ARV gel almost ready to roll out

quraisha

In the time it takes parents to see their children grow from birth to adulthood, the vaginal gel containing the antiretroviral tenofovir has been under close and intense scrutiny.

Now nobody is more keen to see the fast-track roll-out of the life-saving microbicide than Professor Quarraisha Abdool Karim.

Research initiated 20 years ago at the Medical Research Council and in the past ten years at Caprisa finally culminated in a definitive proof that a microbicide, namely tenofovir gel, reduces the risk of women contracting HIV.

“Twenty years might sound a long time,” she said this week, “but this sort of science requires painstaking input from every member of the research team. We have had to ensure that every avenue – from concept to proof – has been covered. Now that we can prove that tenofovir gel works, we are looking forward to implementing the next step.”

That next step, awaiting approval from the Medicines Control Council, will test the feasibility of integrating tenofovir gel provision into family planning services.

As a principal researcher in the Caprisa 004 scientific research programme, Abdool Karim demonstrated that the gel prevented both HIV and Herpes Simplex Virus (HSV) Type 2 infection.

It’s a finding that has been lauded as one of the most significant scientific breakthroughs in the fight against Aids by WHO, UNaids and several leading organisations

“But there is no time to rest on these laurels,” she says. “There is much work still to do.”

She has revealed that a public-private company has identified a factory site on the KwaZulu-Natal south coast to manufacture tenofovir gel.

Taking the implementation process forward, a second Caprisa study (008), she explained, is testing the roll-out of tenofovir gel through family planning clinics in KZN.

“We need to examine the feasibility and acceptability of providing a microbicide through existing health services that target sexually active women.”

Two trials, she said, are under way to confirm the first trial, which found that the infection rate among the women who received the tenofovir microbicide was 39 percent lower than those who did not get the gel.

“The Voice trial is currently under way in a number of African countries,” she said “that will compare the efficacy of tenofovir gel with tenofovir tablets, as well as comparing tenofovir with another ARV called Truvada.”

The Facts 001 trial, she said, under the leadership of Dr Helen Rees, will replicate the Caprisa 004 trial in several other South Africa sites.”

Caprisa, she explained, also has a study in place to follow-up women who became HIV infected after exposure to Tenofovir gel, to monitor drug resistance, and also if there are any differences in disease progression and responses to tenofovir containing ARV treatment regimens compared to non-tenofovir exposed HIV infected women.



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