Generic Truvada now available in U.S.
Enid Vázquez @ENIDVAZQUEZPA

A generic version of the medication Truvada, which is used for both HIV treatment and PrEP, is now—finally—available in the U.S. The generic medication from Teva Pharmaceuticals USA was actually approved by the U.S. Food and Drug Administration (FDA) in 2017, but the Gilead Sciences patent on Truvada prevented its availability as a generic.

Then Gilead announced it was relinquishing its Truvada patent a year early, in 2020. Gilead made an agreement with Teva, allowing the generic version of tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC) to be made commercially available this year. Teva reported that the generic Truvada tablets “are expected to be available through retailers and wholesalers at a Wholesale Acquisition Cost (WAC) of $48.51.”

A bottle of 30 tablets (a month’s supply) would be $1,455.30. This compares to $1,755.30 for the wholesale acquisition cost for Truvada and the average wholesale price (AWP) for Truvada of $2,210.74 per month, according to Eric Farmer, PharmD, at Indiana University Health LifeCare Clinic, and pharmacist for the Positively Aware HIV Drug Guide. Different clinics and hospital systems negotiate with pharmaceuticals based on the WAC and AWP prices. Patients will not pay those prices, unless paying entirely out-of-pocket (in the absence of insurance or other financial assistance). “The price won’t change too much until other generic manufacturers or formulations become available to increase competition in the market,” said Dr. Farmer.

According to Teva’s announcement, “Actual costs to individual patients and providers are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program.”Teva also made available a generic form of Atripla, but that single-tablet regimen is no longer recommended for first-time HIV therapy. The Teva wholesale acquisition cost is $78.86 per tablet, or $2,365.80 for a bottle of 30. Atripla’s AWP, according to the PA drug guide, is $3,583.65/month.

Go to TevaHIVgenerics.com. Our HIV Drug Guide is at positivelyaware.com/hiv-drug-guide.

Pricing for generic Truvada and Atripla

There’s more than one way to skin a price cut. For the new generic of Truvada, the devil may be in the co-pay. In a message to fellow pharmacy staff at the pharmacies of Indiana University Health, Matthew Reed, CPhT, laid out some reasons why going generic may end up costing more.

“Truvada and Atripla’s current copay card (from Gilead) does not have a monthly cap on the amount of assistance (there is an annual cap of $7,200 and $6,000 respectively),” wrote Reed, a certified pharmacy technician and Patient Care Coordinator. “A patient with a high deductible plan will typically have a cost of about $1,600 and $2,400 per month when their plan resets until the deductible is met. With no monthly cap on assistance, the patient is typically able to continue therapy without any out-of-pocket expense.”

“The new generics being released,” Reed continued, “also have copay assistance programs setup for patients, but the programs have a monthly cap. The copay card for generic Truvada will pay a maximum of $600 per month. The copay card for generic Atripla will pay a maximum of $750 per month. Since the generic versions are similarly priced to the brand, a patient with a high deductible plan may have an out-of-pocket expense greater than $800 per month until their deductible is met even after the copay assistance card. In today’s insurance environment, these programs may be viewed as grossly insufficient for keeping a patient on therapy. It can be especially difficult for a patient that always had a $0 copay to be told they must suddenly pay a much larger copay for a generic version. Unfortunately, patients often do not learn of this change until requesting a refill giving them little time to financially plan for such a large change.”

“In talking about generic releases of brand specialty medications, cost and copay assistance offered is a major concern,” Reed said. “This is a great example of how a change to generic may cost the patient with commercial insurance much more than what they paid for the brand name.”

Generic Truvada cost sharing

A reminder: the U.S. Preventative Services Task Force (USPSTF) made a recommendation in June 2019 limiting a patient’s cost-sharing expense for PrEP that is slated to start in 2021. Private insurance plans that are not grandfathered in must cover PrEP without cost-sharing payments, such as co-pays, from patients. Health Affairs has more information: healthaffairs.org/do/10.1377/hblog20190613.596797/full.

Dovato shows promise for rapid start

 

“Rapid start” HIV therapy has become the standard of care. Also called “test and treat,” it means putting people on HIV treatment within two weeks after diagnosis. But for rapid start, not all HIV drugs are equal. A recently reported study showed that the HIV medication Dovato (dolutegravir/lamivudine) may be effective for rapid initiation.

