As the quest to eradicate HIV continues, the US Food and Drug Administration have recently approved the first generic version of Truvada for the treatment and prevention of HIV-1 infection. Along with other antiretroviral agents, the FDA has revealed that Truvada's generic version can be considered as bioequivalent and therapeutically equivalent to the reference-listed drug.
While Teva Pharmaceutical Industries has been the first manufacturer of the generic drug, an HIV prevention group believes that with the introduction of Truvada's generic form, more generic drug makers are seen to do the same thing.
Generic Truvada for HIV
In one of their statements, the US FDA assures the public that those generic drugs that are being approved by them have the same high quality and strength as brand-name drugs. That said, to be qualified, the FDA explains that generic manufacturing and packaging sites should pass the same quality standards as those of brand-name drugs. As of the present time, however, Teva has not yet revealed how much will the drug cost or as to when will it be available to patients.
Meanwhile, generic versions of the said drug are already being marketed in other nations. In 2013, it can be recalled that the Strides Arcolab Limited in India was able to create their version of Truvada which has also been approved by the FDA. It was said that Strides' version was used outside the United States under a White House AIDS relief program. Unfortunately, the said generic drug has not been made available in the United States it was found that the drug was under a patent protection.
Prohibitions of Truvada
According to the FDA, unless a negative test result is confirmed, the use of Truvada for a PrEP prescription is not recommended for patients with signs or symptoms of HIV infection. Authorities have also warned women who are pregnant not to take the said drug while they are on their breastfeeding stage.
Ultimately, Mitchell Warren, executive director of AVAC, an international organization that promotes HIV prevention, said that Teva Pharmaceutical's generic version of Truvada could reduce the cost of PrEP by as much as 80%. By doing so, he believes that those patients who are in dire need of financial help will greatly be assisted.