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Two new algorithms can identify patients at risk of HIV

The final risk prediction model included such variables as sex, race, living in a neighborhood with high HIV incidence, use of medications for erectile dysfunction, and sexually-transmitted infection (STI) testing and positivity.

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Two new studies developed algorithms that can identify patients who are at risk of acquiring HIV and may benefit from preventive care. Both studies appear in the July issue of The Lancet HIV.

Preexposure prophylaxis (PrEP) is an antiretroviral pill that is over 90% effective in preventing HIV acquisition when taken as prescribed. PrEP was recently given a Grade A recommendation from the U.S. Preventive Services Task Force but is vastly underutilized. There are nearly 40,000 new HIV infections annually in the United States, yet the Centers for Disease Control and Prevention estimates that only 7% of the 1.1 million individuals at substantial risk for HIV infection used the antiretroviral pill in 2016.

One barrier to use is the difficulty for providers in identifying patients who are at high risk of HIV acquisition. Providers often have limited time, may have limited knowledge about PrEP, and may lack training in how to talk to patients about sex or substance use. Risk prediction tools, a form of electronic clinical decision support using the data in patients’ electronic health records (EHRs), are often used in other areas of medicine. Researchers from both studies, one using a patient population in California and the other in Massachusetts, built HIV risk prediction models that could be used in EHRs as automated screening tools for PrEP.

The two studies looked back at the medical records of millions of patients who were HIV-uninfected and had not yet used PrEP. Researchers extracted demographic and clinical data from these patients’ EHRs on numerous potential predictors of HIV risk. A machine-learning algorithm automatically selected important HIV risk-related variables for the final models.

READ:  PLHIVs ask PhilHealth to reconsider HIV response

In the California-based study, which used medical record data of 3.7 million patients at Kaiser Permanente Northern California, the final risk prediction model included such variables as sex, race, living in a neighborhood with high HIV incidence, use of medications for erectile dysfunction, and sexually-transmitted infection (STI) testing and positivity. The model flagged 2% of the general patient population as potential PrEP candidates and identified 46% of male HIV cases, but none among females.

“Although risk prediction tools are imperfect and cannot replace the clinical judgement of skilled providers, our algorithms can help prompt discussions about PrEP with the patients who are most likely to benefit from it,” said Julia Marcus, PhD, MPH, lead author of the California-based study and Assistant Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School.

The Massachusetts-based study used a patient population of 1.1 million patients at Atrius Health as well as the population of Fenway Health, an independent community health center in Boston specializing in sexual health care, to test performance in a new setting with higher rates of new HIV infection. The final risk prediction model included sex, race, primary language, as well as diagnoses, tests, or prescriptions for STIs. The model flagged 1.8% of the general patient population at Atrius Health and 15.3% of the population at Fenway Health as potential PrEP candidates. The model also identified 37.5% of new HIV cases at Atrius Health and 46.3% at Fenway Health.

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According to Douglas Krakower, MD, lead author of the Massachusetts-based study and Assistant Professor at Beth Israel Deaconess Medical Center, the Harvard Pilgrim Health Care Institute, and Harvard Medical School, “integrating these prediction models into primary care with routine, comprehensive HIV risk assessments by clinicians could play an important role in increasing the prescription of PrEP and preventing new HIV infections.”

Jonathan Volk, MD, senior author of the California-based study and an infectious disease physician at Kaiser Permanente San Francisco Medical Center added that “a recent publication by the U.S. Preventive Services Task Force in JAMA cites the lack of effective prediction models as a major gap in research that is critical to improving PrEP delivery. Our model helps fill that gap.”

The California study, titled “Use of electronic health record data and machine learning to identify potential candidates for HIV preexposure prophylaxis: a modelling study”, is co-authored by investigators from: Harvard Pilgrim Health Care Institute, Kaiser Permanente Division of Research, Beth Israel Deaconess Medical Center, and Kaiser Permanente San Francisco Medical Center. The project was supported by the Kaiser Permanente Northern California Community Benefit Research Program, the National Institute of Allergy and Infectious Diseases, and the National Institute of Mental Health.

