Médecins Sans Frontières Access Campaign. While the deal covers low- and lower-middle income countries as well as all African countries regardless of income level, it excludes many countries with established pharmaceutical capacity and populations needing the drug.
Russia, home to more than one million people living with HIV, is excluded from the deal. Similarly, many central European countries such as Albania, Azerbaijan, and Kazakhstan fall outside the agreement. Ukraine is included in the deal but the war-torn country will be among the ten countries that will pay ViiV royalties totalling 5% of net sales to public sector HIV programmes.
“It’s a welcomed step, but it’s still quite limited,” Hu explains. “It has excluded quite a few developing countries with manufacturing capacity, particularly in Latin America and Asia.”
“Brazil, Mexico, Chile, Colombia — all these countries have capacity but also have had patents granted [for long-acting injectable cabotegravir],” Hu continues. “This means they will have to wait until about 2026 or 2027 to get access to generic versions.”
Even if generic manufacturers in countries like these win one of the three licences to produce generic versions, they would not be able to distribute these locally.
Reduced price for injectable PrEP may still be too high
In countries with huge numbers of people living with HIV — such as China, India and Brazil — ViiV Healthcare will likely extend patents on the HIV prevention injection, Health Gap executive director Asia Russell believes.
“We know that South Africa is going to be included in this deal,” she says. “Other middle-income countries won’t be able to afford extremely high prices such as Brazil, where trans communities bravely participated in this clinical research.”
UNAIDS welcomed the agreement but joined activists in calling for ViiV to lower the price to be comparable to that of the HIV prevention pill, a two-in-one combination of tenofovir disoproxil/emtricitabine (TDF/FTC). There are reports that major donors such as the United States President’s Emergency Plan for AIDS Relief (PEPFAR) have said the price of the shot must fall to this level before they will procure for countries hardest hit by HIV.
“As generic production will take several years to come online, it is crucial that ViiV commit to sell long-acting cabotegravir in low- and middle income countries at a price as close as possible to the current cost of oral PrEP—currently approximately $60. This would enable ViiV to prevent millions of new HIV infections,” UNAIDS Deputy Executive Dr Matthew Kavanagh said in a statement.
The UN agency also called for the agreement to be expanded.
“It is vital that the license be extended to more than the 90 countries named,” Kavanagh said. “Middle-income countries are now where the majority of new HIV infections occur and home to many of the key populations most at risk of HIV and who most need access to long-acting antiretrovirals. But many are not included in this license despite considerable need for affordable new health technologies.”
Find out more: Just six injections a year can prevent HIV: here’s what it will take for the world to afford them
Waterhouse responded by saying that ViiV Healthcare remains committed to broader access, including by pursuing World Health Organization (WHO) prequalification. This is an important step, particularly in countries with weak regulatory capacity and who are donor-dependent.
“We’ll be moving as fast as we can country by country, either in partnership through the WHO prequalification approach, or country by country dialogue with governments as we secure regulatory approval,” Waterhouse told a press conference. “I’ve never been involved in a situation more complex – we have to take a bespoke, country by country approach and only then will we actually find the right solution for each market.”