When AIDS Healthcare Foundation President Michael Weinstein slammed the use of Gilead Sciences’ controversial antiretroviral drug Truvada as HIV prevention for risking being turned by gay and bisexual men into a “party drug,” his remarks were met with a barge of criticism by the LGBT community.
But not even one decade later, Truvada is at the center of two high-profile class-action suits alleging not that the medication has encouraged promiscuous behavior among a certain population group but because it has spurred irreversible health issues in die-hard users, many of them being in long-term monogamous relationships.
What Is PrEP & Why Is it So Controversial?
HIV Pre Exposure Prophylaxis, in short PrEP, is a controversial strategy of protecting sexually active HIV-negative recipients against HIV infection with antiretroviral drugs. The only drugs for PrEP that got the FDA’s nod are Truvada (tenofovir disoproxil fumarate and emtricitabine) and Descovy (tenofovir alafenamide and emtricitabine), both manufactured by Gilead.
PrEP Is designed to protect the groups with a higher-than-usual risk of contracting HIV through sex or injection drugs. These groups include HIV-negative gay and bisexual men, heterosexual partners having sex with HIV-positive heterosexual partners, sex workers, and adult injection drug users.
PrEP has been widely criticized due to legitimate concerns about the potential emergence of drug-resistant HIV strains and uncontrollable STI spread among PrEP users. The former concern was quickly dismissed by Truvada proponents since there are no long-term studies to confirm the risk (Truvada was approved for PrEP by the FDA in 2012).
The latter concern, however, couldn’t be dismissed so easily as even Truvada’s most fervent pushers, such as Gov. Andrew Cuomo’s administration once candidly admitted that, “Some people use condoms, some people don’t. You can’t offer condoms to people who don’t want them.”
In other words, Truvada is a promising HIV prevention drug in high-risk sexually active groups that refuse to wear condoms to protect themselves. But the issue with Truvada and Descovy alone is that they cannot shield the user against other STIs like syphilis and Gonorrhea, which is why regular screenings are recommended.
Truvada for PrEP: The Pros
Let’s give credit where credit is due. Truvada has helped curb the risk of HIV infection in high-risk groups, especially men who sleep with other men, also known as MSM. Between 2005 and 2011, one in five MSM admitted to regularly having unprotected sex. No wonder this group has had the highest infection rates.
It is estimated that around 38,000 people are diagnosed with HIV every year in the USA, which marks a 7% decrease from 2014. Much of the progress was attributed to PrEP and awareness-raising efforts.
Truvada has also helped many heterosexual couples with one HIV-positive partner conceive or have safe sex without the fear of passing on the disease to the healthy partner. Moreover, drug users sharing drug injection equipment, such as needles, syringes, and/or cookers, take Truvada to keep themselves AIDS-free if their injecting partner(s) are HIV-positive or their HIV status is unclear.
Truvada has also proven useful as an HIV prevention strategy in people who:
- Enjoy casual sex, have anonymous sex partners, or have sex with partners who have multiple and/or anonymous sex partners whose HIV status is unclear;
- Are engaged in “transactional sex,” which means that they offer sex for money, drugs, food, housing, etc.
- Have had an STI diagnosis over the last six months;
- Belong to a high-risk group and are receiving post-exposure prophylaxis (PEP);
- Request PrEP even if they refuse to disclose the behaviors that might put them at risk.
Truvada for PrEP: The Cons
Truvada is not a “morning-after” pill. For users to enjoy the full effects, it needs to be taken religiously once a day, every day as long as you plan on staying sexually active. It is estimated that its effectiveness drops from 99% to 70% or lower if the user doesn’t take it consistently. Also, PrEP needs around seven days for receptive anal sex and three weeks for receptive vaginal sex to reach maximum effect when taken daily.
According to a small study, taking four doses of Truvada immediately before and after sexual intercourse could help slash the risk by 97%. Yet, that study needs more evidence. Like with nearly all Truvada research, it is unclear if the effectiveness at keeping HIV at bay is due to the drug itself, condom use, or both. It is well known that most people who know about PrEP and Truvada take their sexual health seriously and routinely use condoms.
Another major drawback of Truvada for PrEP is that it does not prevent sexually transmitted infections. It is only effective against HIV-1 infection. To keep STIs away, doctors recommend using condoms, which defeats the drug’s purpose for the people who would rather go condom-free every now and then. As per official recommendations, Truvada users should get screened for STIs every three months or so since some STIs up the risk of HIV infection.
But Truvada for PrEP has drawn the most fire due to the major adverse effects longtime users have experienced, such as kidney disease, bone density loss, and liver problems. And to add fuel to the fire, Gilead Sciences allegedly kept secret a less toxic alternative to Truvada because the alternative would have been cheaper.
A 30-day dose supply of Truvada now costs between $1,500 and $1,800, even though there is already available a “cheaper” generic Truvada on the U.S. market as Gilead’s patent for emtricitabine is set to expire this fall.
Truvada’s side effects are mainly tied to tenofovir disoproxil fumarate (TDF) and may include:
- Worsening of hepatitis B infection;
- Kidney disease, including kidney failure and Fanconi’s syndrome;
- Dangerous lactic acid buildup in your blood, aka lactic acidosis (Common symptoms of lactic acidosis include abnormal heartbeat, nausea, fatigue, stomach ache, muscle pain, fast breathing, shortness of breath, weakness, and/or cold hands and feet);
- Liver disease flare-ups (Common symptoms include dark urine, nausea, loss of appetite, stomach pain, yellowing of the white part of eyes and skin);
- Bone density loss even in young people (This side effect may lead to osteoporosis, brittle bones, bone fractures, bone pain, and bone thinning and softening).
There are two pending class-action lawsuits and multiple undisclosed private civil lawsuits against Gilead Sciences, but no settlements have been reached to date. It is estimated that the severity of injuries caused by the drug maker’s misconduct could spur “significant” settlements. (Check out this Truvada lawsuit update for the latest developments.)