The Massachusetts study, titled “Development and validation of an automated HIV prediction algorithm to identify candidates for preexposure prophylaxis”, is co-authored by investigators from: Beth Israel Deaconess Medical Center, Harvard Pilgrim Health Care Institute, Massachusetts Department of Public Health, Boston Medical Center, Atrius Health, New England Quality Care Alliance, Brown University, The Fenway Institute, and Brigham and Women’s Hospital. The project was supported by the National Institute of Mental Health, Harvard University Center for AIDS Research, Providence/Boston Center for AIDS Research, Rhode Island IDeA-CTR, and the US Centers for Disease Control and Prevention through the STD Surveillance Network.

READ:  13th PNCA calls for stakeholders to review, re-commit to their roles in HIV prevention & TCS

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Does timing matter for initiating HIV therapy in infants?

The success of attaining and sustaining viral suppression was similar in the 46 infants starting ART less than two days old (51 percent) and the 27 infants starting therapy between 2 and 14 days after birth (54 percent).

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Starting HIV antiretroviral therapy (ART) within hours of birth has been hypothesized to have positive effects raising the possibility of remission in some children with HIV. To test the hypothesis, researchers at Columbia Mailman School of Public Health and Columbia University Irving Medical Center designed a trial in a group of newborns with HIV who started ART within 14 days of birth.

The results showed that about 75 percent of infants attained viral suppression on ART; but only 52 percent attained and sustained viral suppression on ART. The success of attaining and sustaining viral suppression was similar in the 46 infants starting ART less than two days old (51 percent) and the 27 infants starting therapy between 2 and 14 days after birth (54 percent). The findings are published online in E-Clinical Medicine.

“The results of our trial suggest that very early treatment in newborns may not have to mean within hours of birth,” said Louise Kuhn, PhD, Columbia Mailman School professor of epidemiology (in the Sergievsky Center). “We learned that we must be more attune to basing decisions about how quickly to start ART on optimizing maternal adherence with treatment rather than with just focusing on speed. While we certainly do not want to introduce undue delay, starting ART within the first two weeks of life led to similar outcomes to starting within the first two days of life.”

The study was designed shortly after the report of the infant in Mississippi who started antiretroviral treatment within 30 hours of birth and who was able to maintain viral suppression off treatment for over two years. This case report led to optimism that ART started within hours of birth may lead to protection of critical immune processes and smaller viral amounts, making possible remission in a sizable minority of infants treated in this way. “The outcome in Mississippi raised the tantalizing possibility that we may be able to facilitate remission in infants if we start ART very early in life,” noted Kuhn.

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To yield the target population for the trial, clinical protocols were established at Rahima Moosa Mother and Child Hospital (RMMCH), Johannesburg, South Africa. The analysis included 73 children who were born between March 1, 2015 and September 30, 2017 with confirmed HIV infection and ART initiated within 14 days. The initial ART regimen consisted of nevirapine, lamivudine and zidovudine; nevirapine was replaced with lopinavir-ritonavir once the child reached 42 weeks post-menstrual age, usually about 4 weeks of age in calendar time. ART was initiated based on results of the first round of diagnostic testing and was continued throughout the study.

Of those surviving during the study, 75 percent attained viral load <50 copies/ml on ART but not all of these sustained this low level of virus. Dividing the group into the 46 infants who started ART less than two days old and the 27 infants starting ART between 2 and 14 days old, showed a similar percent achieving and sustaining viral load <50 copies/ml on ART. In the very early treated infants (less than 2 days old), 51 percent achieved and sustained viral suppression; in the early treated infants (2 to 14 days old), 53 percent achieved and sustained viral suppression.

