Monday, April 25, 2016

Experimental antiretroviral treated vaginal ring

I've been reading JAMA for about 30 years, and reports of using African women and children as lab animals never cease to surprise me, because the benefits are usually accrued to western women. All the early contraceptive testing of 50+ years ago by the major drug companies, some really harmful; many nutrition tests on babies some getting supplements, some not, which could never be done in Europe or the USA; bed nets for malaria prevention when the disease was all but conquered by DDT before Rachel Carson.
" Antiretroviral medications that are used as prophylaxis can prevent acquisition of human immunodeficiency virus type 1 (HIV-1) infection. However, in clinical trials among African women, the incidence of HIV-1 infection was not reduced, probably because of low adherence. Longer-acting methods of drug delivery, such as vaginal rings, may simplify use of antiretroviral medications and provide HIV-1 protection. Abstract
The latest I saw is an experimental antiretroviral treated vaginal ring, randomized, double-blind, placebo-controlled study in Malawi, South Africa, Uganda and Zimbabwe.  168 acquired HIV, 71 from the treated ring group and 97 from the placebo group. And when data from 2 sites were excluded, there was higher rates of protection. I wonder how the researchers obtained consent? I wonder if the women were told that the only way to avoid HIV is no sex at all, since being sexually active was one of the requirements to participate. And I looked through the instructions.  Compliance must have been rough. And for 18-21 year olds there was low adherence--no surprise there. In most cases, an investigational drug must be proven effective and must show continued safety in a Phase III clinical trial to be considered for approval by FDA for sale in the United States.

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