Nevirapine

Il farmaco Nevirapine riduce del 75% il rischio di infezione da madre a feto.
E' quanto emerso da questo nuovo studio.
La Nevirapine si aggiunge cosi' ai farmaci utilizzati principalmente per la riduzione del rischio di tramissione Hiv materno-fetale.

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Nevirapine achieves 75% reduction in HIV transmission risk from mother to breastfeeding infants
Written By: Nadia on March 4, 2011 0

Giving breastfeeding infants of HIV-infected mothers a daily dose of the antiretroviral drug nevirapine for six months halved the risk of HIV transmission to the infants at age 6 months compared with giving infants the drug daily for six weeks, according to preliminary clinical trial data presented today.

The longer nevirapine regimen achieved a 75 percent reduction in HIV transmission risk through breast milk for the infants of HIV-infected mothers with higher T-cell counts who had not yet begun treatment for HIV.

The study was presented at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.

“Extended breastfeeding reduces infant mortality in places that lack safe, clean water by protecting babies from common childhood diseases because breast milk contains protective antibodies from the mother that formula feeding does not provide,” says Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, which funds the trial. “These findings show that giving the infants of HIV-infected mothers an antiretroviral drug daily for the full duration of breastfeeding safely minimizes the threat of HIV transmission through breast milk while preserving the health benefits of extended breastfeeding.”

The new findings apply to mothers and infants in developing nations, where infectious diseases such as gastroenteritis and pneumonia often pose a life-threatening risk to very young children. The U.S. Department of Health and Human Services recommends that HIV-infected mothers in the United States feed their babies with infant formula, not breast milk, because safe and affordable formula is available, infant deaths due to infections are low and only total avoidance of breastfeeding will completely protect these infants from HIV transmission through breast milk.

This advanced-stage clinical trial known as HPTN 046 is co-funded by NIAID, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute on Drug Abuse and the National Institute of Mental Health, all part of NIH. The HIV Prevention Trials Network and the International Maternal, Pediatric and Adolescent AIDS Clinical Trials Network are conducting the trial under the leadership of Hoosen Coovadia, M.D., M.B.B.S., of the University of the Witwatersrand in Durban, South Africa. Bonnie Maldonado, M.D., of Stanford University in Stanford, Calif., presented the study results for Dr. Coovadia on March 2, 2011, at CROI.

More than 1,500 mother-infant pairs in South Africa, Tanzania, Uganda and Zimbabwe are participating in HPTN 046, which began in February 2007 and will conclude in July 2011. The participating infants received daily nevirapine for the first six weeks after birth. Those infants who remained free of HIV then were assigned at random to receive either daily nevirapine or a placebo until six months after birth or the cessation of breastfeeding, whichever came first. Study investigators compared the rates of HIV infection in the two groups of infants, and evaluated and compared the safety and tolerance of nevirapine in the infants.

The primary analysis of study data found that 2.4 percent of the infants who received six weeks of nevirapine had acquired HIV through breastfeeding by 6 months of age, but only 1.1 percent of the infants who received six months of nevirapine had acquired HIV through breastfeeding by that time-a 54 percent difference. After the preventive nevirapine regimen was discontinued at six months, however, the rate of subsequent HIV transmission via breastfeeding was the same whether the infants had received daily nevirapine for six weeks or six months.

The percentage of infants who experienced serious health problems was nearly the same in both groups (17 percent in the six-week group and 19 percent in the six-month group). The great majority of these problems were infectious diseases not associated with nevirapine, such as diarrhea, malaria or pneumonia. Only 5 percent of the infants in each group had a health problem that required temporarily stopping daily nevirapine.

In addition, the HPTN 046 study team analyzed the impact of the mother’s health and antiretroviral treatment on the benefit of providing daily nevirapine to breastfeeding infants for six months rather than six weeks. One group the investigators evaluated was the infants of mothers who had a T-cell count of at least 350 cells per cubic millimeter of blood, and who thus did not yet require antiretroviral therapy according to World Health Organization guidelines. In these infants, the six-month nevirapine regimen cut HIV transmission through breast milk by 75 percent relative to the six-week regimen.

In infants born to women with a T-cell count lower than 350 cells per cubic millimeter who received antiretroviral therapy for their own health, viral transmission to infants through breast milk was zero or nearly zero regardless of the duration of infant nevirapine.

HIV transmission through breast milk occurred at the highest rates among infants born to mothers who had a T-cell count lower than 350 cells per cubic millimeter but did not receive antiretroviral therapy even though they qualified for it. However, the difference in HIV transmission rates between the two infant drug regimens was not statistically significant.

The investigators will conduct their final analysis of the HPTN 046 study data after all infants have completed 18 months of follow-up this summer.

Source: NIH/National Institute of Allergy and Infectious Diseases

Inoltre qui dice che il prezzo e' molto piu basso rispetto al Kaletra per cui potrebbe essere usato molto di piu nei paesi del terzo mondo.

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New HIV/AIDS study could turn treatment 'on its head'

2011-03-04 16:40:00

HIV / AIDS Latest Study
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A new study of anti-HIV/AIDS medicines in the developing world is on the verge of turning "the whole treatment world on its head," says expert.

Paul Palumbo, of pediatric medicine at Dartmouth Medical School, has shed light on the IMPAACT's findings in Africa and India.

The IMPAACT P1060 trials - comparing the effects of different forms of treatment on infants and young mothers - began in 2006. On October 27, 2010, an independent data and safety monitoring board (DSMB), which confidentially reviews large clinical trials on an interim basis for safety and efficacy of drugs, halted the second phase of P1060, declaring that the protease inhibitor lopinavir (LPV/r) was working so well among infants with no previous exposure to the popular anti-retroviral nevirapine (NVP) that the IMPAACT team didn't need to go further in the head-to-head trials between LPV/r and NVP to prove their point.

"We were a little surprised, anticipating the trial would run to March of 2011. We didn't expect such a superior difference," said Palumbo.

In the spring of 2009, the DSMB halted the first phase of the P1060 trial involving 164 HIV-infected children ages 6 to 35 months, after learning that a cohort of 82 youngsters responded better to treatment with LPV/r than did a cohort of 82 children in the same age group who had received NVP.

The difference from the current study cohort was that all 164 children in the first-phase cohort had previously received a single dose of NVP in liquid form at birth, and their mothers had taken NVP in the form of a single pill during labor in an effort to prevent transmission of HIV.

When these children, who were HIV-infected despite efforts to prevent mother-to-child transmission, later required HIV treatment, they were enrolled into the P1060 trial and randomly assigned to therapy with the antiretroviral drugs Zidovudine and Lamivudine, plus either NVP or LPV/r - the latter also known as Kaletra.

The treatment with LPV/r proved superior enough for WHO to recommend that infants with HIV infection and exposure to NVP at birth start on an LPV/r-based regimen whenever possible.

"These studies help equip us with strategies to deal with the current imperfections in our scale-up efforts. With new WHO guidelines calling for increased access to therapy and prophylaxis ... the goal of eradicating pediatric HIV is within sight," wrote the authors.

Within distant sight, Palumbo cautions, especially in sub-Saharan Africa and India.

"Nevirapine is relatively cheap to produce and distribute. Kaletra (LPV/r) is four times more expensive, and it needs a little help because it doesn't do well in high-temperature environments without much refrigeration. Much of the world is used to having access to something inexpensive," he said.

The findings were unveiled by the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) during the 2011 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. (ANI)