Antiviral Drugs Advisory Committee approves pill to prevent HIV/AIDS in uninfected persons

A pill to prevent HIV could soon be available in what would be a major breakthrough in the three decade fight against the Aids epidemic. Truvada is currently used to treat the virus, but tests have shown it to be safe and effective in healthy people for preventing it.

The Food and Drug Administration concluded that taking the pill daily could spare patients ‘infection with a serious and life-threatening illness that requires lifelong treatment’.

A panel of US health experts for the first time yesterday backed a drug to prevent HIV infection in healthy people. The panel recommended US regulators approve the daily pill, Truvada, for use by people considered at high risk of contracting the Aids virus.

The US Food and Drug Administration (FDA) is not required to follow the panel’s advice, but it usually does. According to the Health Ministry, the drug, that has been available in Uganda since 2005, is said to be more effective in the prevention of mother to child transmission and also used as post exposure prevention treatment.

“Truvada is a combination of therapy composed of different drugs and it is more effective in the prevention of the mother to child transmission,” said Dr Asuman Lukwago, the permanent secretary of the Ministry of Health.

Dr Lukwago said Truvada is an ARV combination but medics have found out that taking it is one preventive measure as, “it reduces the chances of transmission of the virus and reduces the viral load.”

Without revealing the cost per dosage, Dr Lukwago explained that Truvada, a factory name for a combination of drugs, is among the expensive drugs and that the government is currently in discussion with the US government on how to make it available and affordable to Ugandans.

Research has shown that the pills are effective in discordant couples and it is also used in post exposure prevention. Some health workers and groups active in the HIV community have opposed the approval of the drug. However, correspondents say the move could prove to be a new milestone in the fight against HIV/Aids.

Truvada is already approved by the FDA for people who are HIV-positive, and is taken along with existing anti-retroviral drugs. Studies from 2010 showed that Truvada, made by California-based Gilead Sciences, reduced the risk of HIV in negative partners of people who are HIV positive - by between 44 per cent and 73 per cent.

The Antiviral Drugs Advisory Committee, which advises the FDA, voted 19-3 in favour of prescribing the drug to the highest risk group - non-infected men who have sex with multiple male partners.

They also approved it, by majority votes, for uninfected people with HIV-positive partners and for other groups considered at risk of acquiring HIV through sexual activity. The votes followed an 11-hour meeting of the panel in Silver Spring, Maryland, and a lengthy public comments session.

Opposition to the prospect of approving the drug is based on concerns that users could gain a false sense of security, and fears of a drug-resistant strain of HIV.

There is also concern that the high cost of Truvada could divert limited funding from more cost-effective options. “We need to slow down. I care too much about my community not to speak my concerns,” said Joey Terrill, of the Aids Healthcare Foundation, which campaigned against the drug’s approval.

Nurse Karen Haughey told the panel: “Truvada needs to be taken every day, 100 per cent of the time, and my experience as a registered nurse tells me that won’t happen. “In my eight years, not one patient that I’ve cared for has been 100 per cent adherent.”
But others welcomed the panel’s recommendation.

“This brings us closer to a watershed for global HIV prevention efforts,” said Mitchell Warren, executive director of the Aids Vaccine Advocacy Coalition, after the vote. The FDA is expected to make its decision by 15 June.

The Monitor Newspaper

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