Sometimes multi-drug combinations are better than one. A recent NIH study shows promise that a triple drug regimen may be helpful in preventing mother-to-child HIV transmissions. For HIV infected women in good immune health, taking a three drug regimen during pregnancy is more effective than one drug during pregnancy, another during labor, and two more after giving birth. The NIH study is called “Promise – Promoting Maternal-Infant Survival Everywhere.” The study found the one three drug regimen is shown to be safer than another for other pregnant women and their babies. According to the NIH data, 3,500 HIV-infected pregnant women or post-partum women did not meet the national guidelines and criteria for obtaining anti-HIV treatment. The study also notes that more than 3,200 babies exposed to HIV were infants of women who lived in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe.
Globally, this is an issue of utmost importance in controlling HIV transmissions to unborn babies. There were two drug regimes tested: One is giving women zidovudine as early as 14 weeks into the pregnancy, a single dose of nevirapine during labor, and two weeks of tenofovir, and emtricitabine after delivery OR giving women one of two triple anti-HIV drug regimens as early as 14 weeks into the pregnancy. The three drug regimen of lamivudine, zidovudine and ritonavir-boosted lopinavir (the lamivudine combination) or tenofovir, emtricitabine, and ritonavir-boosted lopinavir (the tenofovir combination) seemed the most helpful in preventing mother-to-baby HIV transmissions. The DSMB (Data Safety Monitoring Board) concluded that the lamivudine was safer than other medication regimes.
All of the infants in the study receive a daily dose of nevirapine until they are six weeks old and those who acquire an HIV infection from their mothers are given a combination of anti-HIV therapy. The women who participated in the study are being followed approximately two years after their last child is born. This is so safety and the effectiveness of the drugs can be monitored during breastfeeding times. In addition, the study is also accessing maternal health after breastfeeding periods for women who are in good immune health which either stop or continue taking the triple drug combination.
“We now have the gold standard of evidence – data from a randomized clinical trial – supporting a three drug regimen as the preferred approach for preventing HIV transmission from an infected mother to her baby during pregnancy and delivery,” said Anthony S. Fauci, M.D., and director of the National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health. This is another important step in our efforts to define the best approaches toward the goal of eliminating of mother-to-child HIV transmission globally,” said Fauci.
Clinical trials and studies do a great justice to the community by informing and educating healthcare providers, patients, and drug manufacturers. Without these trials and studies we would be lost in the fight against finding drugs that work and ones that prove less than beneficial in helping patients with health problems and fighting disease. Those who participate in clinical trials do a huge favor to the healthcare community and provide another avenue for drug research and better healthcare in the world today. To learn more about the National Institutes of Health and other NIH studies, please go to www.nih.gov.
1. Leifman, Laura. “NIH Sponsored Study Identifies Drug Regimen For Preventing Mother-To-Child HIV Transmissions.” NIH.Gov Press Release. 17 Nov 2014.