Monthly Injectable HIV med on the way
ViiV Healthcare submitted a New Drug Application (NDA) to the FDA for a monthly injectable HIV medication. Two shots in the butt muscles—one injection of cabotegravir and one of rilpivirine. That’s it.
Rilpivirine is already available in tablet form (under the brand name Edurant). The new injectables are long-acting versions, so it’s called long-acting cabotegravir and rilpivirine (CAB LA/RPV LA).
The NDA was submitted April 29. Learn more at positivelyaware.com/drug-guides/long-acting-cabotegravirrilpivirine.
Activists sue AIDS pharma
Declaring that pharmaceutical companies work together to keep the cost of HIV medications high, lawyers filed an antitrust lawsuit against them in federal court in San Francisco on behalf of AIDS activists. Peter Staley et al. vs. Gilead Sciences et al. states that “the manufacturers used anticompetitive tactics to keep prices high on some of the most important and widely used medicines for the treatment and prevention of the HIV virus, including Truvada, Descovy, Atripla, Genvoya, and Odefsey,” among other antiviral drugs. The lawsuit also declares that the companies agreed among themselves not to use cheaper generic versions of their medications in combining them for fixed-dose combinations.
Lead plaintiff and renowned AIDS activist Peter Staley said, “ACT UP successfully fought for a dramatically lower price on AZT, the first AIDS drug, resulting in far lower prices on the next 10 drugs that came to market. Now Gilead and its co-conspirators have turned back the clock to monopolistic practices and pricing. We will not let this stand.”
PARTNER2 and undetectable virus
The PARTNER2 study showing that undetectable viral load in gay men means that they are unable to transmit HIV to their sex partners was published May 2 in the leading medical journal The Lancet.
“Our results provide a similar level of evidence on viral suppression and HIV transmission risk for gay men to that previously generated for heterosexual couples and suggest that the risk of HIV transmission in gay couples through condomless sex when HIV viral load is suppressed is effectively zero,” the research team reported. “Our findings support the message of the U=U (undetectable equals untransmittable) campaign, and the benefits of early testing and treatment for HIV.”
Results were based on 972 gay male couples.
Although the findings were first reported several years ago, publication in a medical journal is given greater weight because of the vigorous review process undergone before publication.
Read the study free online at thelancet.com/journals/lancet/article/PIIS0140-6736(19)30418-0/fulltext.
Ian Green, CEO of the Terrence Higgins Trust, the largest non-profit HIV organization in the UK, wrote an opinion piece on the effect that these findings have on stigma, “Stop doubting the evidence—people living with HIV and on effective treatment cannot pass it on.” Read it at news.trust.org/item/20190508111736-cdfe3.
Gilead donates Truvada for PrEP
Gilead Sciences, maker of Truvada for PrEP (HIV prevention), announced that it would donate the medication to the Centers for Disease Control and Prevention (CDC) to support the agency’s national efforts to protect people against the virus. The company said it would provide the CDC with up to 2.4 million bottles a year up to 2030, destined for uninsured individuals. Gilead reported that “This medication donation is among the largest ever in the United States and is part of Gilead’s broader ongoing initiatives to help ensure that everyone who can benefit from PrEP is able to access it.”
As usual, it was good news/bad news for activists. On the one hand there was gratitude for help in fighting the epidemic. On the other hand, there was pointing to the problems that continue. Among other things, Gilead reached an agreement to make generic Truvada available next year. (Go to breakthepatent.org for more on that.) Descovy, on the other hand, is far from becoming available as a generic. It’s also set to be FDA approved for HIV prevention this year.
Editorials in The New York Times discussed several problems with the donations, stating that Truvada was created with taxpayer dollars and that the donation—a tax writeoff—will probably benefit the company’s stockholders more than the people receiving the donations. One editorial was titled “Gilead’s Gift Horse.”
Australian man talks about his HIV while on PrEP
After years of being a public face for PrEP, Australian Steve Spencer recently acquired HIV. He was then open about his new status, starting at the 41st Sydney Gay and Lesbian Mardi Gras Parade in March. “This has turned a process of grief and anguish into an event of celebration—a celebration of my health, a celebration of my community, and a celebration of remaining true to myself,” Spencer told writer Nic Holas in an interview. Read “‘I am Prepared’: Steve Spencer on Becoming HIV Positive in the Era of PrEP and U=U” at starobserver.com.au/news/national-news/i-am-prepared-steve-spencer-on-becoming-hiv-positive-in-the-era-of-prep-and-uu/179646.
