The 24th International AIDS Conference is in Montreal, Canada, from 29 July - 2 August 2022.
The figures of the fight against HIV show we're moving backwards: the response to the virus is losing coverage and pace. MSF teams witness increased difficulties to provide people living with HIV with the necessary prevention, diagnosis and treatment. Our teams report less HIV testing, less treatment initiation, more patients on treatment lost to follow up, and reduced prevention programmes. This is largely due to shortfalls in funding for key HIV interventions.
Funding gaps for medical supplies are resulting in stock outs, insufficient availability of drugs, and increased financial barriers for patients. The lack of resources forces rationing of services, and certain communities or people get no or substandard care. The shortfalls also mean that innovative approaches, so important to keep making progress, cannot be implemented.
With less people initiating antiretroviral treatment and more people on treatment lost to follow-up, more people living with HIV present at MSF-supported clinics with worrying signs, such as low CD4 count* and opportunistic infections, which put them at greater risk of dying. This is extremely concerning.
These disturbing slide backs are partially due to negative effects of the worldwide COVID-19 pandemic, and they are compounded by significant economic problems and cutbacks in international aid in many countries, notably for health. Subsequently, the international pledges for the upcoming replenishment of the Global Fund in September 2022 are crucial to make or break the HIV response over the next few years. There is also a need for re-engagement of other donors and implementers.
Current situation - what's needed?
The international donor community has made political and moral commitments to curb the HIV pandemic and bring it under control. Today, we are not making progress - instead, we're sliding back. In 2022, the replenishment of the Global Find presents an opportunity to correct that.
However, the current ask of the Global Fund is not including the additional needs and necessary catch-up efforts following the COVID-19 pandemic. Moreover, the money the Global Fund will ask for in September 2022 is meant for 2024-2026, but already today there is an urgent need for additional resources to bridge the most pressing shortfalls. With competing priorities and economic problems, affected countries face difficulties to mobilise the necessary domestic resources. This will likely result in even more gaps, if international donors do not step in.
This is the time to re-commit to reversing the dreadful current trends that puts the lives of millions of people living with HIV in the balance. Strong political commitment from donor countries is more needed than ever to stop eroding gains and get the response to HIV back on track.
Too many patients with AIDS are detected too late. Often diagnostics and medicines to treat them are not available, or come at high costs to the patients, unaffordable for most. This leads to substandard and incomplete care. The delay also means more severe complications, longer hospital stays and higher mortality.
While tuberculosis is acknowledged as the leading cause of death among people living with HIV, it is essential that diagnostic and therapeutic tools are available for effective and early detection and treatment of cryptococcal meningitis, the neglected, second-leading cause of death among people living with HIV. National programmes, UNAIDS, World Health Organization (WHO) and other programme funders and implementers need to be held accountable to setting and achieving annual AIDS-related deaths to under 250,000 people by 2025, and to specifically reduce deaths from cryptococcal meningitis by 50 per cent in 2025 and 90 per cent by 2030.
Equally important is the support to adapted models of care that enable early detection of advanced HIV disease at basic health care centres, such as clinics, or at community level. Hospitals and basic health care sites need to be able to do a rapid assessment, to immediately start treatment and avoid mortality. COVID-19 increased barriers to retention in care and timely initiation, so there is an urgent need to facilitate people living with HIV to (re-)start antiretroviral treatment.
CAB-LA stands for cabotegravir - long acting. This new antiretroviral drug is an important preventive tool for use in pre-exposure prophylaxis (PrEP), to prevent new HIV infections in people at high risk. The announcement of WHO at AIDS 2022 that CAB-LA will be included in its HIV PrEP guidelines is important, but now the conversation on affordability and availability for rollout should start.
MSF wants to pilot a project using CAB-LA for people at highest risk of infection, key populations and young girls in particular, in Mozambique and Eswatini. Implementing innovative tools like CAB-LA can be a real game-changer, and they are urgently needed to reach the global targets to reduce new HIV infections.
