US experts urge approval of first AIDS prevention pill

US health advisers urged regulators to approve Truvada, made by Gilead Sciences, as the first preventive pill against HIV/AIDS instead of just a treatment for infected people.

The favorable vote came after clinical trials showed Truvada could lower the risk of HIV in gay men by 44 to 73 percent, and was hailed by some AIDS advocates as a potent new tool against human immunodeficiency virus.

However, many concerns were raised during a marathon 11-hour panel meeting in which about three dozen health care providers warned that the pill could boost risky behaviors and possibly lead to a drug-resistant strain of HIV.

The Food and Drug Administration is not bound by the recommendations of its expert panel, but usually follows the advice. A final decision by the FDA is expected by June 15.

Mitchell Warren, executive director of HIV prevention group AVAC, said after the vote that pre-exposure prophylaxis (PrEP), or the method of taking a drug ahead of potential exposure to HIV, "while not a panacea, will be an essential additional part to the world's success in ending AIDS."

"For the millions of men and women who remain at risk for HIV worldwide, each new HIV prevention option offers additional hope," he added.

The drug, made by the California-based Gilead Sciences, is currently available as a treatment for people with HIV in combination with other anti-retroviral drugs, and received FDA approval in 2004.

The panel's nod came in response to the pharmaceutical company's request for a supplemental new drug application to market it for prevention purposes.

The Antiviral Drugs Advisory Committee voted for the drug as a preventive measure for three groups: 19-3 in favor for men who have sex with men, 19-2 with one abstention for couples in which a partner is HIV positive and 12-8 with two abstentions for other at-risk groups.

Gay men account for more than half of the 56,000 new HIV cases in the United States each year, according to the Centers for Disease Control and Prevention (CDC).

But critics noted that the pill is costly -- up to $14,000 per year -- and could offer a false sense of protection, leading to a spike in unsafe sex and a new surge in AIDS cases.

"We need to slow down. I care too much about my community not to speak my concerns," said Joey Terrill, advocacy manager at the AIDS Healthcare Foundation, which campaigned against the drug's approval for PrEP.

There also remains some controversy about who would benefit from the treatment, as trials in women have shown feeble results, possibly due to poor adherence to the regimen.

"I am concerned about the potential for development of resistance," said Roxanne Cox-Iyamu, a doctor who spoke at the panel's meeting.

"I am concerned as a black woman that we don't have enough data that this actually works in women."

Nurse Karen Haughey said Truvada will not work because "it is not in our nature to always do as human beings what we are told 100 percent of the time."

She also said Truvada's main side effects -- diarrhea and risk of kidney failure -- were a major deterrent.

The main set of data considered came from the iPrEx HIV Prevention Study, carried out from July 2007 to December 2009 in six countries -- Brazil, Ecuador, Peru, South Africa, Thailand and the United States.

The study was conducted among 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.

After publication in 2010 in the New England Journal of Medicine, some experts hailed the results as game-changing and the first demonstration that an already-approved oral drug could decrease the likelihood of HIV infections.

Joseph McGowan, medical director of the Center for AIDS Research and Treatment at North Shore University Hospital in New York, said the CDC was expected to soon issue guidance for health professionals who may prescribe the drug.

"I don't see it as something that would be useful to the general public but to certain people who are particularly high risk, there may be some benefit," he said.

Loading...

Editor’s note:Yahoo Philippines encourages responsible comments that add dimension to the discussion. No bashing or hate speech, please. You can express your opinion without slamming others or making derogatory remarks.

  • Sandigan OKs hospital stay for GMA co-accused
    Sandigan OKs hospital stay for GMA co-accused

    The Sandiganbayan has allowed a government official, accused with plunder along with former President and now Pampanga Rep. Gloria Macapagal-Arroyo to undergo a medical procedure at a hospital tomorrow. The anti-graft court permitted former Philippine Charity Sweepstakes Office (PCSO) board member Benigno Aguas to undergo a cardiopulmonary/endocrine clearance at the St. Luke’s Medical Center in Quezon City. …

  • Sandigan recommends executive clemency for ex-envoy
    Sandigan recommends executive clemency for ex-envoy

    The Sandiganbayan has recommended executive clemency for a former Philippine ambassador to Nigeria who was sentenced to 52 years for malversation of public funds. The Sandiganbayan First Division found Masaranga Umpa guilty of misusing the Assistance-To-Nationals Stand-by Funds totaling $80,478.80 in 2007, but the anti-graft court said the former assemblyman from Lanao del Norte should be pardoned. …

  • Stargazing at the mall highlights Earth Hour
    Stargazing at the mall highlights Earth Hour

    It was a night of stargazing in 58 SM Supermalls all over the country last night as these establishments participated in Earth Hour, an annual worldwide movement encouraging communities and establishments to switch off lights for one hour to raise global awareness of overuse of non-renewable resources. The Philippines has been an active participant of Earth Hour since 2008. Last night, in the province of Bulacan, for instance, all parishes, diocesan institutions, schools and household …

  • Payanig privatization hit
    Payanig privatization hit

    BLEMP Commercial of the Philippines, Inc. (BLEMP) denounced the recent announcement of the Presidential Commission on Good Government (PCGG) to privatize the 18.4-hectare “Payanig sa Pasig” property. In a statement sent to The STAR, BLEMP lawyer Dennis Manalo said the PCGG has no right to auction the property because it has no valid title and is not in possession. The PCGG has not paid a single centavo in real property taxes for the property, he said. He narrated that it was in the early 70s …

  • New species of tarantula found
    New species of tarantula found

    Scientists from the Museum of Natural History (MNH) of the University of the Philippines-Los Baños have discovered a new species of cave-dwelling tarantula on an island off the coast of Quezon. The new species of the spider, Phlogiellus kwebaburdeos, was described in the recent issue of the Philippine Journal of Systematic Biology by MNH curators for spiders Aimee Lynn Dupo and Alberto Barrion along with their former student Joseph Rasalan. The tarantula was discovered by Rasalan during one …

  • Palm Sunday: Do not add to suffering of others
    Palm Sunday: Do not add to suffering of others

    As Christendom enters Holy Week today, Palm Sunday, an official of the Catholic Bishops’ Conference of the Philippines (CBCP) yesterday called on the faithful not to add to the sufferings of their fellowmen. Jerome Secillano, executive secretary of the CBCP-Episcopal Commission on Public Affairs (ECPA), said that while Palm Sunday is oftentimes remembered as the glorious arrival of Jesus Christ in Jerusalem, it also signals the start of the Holy Week that tells of His suffering, death and …

  • Miriam pushes tougher graft law
    Miriam pushes tougher graft law

    Sen. Miriam Defensor-Santiago has filed a bill that would make public officials liable for violations of the Anti-Graft and Corrupt Practices Act even if they are elected to a fresh term or a new position. In filing Senate Bill 2716, Santiago sought to address what she said was the doctrine of condonation in Philippine jurisprudence brought about by the 2010 case of Salumbides vs. Ombudsman. “By merely asserting the doctrine of condonation, erring elective officials are automatically given a …

  • Phl hits back at China over sea infra work
    Phl hits back at China over sea infra work

    The Philippines assailed China yesterday for contesting Manila’s planned repair and maintenance works on some islands in the West Philippine Sea, saying they are “in no way comparable” to the Asian power’s massive reclamation activities which are in violation of international laws. “The Philippines’ possible undertaking of necessary maintenance and repairs on its existing facilities in the West Philippine Sea, over which the Philippines rightfully exercises sovereignty, sovereign rights and …

POLL

Should Aquino be held accountable over the Mamasapano operations?

Loading...
Poll Choice Options