Truvada, HIV prevention pill approved by US approves

// Health | Truvada, HIV prevention pill approved by US approves
Email to a friend Plain text Print version // Font size: Decrease font Enlarge font
Truvada

The first-ever daily pill to help prevent against HIV was approved Monday by US regulators for use in uninfected adults who are at risk for getting the virus that causes AIDS.

Truvada, made by Gilead Sciences in California, has been on the market since 2004 and was approved by the Food and Drug Administration for a new use as a tool to help ward off HIV in otherwise healthy people, in combination with safe sex and regular testing.

The pill as pre-exposure prophylaxis (PrEP) has been hailed by some AIDS experts as a potent new tool against human immunodeficiency virus, but some health care providers are concerned it could encourage risky sex behavior.

In addition, the regimen is estimated to cost around $14,000 per year, making it out of reach of many.

“Truvada alone should not be used to prevent HIV infection,” said Debra Birnkrant, director of the division of antiviral products at the FDA.

“Truvada as PrEP represents another effective, evidence-based approach that can be added to other prevention methods to help reduce the spread of HIV.”

The FDA said Truvada should be used as “part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.”

Truvada was previously approved as a treatment for people infected with HIV to be used in combination with other antiretroviral drugs.

The decision by the FDA followed the advice of an independent panel in May that supported Truvada for prevention in uninfected people, after clinical trials showed it could lower the risk of HIV in gay men and heterosexual couples.

One study on Truvada, called the iPrEx trial, published in 2010 in the New England Journal of Medicine included 2,499 men who were sexually active with other men but were not infected with the virus that causes AIDS.

Participants were selected at random to take a daily dose of Truvada — a combination of 200 milligrams of emtricitabine and 300 milligrams of tenofovir disoproxil fumarate — or a placebo.

Those in the study who took the drug regularly had almost 73 percent fewer infections. Across the entire study, including those who had not been as diligent in taking Truvada, there were 44 percent fewer infections than in those who took a placebo.

A second study on 4,758 heterosexual couples in which one partner was infected with HIV and the other was not, showed that Truvada reduced the risk of becoming infected by 75 percent compared with a placebo.

Experts have described the results as game-changing and the first demonstration that an already-approved oral drug could decrease the likelihood of HIV infections.

Common side effects were the same as experienced by people with HIV who were taking Truvada, and included diarrhea, nausea, abdominal pain, headache, and weight loss.

However, adherence rates — meaning how often people in the study actually took the drug daily — were low in the study of men who have sex with men, just 30 percent, Birnkrant said.

In the study of heterosexual partners, adherence was much higher, between 80 and 90 percent.

Therefore, the drug label must include special instructions for health care providers on how to counsel potential users of the drug.

The drugmaker must also include a warning that Truvada for PrEP “must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use.”

Gilead Sciences is also required to collect samples from people who test positive for HIV while taking the drug and analyze them for signs of drug resistance.

As to concerns about whether the pill might boost risky sex practices and lead people to abandon condoms as a first line of protection, Birnkrant said the studies have not shown that so far.

“We don’t really have any strong evidence to show that condoms were not used or that there was a decrease in condom use when Truvada was used,” she told reporters.

The goal of the approval is to eventually cut back on the rate of new infections in the United States, which have stayed steady in recent years at about 50,000 annually, she said.

A key goal of the US strategy against HIV/AIDS, set forth in 2010, is to decrease the number of new infections by 25 percent by 2015.

“The hope is that over time it will decrease the rate of new infections or incidence in the United States.”

Tagged : AIDS, Truvada, HIV prevention pill

Headlines Newsview all

Cossy Orjiakor: I Am Looking For Husband

Highly endowed controversial Nollywood actress, Cossy Orjiakor, has made it known that she is looking for a husband. The actress, who does not see any big ... Full story

OMG!! African Village Where Dead Children Are Made Into Voodoo Dolls (Photos)

Raising twins is never easy but in Benin, an poor nation on the west coast of Africa, hardship means many die during childhood. Now a ... Full story

Burna Boy And Cynthia Morgan Caught Kissing (Photo)

The Nigerian dancehall queen, Cynthia Morgan, has kept her relationship status a secret until recently when rumours linked her with fellow dancehall singer, Burna Boy. The ... Full story

