The Food and Drug Administration (FDA) recently approved the drug Truvada for the prevention of HIV infection in healthy people who are HIV-negative. Truvada isn’t a new drug–it comprises a combination of two anti-HIV drugs that work by preventing the virus from replicating itself–but its approval as a preventive drug, as opposed to a treatment for existing HIV infection, is completely new.
The Potential Impact of Truvada
The motivation behind the new recommendation is clear. The incidence of new HIV cases continues to hold steady at about 50,000 per year in the US, despite extensive counseling and advertising about the use of condoms and other safe sex practices. Truvada can decrease the incidence of new cases by up to 90 percent over several years if the drug is taken faithfully–one pill every day.
Causes for Concern
So surely this new indication for Truvada is a win for everyone, right? Well, not so fast. There are several reasons to be cautious.
In studies, as few as 1 in every 10 people took the drug faithfully, both lowering the efficacy of the medication and raising the possibility of of HIV resistance to Truvada. Everyone who takes Truvada must undergo frequent HIV testing, because giving the drug to a person who turns HIV-positive could increase the risk of producing a resistant strain that could then be introduced into the general population. There’s also some concern that taking Truvada might encourage a false sense of security in users, and they will no longer feel compelled to practice safe sex. Finally, the drug is very expensive (about $14,000 for one year’s supply without insurance coverage), and has numerous potential side effects, including gastrointestinal symptoms, decreased bone density, and renal failure.
Despite these caveats, the lowered risk of contracting HIV can be so dramatic that most clinicians and public health officials think that the benefits of Truvada outweigh the harm, and that the drug should be offered to high-risk HIV-negative people who can be expected to take the it as directed and come in for frequent testing.
The use of Truvada to prevent infection is a double-edged sword, and at One Medical, we’ll be monitoring the impact very closely as the drug gains wide acceptance.