Anti-HIV Pill: U.S. Gives Nod to Commercial Availability of New Drug
A new HIV-suppressing pill gained the approval of the U.S. Federal and Drug Administration recently, paving the way for its commercial sale in the United States and possibly in other countries soon.
In a statement issued on Monday, the FDA identified the new anti-HIV cocktail as Stribild, which the health regulator said is composed of four antiviral drugs namely elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate, all meant to stop the onset of AIDS.
Emtricitabine and tenofovir disoproxil fumarate, the FDA said, have been in existence since 2004 in the form of Truvada, which like Stribild formed a powerful concoction that inhibits the growth and replication of HIV inside an afflicted person.
Neutralising HIV has been the core functions of anti-AIDS drug products as scientists blamed the virus for the debilitating disease, which upon reaching full-blown phase strips a person's basic immune system and leaving him vulnerable to all sort of infections and complications.
In many cases, advance stage of AIDS is irreversible and fatal, according to medical doctors.
But with the availability of pills like Stribild and Truvada "these drugs provide a complete treatment regimen for HIV infection," the FDA said.
Stribild itself packs all the components needed to hold off HIV from flourishing as its make-up attacks the ability of the AIDS virus to effectively wreak havoc on a person's body.
"Elvitegravir is an HIV integrase strand transfer inhibitor, a drug that interferes with one of the enzymes that HIV needs to multiply. Cobicistat, a pharmacokinetic enhancer, inhibits an enzyme that metabolizes certain HIV drugs and is used to prolong the effect of elvitegravir," the FDA said on its statement.
Stribild is a once-a-day treatment, according to its manufacturer Gilead Sciences, which added that the pill is geared for the exclusive use of adult AIDS patients with no previous record of treatment for the disease.
Tests conducted by Gilead Sciences on 1408 patients yielded results that showed 48 weeks of continues Stribild treatment could lead to between 88 and 90 per cent of undetectable HIV on their blood.
Compared with Truvada and another pill called Atripla, the undetectable level of HIV went only a high of 87 per cent, the FDA said.
With the anti-HIV pills on its current go-list, more HIV-infected patients in the United States and other parts of the world can go on with their lives normally, the U.S. health agency said, by managing their health condition in almost the same way that diabetes patients handle their situation.
However, like any other drugs to combat the ill-effects of HIV, Stribild also comes with notable side effects such as nausea and diarrhoea with some patients like to experience a build up of lactic acid in the blood and severe liver problems, which if left unchecked could lead to death.
"Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome)," the FDA said.
Also, the new pill is not recommended for use of patients with chronic hepatitis B virus infection, the health agency added.
The FDA also assured that more tests on Stribild will be conducted by Gilead Sciences in order to "further characterize the drug's safety in women and children, how resistance develops to Stribild, and the possibility of interactions between Stribild and other drugs."