What’s the deal?

Recently, a multimedia advertising campaign promoting lawsuits for safety issues related to Truvada (TDF/FTC) has been launched. These advertisements are looking for people living with HIV (PLWH) who are taking or have taken Truvada along with those taking Truvada as pre-exposure prophylaxis (PrEP) to join a lawsuit against Gilead Sciences, the company that makes Truvada. The ads are searching for people who have had or feel that they have had serious side effects related to taking Truvada (TDF/FTC).

Both the HIV Medicine Association (HIVMA) and the American Academy of HIV Medicine (AAHIVM), which together represent the great majority of HIV medical care providers in the United States, are increasingly receiving reports of patients coming into their clinics with concerns about taking Truvada either for PrEP or HIV treatment due to this campaign. 

While medical care providers discuss the benefits and risks of all antiretroviral drugs used for treatment and prevention of HIV during clinic visits, we are concerned about persons with newly diagnosed HIV and potential PrEP users who do not have a medical provider. Some may be scared off by these ads or may delay accessing HIV treatment or PrEP. Some PLWH may stop taking their HIV medications without discussing all options with their HIV provider because of these misleading ads about Truvada.   

Why is this happening now?

While we do not know for sure why these ads are appearing now, the timing of the lawsuits and ad campaign coincides with planning for the largest scale-up of PrEP and HIV treatment access in U.S. history to begin in 2020 as part of the U.S. government’s “Ending the HIV Epidemic” (EtE) Initiative.  

This ad campaign potentially threatens the Initiative’s success particularly in the South and Southeast United States where mistrust of the health care system can be higher and barriers to accessible health care greater.

Interestingly, the negative ad campaign is also occurring just as a new, more expensive option for PrEP, Descovy (TAF/FTC), is being considered for approval by the Food and Drug Administration (FDA) this week. Truvada (TDF/FTC) is scheduled to go off patent in less than a year, allowing generic versions to enter the market — significantly lowering the cost of PrEP in the United States (currently $1,600 to $2,000 per month retail).

Our hope and the purpose of this article is to encourage the HIV community (persons living with or at risk for HIV, medical care providers and advocates) to be proactive in disseminating accurate scientific information and resources to help individuals starting or already receiving HIV treatment, and those using or considering PrEP to make decisions based on clinical facts rather than fear. 

What’s new about PrEP for HIV?

Just this past June, the U.S. Preventive Services Task Force, an independent (non-governmental) panel of experts that makes science-based recommendations on the safety and effectiveness of preventive medical screenings and medications, gave PrEP with Truvada a Grade “A” for clinical efficacy and safety — their strongest possible recommendation. 

In the recommendation statement, the Task Force clearly states that they “found convincing evidence that PrEP is of substantial benefit for decreasing the risk of HIV infection in persons at risk for HIV infection.” This is not surprising given that the Centers for Disease Control and Prevention (CDC) estimates PrEP as being 99% effective at preventing HIV in men who have sex with men and heterosexual men and women.   

In evaluating the potential harms of Truvada, the Task Force concluded that “PrEP is associated with small harms, including kidney and gastrointestinal adverse effects.”  Their recommendation confirms our collective clinical experience with prescribing Truvada for PrEP, as voiced by many of our members. As recommended by the CDC, all people on PrEP should be monitored for kidney functioning but, for the large majority of patients, the benefits far outweigh the risks.

 

What POZ has already reported on this

These safety issues and the effectiveness of PrEP have been well covered by POZ, most recently, a report from IAS 2019 on a session questioning the meaningful benefits of Descovy (TAF/FTC) relative to the cost of generic TDF/FTC.

Earlier a report covered a study finding that the safety concerns for Truvada (TDF/FTC) were linked to boosted regimens using low-dose ritonavir or cobicistat for treatment but, when comparing the use of the drugs for PrEP, the difference in safety profiles was significantly reduced.

Bottom line

After learning of the ads recruiting for lawsuits related to Truvada (TDF/FTC) one provider from a large Ryan White–funded clinic in Birmingham, Alabama, noted that, after being poised to take a significant step forward, we’re poised to take two steps back, causing serious repercussions.

At this point, we cannot afford any backsliding in our response to the HIV epidemic in the United States. The people who stand to benefit from PrEP and people living with HIV should be getting their health care advice from clinicians, not lawyers. Let’s do everything within our power to let them know that.

 

W. David Hardy, MD, is chair of HIVMA and Margaret L. Hoffman-Terry, MD, FACP, AAHIVS, is chair of AAHIVM. HIVMA represents more than 5,000 physicians and other health care professionals who provide HIV care and conduct HIV-related research in communities across the United States. AAHIVM is an independent organization representing over 3,500 health care professionals dedicated to providing excellence in HIV care and prevention. Together the organizations represent the majority of U.S. HIV clinicians and researchers.