This HIV Prevention Drug Could Change the Game

A new, long-lasting drug could be a game-changer for preventing HIV infections, experts say.

Advocates are hopeful that those who need it most in low- and middle-income countries will not have to wait for it as long as they have for previous HIV drugs. But questions remain about access and price.

The drug is called cabotegravir and is delivered as a shot once every other month. In clinical trials, it did a better job at preventing infection than another option — a pill taken once a day.

The bimonthly injection seems to be an easier treatment regimen to stick to than daily pills, according to Mitchell Warren, executive director of AVAC, an HIV prevention advocacy organization.

“If you can take a pill every day, that’s great. But if you can’t, we see a lot of people who start [taking the pills] who don’t continue,” he said.

Aside from the inconvenience, there can be a stigma attached to taking the pills, Warren said. The drugs for prevention, called pre-exposure prophylaxis, or PrEP, are the same as the drugs used to treat HIV infection.

“If you’re a young person and your parents find your pill bottle, they say, ‘Why are you taking this pill? Are you HIV infected?’ And the young person may say, ‘No, I’m protecting myself,'” Warren said. “And they say, ‘Well, why are you having sex?'”

Long-lasting drugs like cabotegravir or another new product, a once-a-month vaginal ring, offer patients more choices, he added.

About 1.5 million people were newly infected with HIV in 2021, according to the World Health Organization, about 60% of them in Africa.

Uganda and Zimbabwe approved cabotegravir for PrEP earlier this year. They are the first countries in sub-Saharan Africa to do so.

These approvals come less than a year after the U.S. Food and Drug Administration authorized it.

That’s progress, Warren said. FDA approved PrEP pills in 2012, but “it took three years before any African regulatory agency approved it. So, we’ve already seen a condensing of that timeline.”

Cabotegravir costs $22,000 per year in the United States. ViiV Healthcare, the company that makes the drug, has not officially announced what it will cost in low- and middle-income countries, but it is expected to be much lower. Some aid groups have indicated that ViiV will offer the drug at $250 per year.

“The problem is that actually that won’t be really affordable for countries who need to roll it out and scale up,” said Jessica Burry, a pharmacist with humanitarian group Doctors without Borders.

PrEP pills cost about $54 per year, Warren said.

“The hope is that early in 2023, we can see a price point that is much closer to that 54 [dollars] than to the 250 [dollars],” he said. “Hopefully, in the $100 range per year.”

ViiV said it is working with the U.N.-backed Medicines Patent Pool to allow generic manufacturers to produce cabotegravir at a lower price for low- and middle-income countries.

ViiV said cabotegravir is more complicated to manufacture than most HIV drugs. No generic manufacturers have been selected yet. Once they are, it will take about three to five years before a generic version is on the market.

The company has filed for regulatory approval in 11 countries so far. Burry says there should be more.

“If they’re going to be the only supplier for the next four or five years until generics are available, then they really need to step up to the plate and actually file, register and get that drug available,” she said.

Demand for the drug is unclear. PrEP pills have been slow to catch on.

About 845,000 people in more than 50 countries took them in 2020, but the United Nations was aiming for 3 million by that time.

“We don’t have a ton of PrEP users, so if you’re ViiV, you’re looking at a very small market,” Warren said.

Warren said providers and advocates need to help grow that market. They need to do a better job connecting people at risk with programs that offer PrEP, he added.

“Some of the early PrEP programs began with us thinking that if you just bought the product, people would magically show up,” he said.

Warren hopes to change that as part of a coalition that includes ViiV, the Bill and Melinda Gates Foundation, the World Health Organization and others.

“There’s a huge effort in this coalition to bring in civil society from day one, and the communities that this product is meant to help and support,” he said.

The slow uptake means PrEP has not yet shown that it can make much of a real-world impact, Warren noted. He hopes to see research programs launch next year to find the best ways to reach the communities most at risk and lower infection rates.

“If we can’t show that in the next three years, then we don’t necessarily need all these generic manufacturers, because there will not be a market for this product,” he said.

Source: Voice of America

UN Puts Baguette on Cultural Heritage List

The humble baguette — the crunchy ambassador for French baking around the world — is being added to the U.N.’s list of intangible cultural heritage as a cherished tradition to be preserved by humanity.

UNESCO experts gathering in Morocco this week decided that the simple French flute — made only of flour, water, salt, and yeast — deserved U.N. recognition, after France’s culture ministry warned of a “continuous decline” in the number of traditional bakeries, with some 400 closing every year over the past half-century.

The U.N. cultural agency’s chief, Audrey Azoulay, said the decision honors more than just bread; it recognizes the “savoir-faire of artisanal bakers” and “a daily ritual.”

“It is important that these craft knowledge and social practices can continue to exist in the future,” added Azoulay, a former French culture minister.

With the bread’s new status, the French government said it planned to create an artisanal baguette day, called the “Open Bakehouse Day,” to connect the French better with their heritage.

Back in France, bakers seemed proud, if unsurprised.

“Of course, it should be on the list because the baguette symbolizes the world. It’s universal,” said Asma Farhat, baker at Julien’s Bakery near Paris’ Champs-Elysee avenue.

“If there’s no baguette, you cant have a proper meal. In the morning you can toast it, for lunch it’s a sandwich, and then it accompanies dinner.”

Despite the decline in traditional bakery numbers, France’s 67 million people still remain voracious baguette consumers — purchased at a variety sales points, including in supermarkets. The problem is, observers say, that they can often be poor in quality.

“It’s very easy to get bad baguette in France. It’s the traditional baguette from the traditional bakery that’s in danger. It’s about quality not quantity,” said one Paris resident, Marine Fourchier, 52.

In January, French supermarket chain Leclerc was criticized by traditional bakers and farmers for its much publicized 29-cent baguette, accused of sacrificing the quality of the famed 65-centimeter (26-inch) loaf. A baguette normally costs just over 90 euro cents (just over $1), seen by some as an index on the health of the French economy.

The baguette is serious business. France’s “Bread Observatory” — a venerable institution that closely follows the fortunes of the flute — notes that the French munch through 320 baguettes of one form or another every second. That’s an average of half a baguette per person per day, and 10 billion every year.

Although it seems like the quintessential French product, the baguette was said to have been invented by Vienna-born baker August Zang in 1839. Zang put in place France’s steam oven, making it possible to produce bread with a brittle crust yet fluffy interior.

The product’s zenith did not come until the 1920s, with the advent of a French law preventing bakers from working before 4 a.m. The baguette’s long, thin shape meant it could be made more quickly than its stodgy cousins, so it was the only bread that bakers could make in time for breakfast.

The “artisanal know-how and culture of baguette bread” was inscribed at the Morocco meeting among other global cultural heritage items, including Japan’s Furyu-odori ritual dances, and Cuba’s light rum masters.

Source: Voice of America