“Viral suppression rates, especially to more stringent cut-offs than required by our protocol were lower than expected, and we concluded that very early ART on its own, with routinely-available regimens, is unlikely to lead to remission in a sizable minority of early-treated infants,” said Kuhn. This is most likely explained by the significant challenges of adequate maternal adherence with ART for neonates and infants including major practical difficulties of sustaining adherence with twice-daily, poorly-palatable liquids for infants. Moreover, most of the study participants’ caregivers live in impoverished economic circumstances with complex social problems and experience a high degree of HIV-related stigma.

READ:  13th PNCA calls for stakeholders to review, re-commit to their roles in HIV prevention & TCS

“We need to find interventions to treating newborns that are reasonable for mothers to fully adhere to,” said Kuhn. Long-acting formulations and/or alternative interventions may be more adherence-friendly and need to be investigated. These may enable more rapid and sustained viral control and immune recovery in a larger proportion of early treated infants as a stepping stone to achieve remission.

Co-authors are Stephanie Shiau, Elaine Abrams, and Wei-Yann Tsai, Columbia Mailman School; Yanhan Shen, Columbia Sergievsky Center; Renate Strehlau, Faeezah Patel, Karl-Günter Technau, Megan Burke, Gayle Sherman, Ashraf Coovadia, Rahima Moosa Mother and Child Hospital and University of the Witwatersrand, Johannesburg; Grace M. Aldrovandi, UCLA; Rohan Hazra, Eunice Kennedy Shriver National Institute of Child Health and Human Development; and Caroline Tiemessen, National Institute for Communicable Diseases, National Health Laboratory Services, and Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

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Health should not be a privilege for the rich — UNAIDS

Gaps in public financing for health can be met by eliminating tax dodging and implementing progressive taxation; health and development must be protected from the growing impact of debt.

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UNAIDS is calling on governments to ensure that the right to health is realized by all by prioritizing public investments in health. At least half of the world’s population cannot access essential health services. Every two minutes a woman dies while giving birth. Among the people being left behind are women, adolescents, people living with HIV, gay men and other men who have sex with men, sex workers, people who inject drugs, transgender people, migrants, refugees and poor people.

“The right to health is eluding the poor and people trying to lift themselves out of poverty are being crushed by the unacceptably high costs of health care. The richest 1% benefit from cutting-edge science while the poor struggle to get even basic health care,” said Winnie Byanyima, Executive Director of UNAIDS.

Nearly 100 million people are pushed into extreme poverty (defined as living on US$ 1.90 or less a day) because they have to pay for health care, and more than 930 million people (around 12% of the world’s population) spend at least 10% of their household budgets on health care. In many countries, people are denied health care or receive poor quality health care because of unaffordable user fees. Stigma and discrimination denies poor and vulnerable people, especially women, their right to health.

Every week, 6000 young women around the world become infected with HIV. In sub-Saharan Africa, four out of five new HIV infections among adolescents are among adolescent girls and AIDS-related illnesses are the biggest killer of women of reproductive age in the region. Despite significant progress in reducing AIDS-related deaths and new HIV infections, there were 1.7 million new HIV infections in 2018 and nearly 15 million people are still waiting to receive HIV treatment.

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“Publicly financed health care is the greatest equalizer in society,” said Ms Byanyima. “When health spending is cut or inadequate, it is poor people and people on the margins of society, especially women and girls, who lose their right to health first, and they have to bear the burden of caring for their families.”

Delivering health care for all is a political choice that too many governments are not making. Thailand has reduced mortality rates for children under the age of five years to 9.1 per 1000 live births, while in the United States of America the rate is 6.3 per 1000 live births, even though Thailand’s gross domestic product per capita is about one tenth of that of the United States. Thailand’s progress has been achieved through a publicly financed health-care system that entitles every Thai citizen essential health services at all life stages and leaves no one behind.

South Africa had just 90 people on antiretroviral therapy in 2000, but in 2019 had more than 5 million on HIV treatment. South Africa now has the largest HIV treatment programme in the world. Countries such as Canada, France, Kazakhstan and Portugal have strong publicly financed health systems, yet some other richer countries do not.