Individuals were put on Dovato within 14 days of their diagnosis, and before test results for hepatitis B, renal function, and drug resistance were back. All people who are newly diagnosed should be tested for hepatitis B and C. They should also know their hep B status before starting some HIV drugs that can also treat hepatitis B, as lamivudine does. Otherwise, they may experience a flare-up of their hep B when stopping or switching their HIV treatment.

The STAT study found that for the five individuals who had hepatitis B at baseline, all had undetectable viral load (less than 50) at the six-month mark. They had been successfully switched to other HIV therapy. HIV treatment needs to include two medications that work against hepatitis B for those who are co-infected with HBV and HIV.

For the participants in the clinical trial with available data, 92% (102) had undetectable viral load. ViiV Healthcare reported its findings at ACTHIV 2020 (the American Conference for the Treatment of HIV), held virtually in August. The study is continuing out to 48 weeks.

New cure potential

A research group looking into HIV cure reported a new way that it may happen.

Cure research has long looked at elite controllers, people living with HIV who continue to have undetectable viral load without treatment. Cure research also looks at the HIV reservoir, places in the body where the virus hides. Once HIV treatment dominates the virus, HIV may lie dormant in these sites ready to continue battling against the body. Ready to rumble, so to speak.

Now, a group reports new information on reservoir sites. Elite controllers appear to have HIV in areas of these sites different from people who have controlled the virus long-term using medication. The team said this different configuration points to the importance of the quality of reservoir sites, not just the quantity of the virus there.

Understanding how HIV functions in elite controllers raises hopes of helping to control the virus in others.

Chenyang Jiang, of the Raygon Institute of Massachusetts General Hospital, MIT, and Harvard, and colleagues published their study in the August 26 issue of Nature, but their highly technical report was told in a more accessible story format the same day by The New York Times. Read “A Woman May Have Been Cured of H.I.V. without Medical Treatment” at nytimes.com/2020/08/26/health/hiv-cure.html.

Islatravir continues to show promise

Merck & Co. reported that 96-week results of its investigational drug islatravir are “consistent” with promising data seen at 48 weeks. Islatravir belongs to a new HIV drug class that has not yet hit the market: nucleoside reverse transcriptase translocation inhibitors (NRTTIs). The company also reported good early results for a new once-a-week oral HIV compound.

Islatravir was given with doravirine, a drug that is already available under the brand name Pifeltro. The two meds were given at the same time as a once-daily regimen. For the first 24 weeks, study participants also took 3TC (brand name Epivir) before the regimen was simplified from three drugs to two.

The islatravir regimen was compared to Delstrigo, a single-tablet regimen containing doravirine plus lamivudine and tenofovir DF.

All participants were taking HIV medication for the first time (treatment-naïve). 

Islatravir will move forward in research at a 0.75 mg dose for the 90 participants taking it. The three islatravir groups had an average of 81.1% of participants who had an undetectable viral load (fewer than 50 copies). This compared to 80.6% for the 31 individuals taking Delstrigo. The average for the islatravir groups was dragged down by the discontinuation rate among those receiving the highest test dose, 2.25 mg.

A new oral HIV compound, MK-8507, is moving forward into Phase 2 study in combination with islatravir. The two-drug regimen will be taken once weekly. MK-8507 is a non-nucleoside reverse transcriptase inhibitor (NNRTI).

The drug studies were presented as oral and poster presentations at the virtual 2020 International Congress on Drug Therapy in HIV Infection, in Glasgow (HIV Glasgow 2020) in October.

U=U: Spread the word

“For ART [antiretroviral therapy], the science is strong and clear; the data show that the effectiveness of ART with viral suppression is estimated to be 100% for preventing sexual transmission of HIV. In other words, for persons taking ART as prescribed and achieving and maintaining viral suppression, there is effectively no risk of transmitting HIV through sex.” So wrote Eugene McCray, MD, director of the Division of HIV/AIDS Prevention of the National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention, at the Centers for Disease Control and Prevention (CDC). Dr. McCray reached out to health departments and community organizations in a July letter, after CDC updated its web page on “Effectiveness of Prevention Strategies to Reduce the Risk of Acquiring or Transmitting HIV.” The page is full of research information, walking you through the scientific evidence. “I am writing to encourage you to continue your work to spread the word about the power of viral suppression to improve the health of people with HIV and to prevent the sexual transmission of HIV,” Dr. McCray wrote. “This information is important and has the power to change lives.” Go to bit.ly/EffectivenessofPreventionStrategies.

