A step forward to prevent HIV, but short

Last Wednesday, within the framework of the World AIDS Conference being held these days in Montreal, Canada, important news was announced for the fight against HIV and global health: a voluntary license agreement between the pharmaceutical company ViiV and the United Nations Patent Fund (MPP) to expand access to an innovative drug that prevents HIV infection in people highly exposed to the virus and at greater risk of becoming infected.

It is the long-acting injectable cabotegravir (CAB-LA): a drug approved for pre-exposure prophylaxis (PrEP), which is administered every two months and which today would be the most effective alternative to other types of PrEP : an oral pill that must be taken every day – with the adherence problems that this entails – or the dapivirine vaginal ring.

The advantage of being able to be used by anyone and of being administered bimonthly instead of every day makes CAB-LA a tremendously interesting drug that, added to other prevention strategies and tools, could help reduce the incidence of HIV.

Not long ago: the latest Onusida report warns that the fight against HIV and the progress made in recent decades are in danger.

To go no further: the number of new infections globally decreased by just 3.6% between 2020 and 2021, the smallest annual decline since 2016. Regions such as Eastern Europe and Central Asia, the Middle East, North Africa, and the Americas America has experienced a surge in new infections for years.

The long-awaited end of the AIDS pandemic as a public health problem in 2030 seems almost unattainable.

A large number of middle-income countries where there are millions of people who could benefit from the drug are left out.

For example, to most of Latin America, including countries like Brazil

The agreement on CAB-LA comes in record time: the drug was approved in the United States just seven months ago.

With the voluntary license, ViiV, the pharmaceutical company that markets it and currently holds a monopoly on the drug, will allow a select number of manufacturers to develop, manufacture and supply generic versions of the drug in 90 low-, middle- and low-income countries, including all of sub-Saharan Africa.

Undoubtedly, this decision will help millions of people in very vulnerable situations and at high risk of infection to avoid it.

However, in a deeper analysis, the agreement contains some shadows that civil society organizations must highlight.

First of all: a large number of middle-income countries in which there are millions of people who could benefit from the drug are left out.

For example, to most of Latin America, including countries like Brazil (a decision that has generated great controversy, since ViiV relied on the volunteering of men who have sex with other men and transgender women for its clinical trials in the country ).

In addition, the number of laboratories that will be able to manufacture the generic drug is very scarce;

just three.

Second, there is little certainty about the transfer of technology and

(that is, about the knowledge necessary to be able to manufacture and develop the drug) to these laboratories.

According to the text, they are entirely at the discretion of the pharmacist.

Only an open and ambitious transfer of knowledge and technology will enable manufacturers to develop the generic drug quickly

We will have to wait to see what happens.

Only an open and ambitious transfer of knowledge and technology by ViiV will enable generic manufacturers to develop the drug quickly enough to introduce this breakthrough in the fight against HIV globally.

The challenges that the tests required for complex generics such as this one may pose, together with the timeframes of the administrative processes that go from the license agreement to the effective commercialization, could delay the arrival of generic CAB-LA by four or five years.

This being so, we come to the third point, which is fundamental.

ViiV has promised to offer the medicine at cost price in the countries covered by the pact until the arrival of generics, but the price it will stipulate is unknown.

The concern is that in the United States the established price is almost 22,000 euros per year per person.

In this sense, civil society organizations are asking ViiV to carry out an exercise in transparency and announce the cost of production.

The price for these countries should be similar to that of oral PrEP and in no case should it be higher than 60 euros per person per year.

In fact, recent research suggested that if generics were allowed in, these manufacturers could produce it for around €2.54 per vial – less than €20 per person per year.

Finally, ViiV must guarantee uninterrupted supply to cover global needs until the generic versions that the license allows are available.

Only in this way, progress and discoveries will be a real breakthrough.

Because... what is the use of having an innovative drug capable of changing the course of a pandemic if the vast majority of people who should be able to access it cannot?

Jaime Manzano

and

are researchers and journalists at the NGO Salud por Derecho.

You can follow PLANETA FUTURO on

to our 'newsletter'

.