The immune systems of HIV patients who are obese does not respond to antiretroviral therapy as well as do those of people of normal weight, according to a study conducted by researchers from the Uniformed Services University of the Health Sciences (USU). The findings were was based on data collected by the USU’s Infectious Disease Clinical Research Program (IDCRP) from participants in the U.S. Military Natural History Study, which includes 1,119 people with documented dates of HIV infection between 1986 and 2008.
It was presented recently at the annual meeting of the Infectious Diseases Society of America.
“Obese patients were found to regain fewer CD4-positive T cells after they start therapy than do people with normal weight,” said presenter, Dr. Nancy Crum-Cianflone. “These findings don’t align with some of the earlier studies done prior to the advent of modern highly active antiretroviral therapy (HAART), when patients who were obese did better than those of normal or below-normal weight,” she said. Crum-Cianflone said this recent data may imply that obesity ? which has known ill effects ? poses an additional risk to people with HIV.
“The irony is that in the past we have been concerned that patients with HIV infection were losing too much weight,” said Captain (Dr.) Greg Martin, director of the IDCRP. “Yet this research is showing that there needs to be more of a focus on maintaining a balanced weight without going to the other extreme.”
Crum-Cianflone said it is not clear why obesity should have such an effect ? one possibility might be that standard drug dosing set in clinical trials may not be enough for obese patients, or there may be something about the extra weight that limits the effects of medications.
FDA approves Gardasil to prevent genital warts in males
The U.S. Food and Drug Administration recently approved use of the Gardasil vaccine for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26. Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.
Gardasil was first approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer; precancerous lesions and genital warts caused by certain types of HPV.
HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.
“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.
In studies Gardisil was shown to be nearly 90 percent effective in preventing genital warts caused by infection with two types of HPV.
. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, were the most common side effects observed.
FDA approves new cervical cancer vaccine
The FDA recently approved Cervarix as a new vaccine to prevent cervical cancer and precancerous lesions caused by two types of human papillomavirus (HPV). It is approved for use in girls and women ages 10 years through 25.
Genital HPV infections are the most common sexually-transmitted diseases in the United States, and HPV types 16 and 18 are the cause of about 70 percent of cervical cancers worldwide. There will be an estimated 11,270 new cases and 4,070 deaths from cervical cancer in the United States during 2009, according to the National Cancer Institute at the National Institutes of Health.
“It has the potential to save lives from cervical cancer as well as reduce the need for biopsies and invasive procedures associated with the necessary follow-up from abnormal Pap tests,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.
The primary clinical study for Cervarix included more than 18,000 women ages 15 years through 25 in the United States and 11 other countries. Of these women, about 9,000 received Cervarix and 9,000 a licensed hepatitis A virus vaccine as a control. The results showed that among women who had not already been infected by HPV types 16 and/or 18, Cervarix was about 93 percent effective in preventing precancerous cervical lesions caused by these HPV types.
The current data show that Cervarix provides protection for about 6.4 years, but additional information on the length of protection is forthcoming.
No vaccine is 100 percent effective, and regular Pap tests continue to be recommended for all women who receive Cervarix. Pap screening remains critically important to detect precancerous changes, which would allow treatment before cancer develops.
The most commonly reported adverse reactions in the Cervarix group included pain, redness, and swelling at the injection site, fatigue, headache, muscle and joint aches, and gastrointestinal distress.
Women who are pregnant, or think that they may be pregnant, or plan to become pregnant during the vaccination course, should not use Cervarix, which is administered in three separate shots, with the initial dose being followed by two additional shots at one and six months.
FDA approves Lysteda for heavy menstrual bleeding
Lysteda tablets (tranexamic acid) are the first non-hormonal product cleared by the FDA to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.
Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition.
“Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, M.D., FDA’s associate commissioner of women’s health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”
Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.
The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking a placebo.
Use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. Women using hormonal contraception should take Lysteda only if there is a strong medical need, and if the benefit of treatment will outweigh the potential increased risk.