PrEP on vacation

How’s this for the innovative use of PrEP? Give people the HIV prevention pill before they go on vacation. Although one pill a day keeps the HIV away, that’s not always so easy to do. So, a group of researchers put 54 men who have sex with men (MSM) on the prevention pill before the guys went on vacation. Of these, 48 completed a three-month visit afterward. Three-quarters of the men reported having condomless sex during the vacation—something they had done previously—and a third reported having recreational drug use. The research team called the strategy “Epi-PrEP,” for episodic use. The majority of the men, however, continued to use PrEP after their vacation—and 94% of them had prevention drug levels consistent with daily use. “Many participants felt the experience of initiating PrEP while on vacation could be a means for transition to long-term PrEP use,” the team noted in its conclusions. One of the men acquired HIV after stopping PrEP following his vacation. James E. Egan, MPH, Ph.D., and colleagues published their findings in the August 15 issue of JAIDS.

My Fabulous Disease wins GLAAD award

Blogger Mark S. King received the 2020 GLAAD Media Award for Outstanding Blog for My Fabulous Disease. The blog’s introduction: “I’m an HIV-positive gay man in recovery from drug addiction. What’s not to love?”

“I accept this honor with great humility and a lot of sashaying around my living room,” King wrote. “Meaning more sashaying than usual.

“I have been living with HIV for more than 35 years. Long-term survivors are the wounded elders of our tribe. We are the storytellers of an epic tale of courage and humanity. I am so gratified to know that GLAAD has been listening,” King posted on July 30, the day of the awards.

King also received the LGBT Journalist of the Year 2020 award from the Association of LGBTQ Journalists (NLGJA). The association also recognized him with the Excellence in Blogging Award for 2014, 2017, and again this year.

GLAAD was founded in 1985 in response to inflammatory coverage of HIV and AIDS.

Damn you, COVID-19, for making the fabulous Mark S. King’s moment virtual. How great the tall, handsome redhead would have looked sashaying in the aisles.

Gilead privacy lawsuit

“An Alabama man was mortified when an envelope for him with the return address HIV Prevention Team in bold red lettering turned up in his workplace mailroom,” reported the newsletter of the AIDS Law Project of Pennsylvania. “An Indiana man, who is so protective of his confidentiality that he fills his HIV-related prescriptions at a different pharmacy chain from where he gets his other medications, was shocked to receive the same mailing.”

As a result of the incidents, the two men are being represented by the law project and the law firms of Berger Montague PC and Langer Grogan & Diver PC in a class action lawsuit against Gilead, the sender of the envelopes.

The two men had signed up for the company’s Advancing Access Program, which offers discounts for Gilead’s PrEP medications. It appears that the envelopes were meant for providers, not people in the program.

Opioid agonists in lock-up during COVID

A survey of opioid agonist treatment (OAT) programs for incarcerated individuals found that half had challenges maintaining their staff under the COVID-19 crisis. On the other hand, most—more than 80%—saw early release given to OAT participants.

A research team from Johns Hopkins University used an online survey in May of 19 institutions that were providing maintenance treatment with methadone or buprenorphine around the time COVID-19 hit the U.S. Sixteen (84%) responded: 12 jails and four prisons.

A report on the survey results in the Addiction Treatment Forum called the downsizing “a matter of concern, because OAT is known to reduce mortality and improve treatment outcomes.” The article quoted the study team itself as noting that, “By threatening access to life-saving medications, the COVID-19 pandemic poses an additional threat to an already vulnerable and highly marginalized population.” The team also noted that jails and prisons are “at the epicenter of the [COVID-19] pandemic in the United States.”

The study by Sachini Bandara, Ph.D., and colleagues was published online August 27 ahead of print in the Journal of Addiction Medicine. Read the Addiction Treatment Forum report at atforum.com/2020/09/covid-19-threatens-incarcerated-loss-oat-treatment. See also “Five Ways the Criminal Justice System Could Slow the Pandemic” from the Prison Policy Initiative at prisonpolicy.org/blog/2020/03/27/slowpandemic.

Mental health and substance use

“People with substance use disorders often have long histories of unmitigated mental illness and trauma. With very little access to the same treatment and support than their white counterparts, Black and brown people with substance use disorders are especially vulnerable to cycling in and out of correctional facilities and emergency rooms,” reported the Latino Commission on AIDS as the agency presented a webinar, “Mental Health and Substance Use: Realities and Challenges During Uncertain Times,” June 11 on its YouTube channel. The presentation includes an overview of challenges seen by the Substance Abuse and Mental Health Services Administration (SAMHSA), and a presentation from the Harm Reduction Coalition. Go to bit.ly/LatinoAIDSwebinar2020-06-11.

