FDA approved the new PrEP.

Reviewed by Dr.Deyn Natthakhet Yaemim, December 2019

DESCOVY

emtricitabine/tenofovir alafenamide (FTC/TAF)

After years of worrying about kidney problems and bone health issues, now we have the new PrEP that is safer for both kidneys and bone health. 

Descovy is the new Truvada in that it contains emtricitabine plus tenofovir alafenamide (TAF) instead of tenofovir disoproxil fumarate (TDF).  F/TAF delivers higher concentrations of tenofovir in cells, reaches protective levels more quickly, and maintains protective levels of drug in cells longer than F/TAF. For these reasons, it is possible–but not proven–that F/TAF for PrEP may be more effective than F/TDF for PrEP for people who miss doses. In the DISCOVER study, which demonstrated that F/TAF was “non-inferior” to F/TDF for PrEP (but did not determine that it was “superior” to F/TDF), there were fewer HIV infections among people taking F/TDF (11 infections) than among people taking F/TAF (6 infections; these numbers exclude people who had suspected acute HIV infections at baseline). Although there is some debate about whether F/TAF truly is “more effective” than F/TDF for PrEP, it is possible that F/TAF will provide better protection for people who miss PrEP doses and struggle with taking pills

What is better about combining with TAF is that it does not cause the same level of kidney problems or lower bone density that TDF does. Both Descovy and Truvada are recommended as first-line therapies in the HHS HIV treatment guidelines. Both are approved and recommended for hepatitis B. Descovy has not been approved for PrEP, however. It is important not to combine with other antivirals not prescribed by a doctor. Many new STRs already contain TAF. Drug interactions may occur, so tell your doctor about all the medications your take, including those sold over the counter.

If you are looking for the generic new PrEP, contact Pulse Clinic: info.silom@pulse-clinic.com.
Seven years after Truvada (F/TDF) was approved for HIV prevention as PrEP, we now have another PrEP medication option. On October 3, 2019, the U.S. Food and Drug Administration (FDA) approved the medication Descovy (F/TAF) as PrEP for people who are HIV-negative and at-risk for sexually acquired HIV through anal sex.


How is Descovy different than Truvada?

 

Truvada

Descovy

FDA Approval

August 2, 2004

April 4, 2016

Approved as PrEP

2012

October 3, 2019

Generic Name

emtricitabine 200mg
tenofovir disoproxil fumarate (TDF) 300mg

emtricitabine 200mg
tenofovir alafenamide (TAF) 25mg

Indications as PrEP

  • in at-risk adults and adolescents weighing at least 35 kg
  • in at-risk adult and adolescent men and transgender women weighing at least 35 kg 

Indications
for treatment

HIV-1 Infection
in adults and pediatric patients weighing at least 17 kg (in combination with other antiretroviral agents)

HIV-1 Infection
in adults and pediatric patients weighing at least 25 kg (in combination with other antiretroviral agents)

Pill Size

Larger

Smaller

Kidney problems

Occur around 3% of old PrEP users

Descovy (F/TAF) contains TAF, a prodrug of tenofovir that concentrates at higher intracellular levels

Good for

Younger PrEP users
PrEP users with good kidney functions

Older PrEP users
People who have compromised kidney functions or who otherwise maybe worried about side effects.

Recommended for daily dose?

Yes, Truvada and Truvada’s generics are good for daily dose.

Yes, Descovy and Descovy’s generics are good for daily dose.

Recommended for PrEP on demand (2-1-1)?

Yes, Truvada and Truvada’s generics are good for on demand use.

No, there have not been a large study of PrEP on demand using Descovy.

Recommended for Anal Sex?

Yes

Yes

Recommended for Vaginal Sex?

Yes

NO

Cost in USA

30-250 USD/ 30 tabs/ bottle

712-720USD

Cost in Thailand

90 USD/ 30 tabs/ bottle

Only Generics Available

Cost of Generic

30 USD/ 30 tabs/ bottle

100 USD/ 30 tabs/ bottle

 

Take home message: It is clear PrEP alternatives are evolving: In the next several years, patients may expect an array of additional options that include generic equivalents, injectables, implants and other options. You are free to chose what's best for your condition and your lifestyle. Contact our clinic now to discuss about your health and what prevention strategy suit you best. We are available all year long.

 

REFERENCES:

  1. Hare B, Coll J, Ruane P, et al. The phase III Discover study: daily F/TAF or F/TDF for HIV preexposure prophylaxis. Conference on Retroviruses and Opportunistic Infections, 4-11 March 2019, Seattle, Washington. Abstract 104.
  2. Humphries B, Xie F. Canada’s amendment to patented drug price regulation: A prescription for global drug cost control? JAMA. 2019;321(16):1565-1566.
  3. Califf RM and Slavitt S. Lowering cost and increasing access to drugs without jeopardizing innovation. JAMA. 2019;321(16):1571-1573.
  4. Hall AM, Hendry BM, Nitsch D, et al. Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence. American Journal of Kidney Diseases. 2011 May;57(5):773-80.
  5. Amrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature. 2019 Mar;567(7748):305-307

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