Dr. Demetre Daskalakis, Deputy Commissioner for the Division of Disease Control in New York City’s Department of Health and Mental Hygiene, discusses the 2-1-1 method of PrEP Spencer used, at out.com/health/2019/3/22/what-you-need-know-about-prep-demand. “This is an effective strategy, Dr. Daskalakis explains.
Ban ends UCSF’s fetal tissue HIV cure research
The White House announced that the U.S. Department of Health and Human Services would ban the use of fetal tissue in any federally funded medical research. The June 5 announcement immediately halted HIV cure research that used fetal tissue at the University of California-San Francisco.
“Today’s action ends a 30-year partnership with the [National Institutes of Health] to use specially designed models that could be developed only through the use of fetal tissue to find a cure for HIV,” said the university’s chancellor, Sam Hawgood, MBBS. “We believe this decision to be politically motivated, shortsighted and not based on sound science.”
Fetal tissue collected from elective abortions has been instrumental in work on such diseases as HIV, cancer, and Zika.
According to a Washington Post report, an anonymous White House official said that Vice President Mike Pence, who strongly opposes abortion, worked closely with HHS to develop the policy.
Read the HHS statement: hhs.gov/about/news/2019/06/05/statement-from-the-department-of-health-and-human-services.html.
—Rick Guasco, from reports in the Washington Post and the San Francisco Chronicle
Tenofovir class action lawsuits
Law firms have been advertising a class action lawsuit against the makers of the HIV medication tenofovir DF (brand name Viread, also found in Atripla, Complera, Stribild, and Truvada). What should you know about joining such a suit as a plaintiff?
I reached out to Eric K. Farmer, PharmD, who worked on the 2019 POSITIVELY AWARE HIV Drug Guide. He checked with Katherine Wood, MLP Attorney for Indiana University Health Methodist and University Hospitals, where Dr. Farmer practices.
“Class action lawsuits aren’t likely to get individual class members much money, unless they suffered serious injuries and become named plaintiffs in the case,” Wood said. “Class actions generally are not about making individual class members rich, and getting compensation is often much harder than getting judgments that force people to stop engaging in an illegal activity. Patients who have had serious injuries may get compensated more fairly (kidney failure or severe bone density loss), but it’s not guaranteed or even more likely than not. But really, the lawyers are the ones who will get compensated fairly for their time working on the case, and the class members will get compensated partially (and possibly insignificantly) for their actual injuries.”
I also reached out to the Legal Council for Health Justice in Chicago. The council provided the following:
Are my injuries serious enough to have a good case? Each law firm is going to have their own opinion on how severe injuries must be to have a strong case.
A case can take a long time to settle. Even if a claim is settled before trial, it could still take years before plaintiffs see any award. Going to trial or additional appeals can further delay resolution.
If you want to file your own claim, you will need to find a law firm willing to represent you as an individual. You will need to have a strong claim, serious injuries, and be willing to participate in litigation.
By contrast, in a class action a group of people with the same or similar injuries caused by the same product or action sue the defendant as a group. Your participation in a class action may be very minimal unless you are a named plaintiff. Named plaintiffs are representatives of the class and are named in the lawsuit. They participate more in the case and can get a larger portion of any award.
Law firms representing consumers usually get paid by taking a percentage of the final award. If their clients lose the case, they do not get paid. If their clients win, it is common for a law firm to take around 40%.
It can be exciting to hear about cases with multi-million dollar settlements. However, even if a class action is settled for a large amount of money, class members may only end up with a small portion. How much each person gets depends on many things, but a big factor is how many people are in the class.
Imagine a class action is settled for $5 million and there are 5,000 class members. First, the law firm will take their fee and additional funds to cover court costs. If the law firm takes 40%, that leaves less than $2 million to be divided among the plaintiffs. Even if named plaintiffs and class members receive an equal amount of the settlement, they would each get $400.
This is not to discourage participation in class actions, but it is important to manage your expectations.
Here are a few things to think about when searching for a lawyer to represent you:
Consider talking to more than one law firm before you sign any agreement. It’s better to understand your options.
How well will the law firm communicate with you? Do they clearly explain the process and how long it may take? Will you have a point person you can contact? Will they provide you regular updates?
What will it cost you? What will they charge you for their services? Can they provide a clear list of costs? For example, will you have to pay for experts, medical consultation, and court costs?
SPECIAL THANKS to Jessica Rhoades, staff attorney at the Legal Council for Health Justice, for putting together this information.