Medical Front Page

By: Ed Susman

SEATTLE, WA – Treatment with lopinavir/ritonavir (Kaletra) reduced the risk that HIV-infected children would become co-infected with malaria, researchers said.

Compared with treatment based on non-nucleoside reverse transcriptase inhibitors, therapy with the protease inhibitor-based combination resulted in a 41% decrease in the incidence of malaria, said Jane Achan, MD, lecturer in pediatrics at Makerere University of Health Sciences, Kampala, Uganda.

The incidence rate was 2.25 malaria cases a year among those treated with non-nucleoside reverse transcriptase inhibitors and 1.32 cases a year with those on the protease inhibitor (P=0.04), she reported at the Conference on Retroviruses and Opportunistic Infections.

Achan suggested that lopinavir/ritonavir might have a direct antimalarial effect or it might enhance the antiparasitic effects of lumefatrine, prolonging that drug’s usefulness in the bloodstream. “This study highlights the possible role of ‘pharmaco-enhancement’ as a tool for reducing the burden of malaria in highly endemic settings,” Achan said.

The open-label study was conducted among children in Tororo, Uganda – a region of high malaria incidence. The study population included children ages 2-6 who met standard criteria for the initiation of antiretroviral therapy or who were already treated with antiretrovirals and had suppressed viral loads.

Participants were randomly assigned to either a lopinavir/ritonavir-based regimen or therapies based on either nevirapine (Viramune) or efavirenz (Sustiva). Treatment was provided at a medical clinic daily.

In the trial, 86 children with a median age of 3.1 were assigned to one of the non-nucleoside reverse transcriptase inhibitors, and 84 children with a median age of 2.9 were assigned to lopinavir/ritonavir. Two-thirds of the children were naïve to antiretroviral therapy at baseline.

Achan reported that 176 malaria events were observed among the patients on non-nucleoside reverse transcriptase inhibitors compared with 109 events among the children receiving the protease inhibitors. Differences in risk of infection with malaria began to emerge within 30 days of treatment.

There was a 29% reduction of the first episode of malaria (P=0.14) and a significant reduction in recurrent malaria – 59% (P=0.004).

The overall 41% reduction in malaria was largely based on a significant reduction in recurrent infections within 30 days in those treated with the antimalarial combination of artemether-lumefantrine.

The improvement in malaria control was achieved without an increase in adverse events, Achan said. “There were no significant differences in the risk of adverse events following antimalarial therapy between the two antiretroviral arms except for transient elevations in liver enzymes which were more common in the non-nucleoside reverse transcriptase inhibitor treatment arm and pruritis occurred more often in the protease inhibitor arm,” she said.

“This trial indicates that in areas where malaria is highly prevalent, treatment with lopinavir/ritonavir appears to provide another level of benefit,” Elaine Abrams, MD, professor of pediatrics and epidemiology at Columbia University, New York said.

Although the studies were conducted in areas in which infant HIV prevalence and malaria prevalence is high, Abrams suggested the studies could influence treatment with protease inhibitors in children in Western countries as well.

- MFP Wire Services
- 03-23-2012

By: Ed Susman

SEATTLE, WA – Neurological development of children infected with HIV does not appear to be influenced by the decision on when to start antiretroviral therapy, researchers said.

Full scale IQ scores at week 144 averaged 75 for HIV-infected children who underwent immediate antiretroviral therapy; those who were not treated with HIV-suppressant therapy until CD4-positive cell counts dropped had an average score of 74, not a significant difference, said Jintanat Ananworanich, MD, deputy director for scientific affairs for the HIV Netherlands Australia Thailand (HIV-NAT) collaboration in Bangkok.

However, children who were infected with HIV appeared to be at much higher risk for neurological deficits than non-infected children, she said at a press briefing during the Conference on Retroviruses and Opportunistic Infections.

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Children who were not HIV-positive, including those born to HIV-infected mothers, had IQ scores that averaged 86 (HIV-exposed) and 90 (not HIV-exposed) – scores that were significantly higher than those of children who were HIV-infected (P<0-0.001), Ananworanich reported.

"Poorer performance on neurodevelopmental testing among HIV-positive children may be related to early HIV insult to the brain," she suggested. "The optimal window of opportunity in antiretroviral initiation remains early in infancy." Children in the study were a median of 9 years old.

"In this study, the researchers started with children who had survived the roughest period for babies," said Elaine Abrams, MD, professor of pediatrics and epidemiology at Columbia University, New York. “So in these older children, both groups did very well after initiation of therapy. We know from earlier studies that infants do better when treated early.