Health investments in many countries remain very low compared to their gross domestic product. The United Nations Conference on Trade and Development estimates that developing countries lose between US$ 150 billion and US$ 500 billion every year owing to corporate tax avoidance and profit shifting by big companies. If this lost money were invested in health, health expenditure could triple in low-income countries and could double in lower-middle-income countries. The race to the bottom on corporate tax cheats denies developing countries of much needed revenue and robs ordinary people of vital health services. The countries of the Economic Community of West African States lose an estimated US$ 9.6 billion each year to numerous tax incentives.

READ:  Determinants of employability of people living with HIV

“It is unacceptable that rich people and big companies are avoiding taxes and ordinary people are paying through their ill health,” said Ms Byanyima. “Big companies must pay their fair share of taxes, protect employee rights, provide equal pay for equal work and provide safe working conditions for all, especially women.”

Debt is posing a serious threat to Africa’s economy, health and development, resulting in big cuts in social spending to ensure debt repayment. According to the International Monetary Fund, as of April 2019 half of low-income countries in Africa were either in debt distress or at a high risk of being so. Beyond low-income countries, in Zambia there was a 27% drop in health-care investments and an increase of debt servicing by 790% between 2015 and 2018. Similar trends were seen in Kenya, where debt servicing increased by 176% and health investments declined by 9% between 2015 and 2018. “There is an urgent need to manage debt in ways that protects people’s health. That means ensuring new financing focuses on social investments, debt repayments being halted for a period if needed to allow economic recovery and debt restructuring under a coordinated mechanism to protect spending on HIV, health and development,” said Ms Byanyima.

A major factor of ill health is the denial of human rights. According to the World Bank, more than one billion women lack legal protection against domestic violence and close to 1.4 billion women lack legal protection against domestic economic violence. In at least 65 countries, a same-sex sexual relationship is a crime. In recent years in some countries, crackdowns and restrictions on lesbian, gay, bisexual, transgender and intersex people have increased. Sex work is a criminal offence in 98 countries. Forty-eight countries and territories still maintain some form of HIV-related restrictions on entry, stay and residence. A recent study of sex work policies in 27 countries concluded that those that decriminalized some aspects of sex work have significantly lower HIV prevalence among sex workers.

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In 91 countries, adolescents require the consent of their parents to take an HIV test and in 77 countries they require the consent of their parents to access sexual and reproductive health services, creating barriers to protect young people from HIV infection. One of the consequences of this is that the HIV incidence rate among young women and girls in eastern and southern Africa is twice that of their male peers.

“In the next decade, we can end AIDS as a public health threat and achieve universal health coverage. Governments must tax fairly, provide publicly funded quality health care, guarantee human rights and achieve gender equality for all—it is possible,” said Ms Byanyima.

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Truvada should remain first choice for HIV prevention, experts say

With the exorbitant cost of these drugs, there are huge public health and economic implications if most PrEP users begin to use the newer TAF/FTC pill rather than TDF/FTC for PrEP.

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In October 2019, the US Food and Drug Administration approved a second medication for use as HIV preexposure prophylaxis, also known as PrEP, sparking controversy about which drug should be prescribed. Gilead Sciences, which manufactures both approved drugs, has argued that the new drug is safer and more effective than the old drug. But these claims are overstated, say a team of clinical and public health experts.

Their commentary, “Tenofovir Alafenamide for HIV Preexposure Prophylaxis – What Can We DISCOVER About Its True Value?”, appears in the January 14 issue of Annals of Internal Medicine.

PrEP, which is 99% effective in preventing HIV, exists in two forms: tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) – best known as Truvada, its brand name in the US – and tenofovir alafenamide with emtricitabine (TAF/FTC), known as Descovy. TDF/FTC has been used for PrEP for more than 7 years, with ample evidence of its safety and effectiveness.

