There Just May Be Balm in Gilead: A New HIV Medication. The U.S. FDA Approves a New "One-a-Day" Medication for HIV

Communicable Diseases 927 views
Written by Scott Berry

The "hotly anticipated" new one-a-day tablet to treat HIV has been approved, albeit with a "black-box warning" for people with Hepatitis B, and at a steep, if competitive price.

There Just May Be Balm in Gilead: A New HIV Medication. The U.S. FDA Approves a New "One-a-Day" Medication for HIV

Sadly, the evidence is that HIV is here to stay. It now seems as old as Moses in Egypt that President Obama went to the mountain and not only envisioned a "World without AIDS" but made a pledge to move in that direction. His successor’s “We’ll be saying Merry Christmas again” celebrated the holiday by FedExing, on the Eve, notices to the remaining members of the White House AIDS Panel—the ones who had not already quit—that their agency was dissolved and their jobs terminated.

Trump can no more be blamed for the persistence of AIDS anymore than can the regimens of drugs that have made it a chronic condition that can be managed and lived with. Even so, the increasingly prevailing mindset and skill-honed corruption that masquerade as “policies” worldwide do drive the inequality that make the drugs agents of what could be called selective genocide.

And statistics gathered in the more prosperous world suggest that the selective availability of effective treatment protocols have, for too many, made the cost-effective condom universally deplored by its onetime or would-be wearers all but obsolete in risk communities once again.

To see those vectors intersect, look no farther than the American insurance companies, which have been more emboldened than imperiled by government, currently militating against coverage of PrEP (pre-exposure prophylaxis) drugs.

The issue, in short, has not gotten simpler. And while the cultural message seems to be asserting itself anew—films, like the new French BPM, about AIDS-activism in France in the ‘80s and ‘90s, and a raft of books, fiction and non-, about the crisis we nearly didn’t scrape through—are back in something like force.

Triumphalism is not. The question has once again become “Who do you have to fuck to get tickets to Angels in America?”—the tow-part play an anthem now scrupulously updated by its author. It comes with London West End and New York Broadway star-studded casts and ticket prices that cannily reflect inflation since the days of AZT.

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Any good news?

Perhaps fearing its own imminent demise in newly “anti-science” Washington, a week before Valentine’s Day (Yanks of a certain age will recall when it was called “VD Day” with the hehe of a more naïve era), the U.S. federal Food and Drug Administration approved a new drug, Biktarvy.

The word on the line is that it is a good thing. What’s for sure is that it does not address inequality issues. Perhaps inadvertently, the drugmaker has called it “a drug for Americans,” a “group” that, as a whole, is less than confident about future health coverage in general.

Convenience as a major step forward in effective treatment

“We’ve come a long way,” Dr. David Wohl of the University of North Carolina told Liz Highleyman, a reporter for the San Francisco Bay Area Reporter, the oldest continuously published LGBT newspaper in the U.S., for an article headlined “FDA approves new HIV combo pill.”

Calling it “another new HIV med with a vowel-packed name” (though we count more consonants than vowels even if you allow for the “y”), he added that it was “a big deal. In one small pill we have three of the best antiretrovirals ever made. Almost anyone starting HIV therapy and many on older regimens can take Biktarvy.”

Developed by the Bay Area firm Gilead Sciences, “once-a-day” Biktarvy has so far shown few side effects and has been approved for adults starting HIV treatment “for the first time” and people already on treatment with an undetectable viral load. It is a single-tablet regimen that contains bictegravir, which has received approval for the first time because in the new formula, it does not require simultaneously taking an additional phramocoenhancer, or “booster.”

Preliminary reports were made at the International AIDS Conference in Paris last year. The article in the B.A.R. provides a further, more technical, history of the new drug’s progress through testing.

“In October,” Highleyman added, “Gilead announced data from a third study showing that people who switched from a boosted HIV protease inhibitor to Biktarvy were as likely to maintain an undetectable viral load as those who stayed on their existing regimen—again around 90 percent.

“Results from the fourth study are expected to be presented at an upcoming HIV conference. Biktarvy is currently being further tested in a women-only trial and in a study of children and adolescents, according to Gilead.”

Cost and other downsides

The wholesale price Gilead has set for Biktarvy—$36,000 per year—is, Highleyman noted, “in the same range as competing options.” Gilead has already been sued by a company called ViiV Healthcare, for patent infringements on one of its drugs, dolutegravir, used in its integrase inhibitor combination Triumeq. Gilead denies the allegation.

Although Gilead does recommend careful monitoring of kidney enzymes for people on Biktarvy, the following is the conclusion of an article issued by Project Inform (verbatim):

“The most common reactions in those who took Biktarvy were headache, nausea and diarrhea. Both regimens were safe and well tolerated and no serious side effects were seen. Similar rates of side effects were seen between groups in all studies. Lab abnormalities were also similar between all groups (occurring in <10% of participants) as well as measures of liver and kidney health.

“Biktarvy has not been reviewed by the DHHS HIV Treatment Guidelines Committee, so it’s unknown where it will be placed on the list of recommended regimens.”

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So far, the reception is generally pos

An article in the journal POZ, “FDA Approves Gilead’s Single-Tablet HIV Regimen Biktarvy,” author Benjamin Ryan notes, as do his counterparts in csimilar journals, that Bitarvy is also the “the smallest integrase-inhibitor-based single-tablet antiretroviral (ARV) regimen on the market today.” In the seemingly endless battle with HIV, size has long since stopped being a consideration. Still, who would mind a smaller pill?

But worth noting is another paragraph in Ryan’s article:

“Gilead’s new regimen has received a black box warning, the FDA’s highest level of caution, regarding the potential for those who have both HIV and hepatitis B virus (HBV) to experience severe acute exacerbations of hep B after going off Biktarvy. Clinicians should closely monitor the liver function of people with HIV and HBV after they discontinue Biktarvy, maintaining this watchful eye for at least several months. According to Gilead, ‘If appropriate, anti–hepatitis B therapy may be warranted.’”

POZ is nevertheless not shy of calling Biktarvy the “hotly anticipated single-tablet combination HIV treatment regimen.” Indeed, the heat is on.

Sources/Reading: (company press release) (“Highlights of prescribing information”) (mostly about the ViiV lawsuit)