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

Helen Ukpabio Sues Two UK Human Rights Group For £500M Over Witchcraft Allegation

Nigerian preacher, Helen Ukpabio, has sued two UK human rights groups – The British Humanist Association (BHA) and Witchcraft and Human Rights Information Network (WHRIN) ... Full story

Atiku Abubakar, former Vice President, to declare presidential ambition on September 24

A former Vice President, Atiku Abubakar, is considering to declare his 2015 presidential ambition on Wednesday, September 24, 2014. As part of the preparations, sources close ...

Boko Haram Takes Over Bama In Borno State, Hoists Flag

Fresh reports emerging from Bama, in Borno State, indicate that Boko Haram militants have taken over control of the second city in Borno state after ...

Christ Embassy Church Issues Gets Hotter As Pastor Oyakhilome's Brother Rev. Ken, Impregnates His South African Mistress

The crisis rocking the Christ Embassy Church is about to get messier as The Nigerian Times claims that Rev. Ken Oyakhilome, younger brother of Pastor ... Full story

Pastor Chris Oyakhilome's Divorce Getting Messier: Christ Embassy Deletes All Anita Oyakhilome's Data From Website

Latest findings  indicates that Pastor Chris Oyakhilome of the Christ Embassy has removed every information about his estranged wife, Anita from the church’s website. This is ... Full story

Clara Chime, Enugu State First Lady Apologizes To Husband In Public

Wife of Enugu State gov­ernor, Mrs. Clara Chime, who, last year, quit the Governor’s Lodge, where she lived with Governor Sul­livan Chime after she alleged ... Full story

Ebola In Port Harcourt: Three New Suspected Cases Involving A Pharmacist, Doctor And A Nurse

Three people have been taken to the Ebola Virus Disease quarantine centre at Oduoha, Emohua Local Government Area of Rivers State. The State Commissioner for Health, ... Full story

Negotiator reveals some powerful Nigerians don’t want Chibok girls released

There are indications that some who is who in the country are sabotaging the efforts of the Federal Government to ensure that the over 200 ...

Chris Oyakhilome's divorce splits Christ Embassy church members

Members of the Christ Embassy are divided over a divorce suit filed against the Senior Pastor of the church, Chris Oyakhilome, by wife, Anita, in ...

Ebola Outbreak: 39 immigrants from DR Congo, Sierra Leone arrested at two hotels in Lagos

Lagos-At least 39 foreign nationals were yesterday arrested by Police and Immigration officers in two hotels on Lagos Island. It was gathered that they were arrested ... Full story

Maheeda - ‘I Had S3x With Davido’

Just when you think you’ve seen and heard it all from Maheeda, she digs into her bag of mischief for more tricks. A few weeks ... Full story

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

Rate this article

0

Featured author

chuky01

Breaking News

BREAKING: Music Star, Slam Makes ‘Sweeter’ Return To Music

Report just reaching us has it that well known artiste, Slam, whose real name is Udoka Oguamanam, has returned to the music industry after a ...

Kid Superstar, Ozzy Bosco Begins ‘Keep Lagos Clean’ Project (Video)

Brand ambassador of the Lagos State Waste Management Authority (LAWMA), Oziomachukwu Mojekwu, well known as Ozzy Bosco has kicked off his pet project tagged ‘Keep ...

Genevieve Nnaji’s Red Dress, Hit Or Miss?

Nollywood actress, Genevieve Nnaji sure knows how to rock an outfit to any event. The pretty and well loved role-interpreter recently wore a 'Hudayya Couture' ...

Watch Monalisa Chinda’s 6-Year-Old Daughter Display Singing Skill

Like the Yorubas fondly say, ‘one can tell a prosperous Sunday from a Saturday’. This saying can rightly be applied to the cute daughter of ...

Joke Silva, Kate Henshaw, Others Dazzle In ‘The Wives’ Photo Shoot

Kate Henshaw, Joke Silva, Iretiola Doyle and Lala Akindoju. A new play titled ‘The Wives’ has brought together an array of movie stars and from information ...

Black Nigerian woman gives birth to white baby [Photos]

A mother has beaten odds of a million-to-one by giving birth to a baby who appears to be of a different race.Catherine Howarth, 32, from ...

I'm Single--Daniella Okeke Declares

It is hard to believe that someone as pretty as Nollywood actress, Daniella Okeke would be single, but the actress has emphatically stated that she ...

GOSPEL SINGING COUPLE GOZIE & NJIDEKA OKEKE RECONCILE AT LAST

Njideka and Gozie Okeke News filtering in from eastern Nigeria is that Gospel singing couple, Gozie and Njideka Okeke have reconciled and are back together as ...

Arsenal sign Danny Welbeck from Manchester United

Arsenal have completed the €20 million signing of Danny Welbeck from Manchester United. The deal was struck late on Monday night to bring the England international ...

Anita, Pastor Oyakhilome’s Wife, ‘Excused’ From Church Website

Anita Oyakhimole, estranged wife of Pastor Chris Oyakhilome, has had details about her removed from the church’s website as the divorce mess between the pair ...