National Latinx AIDS Awareness Day

“Ending HIV is at your fingertips” was the theme of this year’s National Latinx AIDS Awareness Day. The theme “focuses on the tools already available to address the HIV pandemic as we are dealing with another one,” organizers reported. “While we continue maintaining social distance and following preventive measures to respond to the COVID-19 pandemic, we ask everyone to do their part in the fight against HIV: take the HIV test, learn about HIV and risk factors, consider using PrEP and condoms as prevention approaches, and stay adherent to HIV treatment to become virally suppressed or undetectable.… We see the impact of stigma, homophobia, transphobia, and xenophobia as major barriers in accessing HIV testing, prevention, treatment, and care in our community.” In 2018, more than one in four new HIV diagnoses (27%) occurred in Latinx, although they represent only 18% of the national population. Go to nlaad.org.

AIDS.gov is now HIV.gov

“The U.S. Department of Health and Human Services [HHS] today officially changed the name of AIDS.gov, the federal government’s leading source for information about HIV, to HIV.gov,” the agency reported June 5. “The announcement coincides with the 36th anniversary of the Centers for Disease Control and Prevention’s first report of the initial cases of what would become known as AIDS. The name change reflects major scientific advances that have transformed an almost universally fatal disease to a condition that, if diagnosed and treated early and continuously, can be controlled and prevented from progressing to AIDS. In fact, there are more people living with HIV in the United States now than people living with AIDS.” Go to hhs.gov/about/news/2017/06/05/more-name-change-aidsgov-becomes-hivgov.html to read the announcement.

Samus Starbody and Zeus

‘When Dogs Heal’

Healing takes more than medicine. Sometimes it takes love. Read true tales of exquisite connection in the new book, When Dogs Heal: Powerful Stories of People Living with HIV and the Dogs That Saved Them. A portion of the proceeds goes to Fred Says, a Chicago-based organization that raises money for teens living with HIV. Due out early next year, look for pre-sales of the book on World AIDS Day (December 1) at whendogsheal.org.

Paul Stalbaum (above, in white t-shirt)

‘Poz Cruise’ founder Paul Stalbaum dies

Paul Stalbaum, the travel agency owner who founded a yearly cruise voyage specifically for people living with HIV, died in August after years of struggling with cancer.

The HIV Cruise Retreat, better known as “The Poz Cruise,” provided education and entertainment, but more importantly, the chance to create community with people around the country. Paul negotiated the best prices he could for the cruise and also made sure that scholarships were available to help people attend it.

Paul has a special place in my heart for being one of the few people to reach out to Briefly, wanting to let people all over the country hear about the cruise. I never met Paul, but he was just loving in all his communications and wanted to make the world a better place. Happy heavenly travels, Paul.

Lark Lands (courtesy Bob Lederer)

Remembering Lark Lands

Lark Lands, who wrote about alternative therapies for people with HIV/AIDS, died of cancer on November 2019, but was remembered by her friends and colleagues in the community with an online memorial celebration of her life on her birthday, September 5. Over the decades, many attributed their survival directly to her advice and counsel. She wrote regularly for POZ magazine for many years, and served as its science editor, and her work also appeared in Positively Aware.

Lark had Type I diabetes, also known as “childhood diabetes.” Her parents were told she would die by age 12. She laughed at having beaten that prediction. But her serious condition left her with a strong drive to learn about metabolic processes and anything that could help her survive and be healthy. Then AIDS came along and she turned her knowledge and skills to helping the HIV community. At the time, there were no medications. Lark spoke with individuals and at community meetings about the things that could be done to ease symptoms of disease and strengthen the body. Although she devoted her life work to the HIV community, she rarely received compensation. Later, when HIV medications became available, she turned her attention to dealing with the side effects of treatment as well. Later in life, she founded a project in South Africa to help orphans and impoverished families. Lark continued to tend to her health and once told me that she could swallow a handful of supplements with one glass of water. Her vitality was unbelievable.

“For decades my friend Lark Lands was the person I called with every question and fear I had about my HIV/AIDS diagnosis. … Any time, day or night her phone rang from longtime friends with HIV or a complete stranger who had been given her number,” said Gregg Cassin, said Gregg Cassin of Shanti Project in San Francisco, and co-founder of AIDS, Medicine, and Miracles.

Rest in power, Lark Lands.