World AIDS Day, 1 December 2021

Articles
Written By Adam Foster

End inequalities. End AIDs.

December 1st is World AIDS Day and is an opportunity to reflect on pharmacological innovations that has turned a once fatal disease into a treatable condition. Infection rates have slowed in recent years due to increase in testing availability, as well as development of antiretroviral therapy and, more recently, pre-exposure prophylaxis (PrEP). [1-3]

Although once a stigmatizing disease present in marginalized communities, growing medical awareness has combated stigma and misinformation around the disease.

However, high unmet need for preventative and efficacious treatments remains, with 38 million people living with HIV in 2021.

Pharmaceutical Innovations in HIV Treatment

1987 marked the FDA approval of the first antiretroviral (ARV) agent to treat HIV, zidovudine. However, key challenges of early single-drug ARV treatments included quick emergence of drug resistance, high pill burden, or severe side effects. Subsequently, it was found that combining two or three classes of ARV drugs combated resistance and improved efficacy, named ART (ARV combination therapy). Currently, more than 30 ART drugs are available, including single fixed-dose combination pills to improve patient’s adherence to treatment. Genvoya (Gilead) and Triumeq (GSK) are among the most widely used HIV ARTs globally. [4-7]

While ARTs have significantly decreased HIV’s clinical burden, drug resistance remains a prominent issue. In 2021, the FDA and EMA approved a first long-acting injectable ARV, Cabenuva, with the promise to improve adherence and prevent drug resistance by ensuring 2 months effective plasma concentration. However, like any innovation in a field with relatively inexpensive standard of care, this long-acting therapy has experienced access issues across markets. Due to Cabenuva’s price premium compared to ARTs, US commercial plans rarely cover it. Notably, in the UK, NICE have recommended the use of Cabenuva for HIV treatment, but only in the with a patience access scheme likely with a confidential price agreement. [8-10]

Pioneering Options for HIV Prevention

In the past decade, Truvada and Descovy (Gilead) were approved as the first preventative PrEP drugs that can stop HIV from spreading through the body in the case of exposure.

While PrEP are considered to be efficacious and adequately safe options in HIV prevention, they face various access challenges across markets. For example, in markets where PrEP is not reimbursed by the national healthcare insurance, such as China, the high out-of-pocket costs and HIV stigma are key challenges for PrEP uptake. Even in markets where PrEP is reimbursed, such as France, Germany or the UK, barriers for drug uptake persist and include the lack of patient awareness, or access obstacles, e.g., agents can be prescribed only by a physician who specialize in HIV, or at a special HIV clinic, which make it more difficult to obtain the agent.

There is still work to be done to remove access barriers to PrEP and achieve UNAIDS goal of eliminating AIDS as a public health risk by 2030.

Future Outlook

  • The evolution of HIV from a progressive infection to a treatable chronic disease has caused a significant shift in payers’ behavior, where they increasingly focus on long-term safety of agents as a differentiation point for access

  • Cabenuva and similar pipeline agents can expect access issues due to the expected premium price to the current standard of care, but head-to-head clinical trials showing superior efficacy over ART could be used as an argument for cost effectiveness

  • Treatments offering a novel mechanism of action targeted at heavily pretreated patients with resistance issues could achieve price premium given the limited patient population and lack of treatment options

  • The anticipated launch of generic treatment options in the next 5 years, such as Descovy or Isentress, will change physician prescribing behavior due to payer pressure to limit costs, but also further erode the price potential for new HIV treatments

  • To increase PrEP uptake in markets with full reimbursement, strategies to increase awareness among high-risk individuals should be implemented, alongside addressing access barriers and making PrEP more easily accessible, or engaging women at risk of HIV

  • Given the focus and public health push for new preventative options, the market access prospects for novel HIV agents is high; however, the broad availability of generics could limit commercial feasibility and potential, which was the case for recent Gilead’s decision not to pursue PrEP marketing authorization for Descovy in the EU

Kelly Litts [Left], Analyst, Windrose Consulting Group

Agatha Cimbalova [Right], Analyst, Windrose Consulting Group

Adam Foster
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