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What is Truvada: Ingredients and Known Generics

What is Truvada: Ingredients and Known Generics

Truvada has been around for more than a decade as an HIV treatment and pre-exposure prophylaxis (PrEP) for HIV-negative individuals who are at high risk of contracting the disease. Truvada as PrEP is a promising approach to reducing the spread of HIV transmission. The combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is expected to curb the global burden of HIV, where more than 38,000 Americans became newly infected annually. The most affected population are gay and bisexual men, accounted for 67% of all diagnoses. Diagnoses in other populations have declined since 2011.

  • Heterosexual contact – declined by 15%
  • Women – declined by 16%
  • People who inject drugs – declined by 17%

However, in low to mid-income nations, the rate of new infections is surpassing the rate of initiation of antiretroviral therapies (ART). The biggest problem with PrEP, aside from adherence, is it remains inaccessible to other populations at risk. Some are being turned away from clinics whose trial places are full.2 The branded Truvada cost about $1,500 a month or $18,000 a year. Even if insurers and patient assistance programs cover much of the cost, a generic version will likely reduce the cost by 80%. The nucleotide/nucleoside reverse transcriptase analogs TDF and FTC are the only agents approved for prophylaxis treatments. Truvada is the only coformulated regimen that has demonstrated effectiveness and safety in research trials and clinical populations. Antiretroviral therapy is an important milestone in HIV/AIDS management because people with undetectable viral load carries no risk of transmitting the virus sexually.

Is There a Generic Truvada?

In June 2017, the Food and Drug Administration has approved the first generic version of Truvada under Teva Pharmaceuticals. Teva’s emtricitabine and tenofovir tablets 200mg/300mg will be bioequivalent and therapeutically equivalent to Gilead’s reference drug. Gilead still owns the patent for the drug in some regions.

Gilead’s European patent has expired in July 2017, but the company is seeking to expand the patent by filing an injunction request to prevent the launch of generic versions. Generic manufacturers such as Accord Healthcare have been challenging Gilead’s supplementary protection certificate (SPC), a move to protect Truvada from generic competitions. The SPC will grant Gilead protection until 2020. But recently, the High Court of England and Wales have ruled that Gilead’s Truvada SPC was not valid.

Why Truvada has not been widely adopted as PrEP?

When Truvada was first declared as a viable preventive treatment for HIV, public health officials expected a rush of high-risk individuals demanding the drug. Many even predicted a stampede in health clinics. But according to Gilead Science’s records, only 3,253 people had taken Truvada from half of the U.S. pharmacies that dispensed the drug between January 2012 and March 2014. If there were half a million Americans estimated to be good candidates for PrEP, why only a few people would take Truvada? Various factors were cited as contributing factors for the low number of PrEP takers. First is the drug’s high cost, which is about $1,300 per month without insurance, plus additional expenses for office visits and laboratory works. Another is the criticisms from advocates group, including AIDS Healthcare Foundation. Some people in the gay community argues that people on PrEP use the drug as an excuse to engage in unsafe sexual practices. They added that it is an encouragement to people who refuse to use condoms. The fact that PrEP does not protect against sexually transmitted infections, condomless sex only makes high-risk groups more vulnerable to STIs. As all antiretroviral meds, Truvada has some negative side effects. Relatively healthy people do not appreciate suffering from side effects when they are not even infected.

It would be a triumph in HIV management and prevention if generic versions of Truvada would become widely available, especially in high-density regions: East and Southern Africa. Research trials in the US, South America, Asia, and South Africa has opened sites to enroll men who have sex with men and transgender women who have sex with men into long-acting injectable PrEP study. The development of long-acting version of PrEP is much anticipated in the field of HIV/AIDS prevention. If it becomes successful, getting an injection every 4–8 weeks would be easier and more convenient to uninfected users than taking a daily Truvada pill.

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