“These drugs are equally effective when used for PrEP in gay and bisexual men and transgender women, and the potential safety benefits of TAF/FTC over TDF/FTC have not yet been shown to be clinically significant,” said lead author Douglas Krakower, MD, Assistant Professor at the Harvard Pilgrim Health Care Institute, Beth Israel Deaconess Medical Center, and Harvard Medical School.

The high cost of PrEP medications, around $24,000 per year in the US, has been a major barrier to PrEP use. Activists have argued that taxpayer money funded the development of PrEP medications, and the US Department of Health and Human Services recently sued Gilead Sciences over patent infringement.

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The older PrEP medication, TDF/FTC, will be available as a generic as early as 2020, which could reduce costs and increase access. But Gilead Sciences holds the exclusive rights to manufacture TAF/FTC until 2022 and has requested a patent extension to 2025. If the generic version of TDF/FTC is perceived to be less safe, uptake of TAF/FTC would presumably rise – with cost ramifications.

“With the exorbitant cost of these drugs, there are huge public health and economic implications if most PrEP users begin to use the newer TAF/FTC pill rather than TDF/FTC for PrEP,” said senior author Julia Marcus, PhD, Assistant Professor in the Department of Population Medicine at Harvard Pilgrim Health Care Institute and Harvard Medical School. “Gilead is asking us to ‘update’ our PrEP to TAF/FTC, but that’s not a clinically necessary or cost-effective choice for the vast majority of PrEP users.”

The authors examined the available data on the safety, efficacy, and public health context for the two PrEP medications. Robust data show the effectiveness of TDF/FTC in all priority populations at risk for HIV, including gay and bisexual men, transgender women, people who inject drugs, and heterosexuals whose partners are living with HIV. In contrast, the only efficacy data for TAF/FTC come from the DISCOVER trial, which enrolled solely gay and bisexual men and a small number of transgender women.

“In the DISCOVER study, TDF/FTC was associated with small changes in renal and bone biomarkers, while TAF/FTC was linked to weight gain and changes in cholesterol,” noted Dr. Krakower. But there were no differences between the groups in clinical events or the number of people who stopped the drug for safety reasons, suggesting that these small changes may not be clinically important. “Given the available clinical evidence and public health context, TDF/FTC should remain the first choice for the vast majority of PrEP users,” he said.

READ:  Study stresses negligible risk of transmitting HIV during sex when viral load is suppressed

In addition to Drs. Krakower and Marcus, authors of the commentary included Demetre Daskalakis, MD, Deputy Commissioner at the New York City Department of Health and Mental Hygiene, and Judith Feinberg, MD, Professor of Medicine at West Virginia University and Chair of the Board of Directors of the HIV Medicine Association.

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Phl reported 36 new HIV cases per day as of end-August 2019

In August 2019, there were 1,228 newly confirmed HIV-positive individuals reported to the HIV/AIDS & ART Registry of the Philippines. This was 17% higher compared with the diagnosed cases (1,047) in the same period in 2018.

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In August 2019, there were 1,228 newly confirmed HIV-positive individuals reported to the HIV/AIDS & ART Registry of the Philippines (HARP). This was 17% higher compared with the diagnosed cases (1,047) in the same period in 2018.

This is worth noting: The figure is ALSO higher than the month before, July 2019, when the HARP recorded 35 new HIV cases per day.

As of end-August, the Philippines now has 36 new HIV cases per day; up one case in July 2019.

As contained in the still-delayed report of the DOH, 15% of the new cases in August (or 185) had clinical manifestations of advanced HIV infection (WHO clinical stage 3 or 4) at the time of diagnosis.

Ninety-five percent (1,170) of the newly diagnosed were male. The median age was 27 years old (age range: 1-72 years old). Almost half of the cases (47%, 578) were 25-34 years old and 35% (424) were 15-24 years old at the time of testing.