“We know that this virus likes the brain and we know that the baby brain is very vulnerable to the virus. In these groups the children are starting therapy later and perhaps the damage to the brain has already been done before they even got to the benefit of antiretroviral treatment,” Abrams said.

She said that in addition to the early injury to the brain caused by the virus, the infected children could have more illness than their non-HIV-infected counterparts, and that there is likely to be less illness overall in the non-HIV household, which could have an impact on neurological development.

Ananworanich and colleagues assigned 135 children to immediately begin therapy with antiretrovirals while a second group of 145 children did not begin antiretroviral therapy until their CD4-positive cell counts dropped at least 15%. About 51% of the children were girls in the immediate therapy group; 60% were girls in the delayed group.

The children were followed for 144 weeks, during which time all the early treatment group were on therapy; the delayed treatment group were treated for about 81 weeks.

At week 144, the immediate group, had a median CD4-positive cell count of 793 cells/mm3 compared with a median of 493 cells/mm3 among the children who had delayed therapy (P<0.001).

Although both groups of children showed no differences in tests that studied processing speed, visual motor integration and memory scores, in all these tests, the study children scored lower than non-infected children, Ananworanich said.

“Compared with non-infected children, about 60% of the HIV-infected children have significantly lower IQ scores and motor skill scores,” Ananworanich said.

- MFP Wire Services
- 03-22-2012

By: Ed Susman

SEATTLE, WA – Women who use oral contraceptives do not appear to have any increased risk of acquiring HIV, researchers said.

In a retrospective study, combined oral contraceptive use was associated with a non-significant 12% reduction in the risk of HIV infection (P=0.54) and women who used progestin oral contraceptives had a 2% increased risk of HIV infection (P=0.94), Sandra McCoy, MPH, PhD, an adjunct epidemiologist at the University of California, Berkeley, reported.

But, depending on the types of statistical analyses employed, there was a 37% increased risk of HIV acquisition with injected hormonal contraceptives, McCoy said, during the Conference on Retroviruses and Opportunistic Infections.

Even if that risk is real, McCoy suggested that the benefits of contraception would likely outweigh the risk. “There are numerous benefits to effective and reliable hormonal contraception,” she said. “There are significant social, economic, and health benefits, such as reductions in unwanted pregnancy, maternal morbidity and mortality, and infant mortality.”

“All of our results need to be placed in context with the availability of effective and reliable contraception. It is very possible that even if there were an increased risk with injectable contraception, it might not be big enough to outweigh all of the amazing benefits of contraception,” she said.

Her study grew from reports at the International AIDS Society which suggested an increased risk of HIV with contraceptive use. McCoy recognized that research work already performed by her group might hold answers to the controversy.

“We conducted a secondary data analysis of an HIV prevention trial conducted among women in South Africa and Zimbabwe,” she explained. “This question is of great importance because 140 million women worldwide use hormonal contraception. Overall, we had 4,866 women in the study and we observed 274 seroconversions, an incidence rate of 4.1 per 100 women-years.”

“If you look by type of hormonal contraception used, we saw no effect among women who used oral contraceptive pills. Our conclusions are consistent with the World Health Organization recommendations for dual protection with condoms for women who are at risk for infection with HIV.”

In another study presented during a Conference on Retroviruses and Opportunistic Infections-sponsored press briefing, Renee Heffron, MS, a PhD candidate, at the University of Washington, Seattle, specifically reviewed HIV rates among HIV-infected women who used injectable hormonal contraceptives.

When compared with 1,817 women who did not use contraception, there appeared to be a protective effect for contraception.

After a multivariate analysis, Heffron reported that women who used no contraception experienced disease progression at a rate of 12.31 per 100. Women who used any form of contraception experienced disease progression at the rate of 8.54 per 100 (P=0.04). The 324 women who used injectable methods had a progression rate of 8.58 (P=0.03).

The 95 women using oral contraceptives in this study had a progression rate of 8.39, but because there were far fewer women using this method in this study the result failed to reach statistical significance (P=0.80), Heffron said.

“Based on these results, it is reassuring that we don’t see that injectable contraceptives have a detrimental effect on HIV-1 disease progression,” she said.

McCoy noted, “We are going to refine our estimates and prepare this information for publication in a peer viewed journal. We used an advanced statistical technique that we would also like to further test and define.”

- MFP Wire Services
- 03-22-2012