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June 14, 2012

Treating HIV Positive Women

by Joe DeCapua

New research shows that a combination of inexpensive antiretroviral drugs can be very effective in treating HIV positive women in developing countries. In fact, new research shows the treatment is just as effective as a much more expensive drug combination. However, the study also shows the cheaper drugs can carry a greater risk side effects.

Antiretroviral drug treatment has proven effective in suppressing the AIDS virus and saving lives. The drugs have changed the prognosis of the disease from one of certain death – usually within 10 years – to a chronic illness.

In 2010, the World Health Organization recommended that treatment of HIV infected women in poor areas should include the drug navirapine. It’s inexpensive and is often used in preventing the transmission of HIV from mothers to their newborns.

Research at Brigham and Women’s Hospital in Boston shows navirapine, in combination with other antiretrovirals, is just as effective as another combination that costs a lot more. Dr. Shahin Lockman led a study of 500 HIV infected African women who were in advanced stages of HIV/AIDS.

“There is very little known about the optimal regimen to use in persons living with HIV in resource-limited settings and in particular women living with HIV globally. The burden of HIV disease really is in resource-limited settings,” she said.

Resistance

Lockman is an associate professor of medicine at Harvard Medical School. She said the study of the navirapine-based combination looked at possible drug resistance. It’s known that when navirapine is given to women by itself – not part of a combination – resistance can develop.

“Many women are diagnosed with HIV and first enter the HIV care system when pregnant. And they are then offered often just one or two antiretroviral drugs to try and interrupt transmission of HIV to their baby. But these drugs, in particular single dose navirapine, which a woman takes during labor and gives one dose to her baby, while somewhat effective in reducing transmission to the baby, leaves three-quarters of the women with detectable drug resistant virus,’ she said.

The question is did that same drug resistance to navirapine occur when combined with several other antiretrovirals? The answer is no. But there was other good news, as well.

“In the women who had not previously taken single dose navirapine about 83 percent of women were able to suppress their virus and stay alive and well after starting the navirapine based regimen. So comparing that to the best first line regimens that we have here in the U.S., where the success rate is closer to 90 to 95 percent, 83 percent is not perfect, but it’s solidly good,” said Lockman.

However, while it was not as good as regimens here in the U.S., it was as good as a much more expensive regimen that is available in some developing countries. The downside of the navirapine combination, however, is the side effects.

“A reasonable number of patients had to switch off of navirapine treatment because of toxicity. And that was not particularly surprising. So about 14 percent of the women had to stop navirapine because of toxicity,” she said.

Navirapine can be toxic to the liver and skin. Lockman said if treatment is not stopped soon enough after symptoms appear, women can develop a “life-threatening drug sensitivity reaction.” Women in the study were closely monitored, though, and given a different drug regimen if necessary. But women not in such a study and not closely monitored could be at risk. Some may simply stop taking the drugs and forego treatment. And without treatment, Lockman said, they will die. She added that women deserve better.

“We really do need to push to get safer, better tolerated more effective treatment accessible so that even if you only have one or perhaps two lines of treatment the majority of people who start these can stay on them for life without toxicity,” she said.

She estimated millions of women need such treatment. She said PEPFAR - the President’s Emergency Plan for AIDS Relief - and the Clinton Global Initiative are some of best efforts to achieve that goal. 

The study was funded in part by the National Institute of Allergy and Infectious Diseases and the National Center for Research.