More than a third (34%, 417) were from the National Capital Region (NCR). Region 4A (18%, 218), Region 3 (9%, 117), Region 7 (8%, 93), and Region 6 (7%, 82) comprised the top five regions with the most number of newly diagnosed cases for the month, together accounting for 76% of the total figure.

Sexual contact remained as the predominant mode of transmission (98%, 1,202). Among the newly diagnosed, 61% (748) reported transmission through male to male sex, 25% (310) through sex with both males and females, and 12% (144) were through male to female sex. Other modes of transmission were sharing of infected needles (1%, 13) and vertical (formerly mother-to-child) transmission (<1%, 2). Eleven cases had no data on mode of transmission.

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Among the newly diagnosed females this month, nine were pregnant at the time of diagnosis. Five cases were from NCR, two from Region 7 and one case each from Regions 3 and 11.

SPECIAL POPULATIONS

HIV continues to greatly adversely affect the young.

In August 2019, 424 (35%) cases were among youth 15-24 years old; and 97% were male. Almost all were infected through sexual contact (29 male-female sex, 288 male-male sex, 105 sex with both males and females). One case was infected through sharing of needles and one had no data on mode of transmission.

Still for the same period, there were 69 newly diagnosed adolescents (10-19 years old) at the time of diagnosis. Of these, two cases were 10-14 years old, 18 were 15-17 years old, and 49 were 18-19 years old. Almost all were infected through sexual contact (four male-female sex, 48 male-male sex, and 16 had sex with both males and females) and one had no data on mode of transmission. In addition, there were two diagnosed cases less than 10 years old and both were infected through vertical/mother-to-child transmission.

Sixty-three Filipinos who worked overseas within the past five years, whether on land or at sea, were diagnosed in August 2019. They comprised 5% of the total newly diagnosed cases for the month. Of these, 86% (54) were male. All were infected through sexual contact (seven male-female sex, 30 male-male sex, and 17 sex with both males and females). The ages of male OFWs ranged from 21 to 68 years (median: 32 years). Four were 15-24 years old, 27 were 25-34 years old, 22 were 35-49 years old, and one case was 50 years & older. Among the nine female OFWs diagnosed in August 2019, four each were in 25-34 & 35-49 years old age group and one was 50 years and older at the time of testing. The age range among diagnosed female OFWs were 31 to 56 years (median: 35 years old).

The number of those getting infected with HIV from transactional sex is still noteworthy.

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In August 2019, 13% (163) of the newly diagnosed engaged in transactional sex. Ninety-eight percent (159) were male and aged from 13 to 72 years old (median: 28 years). Fifty-eight percent (92) of the males reported paying for sex only, 35% (56) reported accepting payment for sex only and 7% (11) engaged in both. Also, among the four female cases who engaged in transactional sex, two were reported to have accepted payment for sex only, one case was paying for sex only and one case had engaged in both paying and accepting payment in exchange for sex.

Meanwhile, and as already stated, nine pregnant women were newly diagnosed with HIV. Five cases were from NCR, two from Region 7 and one case each from Regions 3 and 11. The age of diagnosis ranged from 19 to 36 (median age: 31).

ACCESS TO MEDS

The number of those in ART has FINALLY breached half the total number of PLHIVs.

The first case of HIV infection in the Philippines was reported in 1984. Since then, there have been 70,740 confirmed HIV cases reported to the HARP.

In August 2019, there were 922 patients who were initiated on ART. The median CD4 of these patients upon enrollment was 207 cells/mm. With the 922, a total of 40,952 people living with HIV (PLHIV) were presently on ART as of end-August. Most of whom were males (97%). The age of reported cases ranged from 1 to 81 years (median: 31 years old). Ninety-five percent were on first line regimen, 4% were on second line, and 1% were on other line of regimen.

READ:  924 new HIV cases reported in April 2018; 98% from unsafe sex

Still also worth noting is the continuing problem with access to treatment in the Philippines. The DOH itself has been lambasted for its problematic procurement issues that affect ART intake; and this is even if DOH continues to deny that there are issues hounding its HIV-related efforts.