Shocking!! Vigilance Group Uncovers Naked Female Dancers Joint In Asaba

An Asaba-based vigilance group has uncovered a joint where female teenagers dance naked and has arrested the operator of the joint. The joint, located in Asaba, ... Full story

OMG!! Church Of Pentecost Sunday School Teacher Caught Acting Porn In Italy

Church Of Pentecost Sunday School Teacher Caught Acting Porn In Italy ... Full story

Kanye West Announces He Wants To Run For Presidency In 2020

Kanye West says he is running for president in 2020. But could he do it harder, better, faster, stronger than everyone else?  The rapper made his announcement ...

EFCC Sets Up 4 Man Panel To Probe Former Minister Of Petroleum Resources, Diezani Alison-Madueke

The Economic and Financial Crimes Commission has commenced a full investigation into the activities of the immediate past Minister of Petroleum Resources, Mrs. Diezani Alison-Madueke, ...

P-Square involved in a ghastly auto crash on their way back from a concert in Ibadan

Peter and Paul Okoye of the popular pop duo, Psquare, on Sunday, escaped death by whiskers in a ghastly auto-crash along the Lagos-Ibadan Expressway. The Sensational ...

Fresh trouble for Goodluck Jonathan and Alison-Madueke

As president Muhammadu Buhari continues his anti-corruption fight, fresh trouble is already brewing up for the Goodluck Jonathan administration, as the probe of the past ...

Nigerian Air Force Plane Crash In Kaduna Leaves Seven Dead

A plane belonging to the Nigerian Air Force (NAF) air crashed Saturday morning at the old Nigeria Defense Academy (NDA) in Kaduna also known as ...

Can You Imagine!! Why I Am Unmarried - Dbanj

Dbanj has revealed why he stalled his plans to get married at 30.The singer who has been linked to several beauties revealed to Saturday Beats… “While ... Full story

Comment on: Truvada, HIV prevention pill approved by US approves

Rate this article

0

Breaking News

Cristiano Ronaldo Spends £20,000 On Waxwork Of Himself (Photos)

Football superstar Cristiano Ronaldo has spent £20,000 on a waxwork of himself to take pride of place in his Spanish mansion. The Real Madrid player paid ... Full story

Tonto Dikeh Reveals Her Engagement Ring Costs Over 12 Million Naira (Do You Agree?)

For the past few weeks, Nollywood actress, has been trending due to his marriage brouhaha.Just yesterday, her Mr. X, Oladunni Churchill, stormed to her hometown ...

Liz Benson, Shan George, Other Nollywood Actresses Visit New Rivers State Governor (Photos)

It was a filled and joyful sunday service at Obudu Cattle Ranch as Nollywood veteran actresses, Liz Benson, Shan George, actresses Halima Abubakar and ChaCha ...

Top 5 Celebrity Couples 2015

The year is fast coming to an end and there are couples in the industry that have either been seen on the red carpet together ...

Pastor Bakare's First Daughter Weds In London

The first daughter of Pastor Tunde Bakare, Olubunmi walked down the aisle with her heartthrob, Olaoluwa Fabode on Saturday, August 29. A number of popular faces ...

Shocking!! Liverpool 0-3 West Ham

A blistering start by West Ham United at Liverpool culminated in a stunning 3-0 victory on the road for Slaven Bilic’s men. Philipe Coutinho and Mark ... Full story

Heavily Pregnant Mercy Johnson And Hubby Loved Up On Her Birthday (Photos)

A stunning and pregnant Mercy Johnson celebrated her birthday with her husband and kids . She looks amazing! ... Full story

So Touching! Story Of The Childhood Friend Who Made Cristiano Ronaldo Famous

Cristiano Ronaldo has given his old friend and former football teammate, Albert Fantrau a special recognition publicly after recounting how he sacrificed his own football ... Full story

Real Love Comes With A Choice Not A Chance

When all the butterflies have fluttered away and your wedding day becomes a distant memory, you will discover that you’ve married someone who is just ...

Shocking!! She Said I Am Not The Father Of 2 Our Children - James Adedapo

Mr James Adedapo, a retired civil servant has got a nod for his divorce suit against his wife, Oluwatoyin, at the Grade ‘C’ Customary Court ...