Cabotegravir: What are we waiting for?
In 2020, around 1.5 million people were newly infected with HIV. Global targets endorsed at the World Health Assembly 2022 aim to reduce new HIV infections from 1.5 million to under 370,000 by 2025 and under 335,000 by 2030. In order to meet these targets, it will be essential to expand access to HIV prevention medicines known as pre-exposure prophylaxis (PrEP).
There are currently three types of PrEP that have been approved for use: oral PrEP, dapivirine (DPV) vaginal ring and long-acting cabotegravir (CAB-LA).
Oral PrEP is the method currently routinely offered. While it is highly effective, it involves taking a pill daily—which can be challenging for some people. Long-acting forms of PrEP such as DPV vaginal ring and CAB-LA offer options that can facilitate adherence for people at risk of HIV infection.
CAB-LA is patented and produced by ViiV Healthcare, an offshoot of pharmaceutical corporations Pfizer, GlaxoSmithKline and Shionogi. Delivered as an injection every two months, it is the most effective means to prevent HIV infection and can help turn the tide against new HIV infections globally. However, a number of factors currently constrain access to this drug in places where it is needed most, threatening progress towards global targets for HIV prevention.
In this Issue Brief, we describe CAB-LA’s ongoing implementation and access challenges, and make recommendations to ViiV Healthcare to make the medicine available and affordable to people who need it the most.
Access to CAB-LA: Current situation and challenges
Pricing transparency: CAB-LA is priced at US$3,700 per vial, or $22,200 per person per year (6 vials) in the US. While ViiV’s stated policy is to provide their medicines “at cost” for low-income, least developed and sub-Saharan African countries, they have yet to publicly announce what that price is.
Registration: ViiV has registered CAB-LA in the US and filed to register in only eight other countries. Many countries with a high burden of existing and new HIV infections are not included in this list.
Supply: Given the delay in voluntary licensing and potential generic entry into the market, ViiV will likely be the sole supplier of CAB-LA in the short term. This comes with the risk of insufficient supply.
CAB-LA is a game-changer in HIV prevention and the most effective form of PrEP currently available to people at high risk of HIV. However, the lack of transparency around the pricing and registration plans of the drug, unnecessary delays over agreeing a voluntary license, and implementation-science conditions have acted as barriers to access to this injectable, particularly in low- and middle-income countries (LMICs). If allowed to continue, this could result in potentially millions of additional HIV infections. To address this dangerous trend, and to make CAB-LA available and affordable to people who need it the most, we urge ViiV to:
- Publicly announce their non-profit price of CAB-LA for low-income, least-developed and sub-Saharan African countries, as well as the price for countries not eligible for the non-profit price
- Register the drug widely, including in countries with a high burden of existing and new HIV infections
- Allow organisations and national programmes to buy CAB-LA directly without constraining them with implementation-science requirements
- Ensure sufficient manufacturing capacity