Community-led interventions are crucial in the HIV response. They bring prevention, diagnosis and treatment closer to patients. Community monitoring of the availability and access to essential medical supplies can leverage system improvements.
Much of the success in the results obtained in the HIV response is possible due to the work done by civil society organisations. They are crucial to overcome the barriers to care when health systems are under-resourced, substandard, or ill-adapted to the needs of people living with HIV.
As the World Health Organization (WHO) recommended long-acting injectable cabotegravir (CAB-LA) for HIV prevention, and the Medicines Patent Pool (MPP) and UK pharmaceutical corporation ViiV Healthcare announced an agreement to open up generic production and supply of CAB-LA in 90 countries, Doctors Without Borders (MSF) called on governments in low- and middle-income countries (LMICs) to urgently include this drug in national HIV guidelines and accelerate its rollout to prevent HIV transmission.
Administered as an injection every two months, CAB-LA is the most effective form of pre-exposure prophylaxis (PrEP) for people at high risk of HIV. However, as detailed in a new MSF report released ahead of the 2022 International AIDS Conference, the lack of transparency around the pricing and plans for registration of the drug and implementation-science conditions for procurement, set by ViiV, may still pose as barriers to access to this medicine, particularly in LMICs.
“WHO’s recommendation for use of long-acting injectable cabotegravir offers a more effective option for people in countries like Mozambique, where there is a high prevalence of HIV, who would hugely benefit from rollout of this drug to help reduce new infections,” said Dr Zaid Seni, Medical Activity Manager, MSF Mozambique. “While the current oral preventive treatment available in low- and middle-income countries is effective, taking a daily pill can be challenging for some. CAB-LA offers a more discreet option that can facilitate better adherence for people at risk of HIV infection. We urge ViiV to make the drug available at an affordable price to support timely use of this game-changing drug to help avoid millions of new HIV infections.”
ViiV holds patents on CAB-LA in multiple developing countries. The patent monopolies of the pharmaceutical corporation may block access to more affordable generic formulations in those countries and allow ViiV to sell CAB-LA at high prices, keeping the medicine out of reach for many who need it unless licenses are issued to generic manufacturers. Today, at the 2022 International AIDS Conference, ViiV and MPP announced a voluntary license on CAB-LA.
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“Today’s announcement on ViiV’s agreement with MPP is a welcome yet limited step given its restrictive geographical scope. The license allows only up to 3 generic companies globally to produce and supply,” said Leena Menghaney, South Asia Head, MSF Access Campaign. “It is disappointing to note that a number of developing countries with generic manufacturing capacities in Latin America and Asia are currently excluded from this license agreement.”
CAB-LA was approved for the prevention of HIV infection by the US Food and Drug Administration (FDA) in December 2021, and ViiV currently charges over R62,000 (US$3,700) per vial in the US more than R371,000 ($22,200 per person per year). Research from the Clinton Health Access Initiative (CHAI) has shown that generic manufacturers could produce this drug for around R43,87 ($2.60) per vial (less than R337 / $20 per person per year). Although ViiV has publicly said they would provide CAB-LA for their at-cost price in many LMICs, they have yet to announce the price.
Another major limitation is that ViiV currently makes this drug available in LMICs only under its special program, wherein the drug is donated based on approval by the corporation to the organisations submitting protocols for studying the drug for PrEP. Granting access under research conditions may deny the most vulnerable populations, particularly in humanitarian settings, from accessing CAB-LA.
“Following WHO’s recommendation for the use of CAB-LA as PrEP, ViiV must take immediate steps to publicly announce the price for this drug for all low- and middle-income countries and ensure sufficient supply everywhere by allowing procurement without any conditions to treatment providers and countries, until generics are available,” said Jessica Burry, HIV/HCV Pharmacist, MSF Access Campaign.