COUNTING DEATHS

But that HIV is no longer a death sentence remains an invalid claim in the Philippines.

In August 2019, there were 70 reported AIDS-related deaths. Ninety-six percent (67) were males. One (1%) were less than 15 years old at the time of death, 16 (23%) cases were 15-24 years old, 30 (43%) were 25-34 years old, 19 (27%) were 35-49 years old and four (6%) were 50 years and older. Eighty-nine percent of the cases were reported to have acquired the infection through sexual contact.

Sexual contact (96%) was the most common mode of HIV transmission among reported deaths (752 through male-female sex, 1,698 through male-male sex, 987 through males who have sex with both males and females). Other modes of transmission of reported deaths were sharing of infected needles (79), vertical/mother-to-child transmission (26),

To stress, the actual number of AIDS-related deaths in the country is questionable because of non- and/or under-reporting.

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Pregnant women with HIV often not given recommended treatment

A study involving more than 1,500 women found that 30% were prescribed drugs that had insufficient evidence of safety in pregnancy.

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Women living with HIV who are also pregnant don’t always receive recommended antiretroviral medications, according to a recent study of prescribing patterns carried out by a MassGeneral Hospital for Children (MGHfC) researcher in collaboration with other members of the Surveillance Monitoring for ART Toxicities (SMARTT) study of the Pediatric HIV/AIDS Cohort Study (PHACS) network.

Few studies, if any, have compared actual prescribing patterns of HIV medications for pregnant women to national treatment guidelines. This study suggests that physicians may be prescribing ahead of the published recommendations, and using drugs or drug combinations they have seen work in the adult population in general.

“We studied, more than 1,500 women and found that 30% were prescribed drugs that had insufficient evidence of safety in pregnancy,” says Kathleen M. Powis, MD, MPH, investigator in MGHfC’s division of Pediatric Global Health and first author of the study, which was published in JAMA Network Open.

For the last 25 years, the US Department of Health and Human services Panel on Treatment of HIV-infected Pregnant Women and Prevention of Perinatal Transmission has published Perinatal HIV Treatment Guidelines on prescribing antiretroviral medications (ARVs) during pregnancy. In 1994, the guidelines just addressed the use of zidovudine, then the only drug approved to treat HIV infection. But by 2008 the prescribing guidelines for pregnant women were updated to recommend the use of triple ARVs, regardless of the woman’s HIV disease status. Pregnant women are typically excluded from studies testing newer drugs until safety has been established in nonpregnant adults. As a result, this data is usually some of the last to be collected.

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“The guidelines change nearly annually,” says Powis, who is also an assistant professor of Pediatrics at Harvard Medical School (HMS). “And a lot of the treatments that doctors are already using simply had ‘insufficient data’ to recommend their use in pregnant women. But doctors were prescribing them anyway.”

Since many of these regimens (70%) were eventually recommended for pregnant women, Powis suggests that doctors may be prescribing “ahead of time.” That is, they are seeing promising therapeutic results in the general population, and prescribing HIV drug treatment combinations to pregnant women based on that experience, rather than on guidelines.

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Even with early treatment, HIV still attacks young brains, says MSU study

While early antiretroviral therapy, or ART, has ensured less deadly outcomes for children living with and exposed to HIV, studies show the virus still may affect the brain. HIV may disrupt neurodevelopment, affecting how children learn, reason and function.

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While early antiretroviral therapy, or ART, has ensured less deadly outcomes for children living with and exposed to HIV, studies show the virus still may affect the brain. HIV may disrupt neurodevelopment, affecting how children learn, reason and function.

That’s why Michael Boivin, professor and director of the Psychiatry Research Program in the Michigan State University College of Osteopathic Medicine, set out to understand exactly how HIV impacts children’s neuropsychological development in a two-year longitudinal study, published in Clinical Infectious Diseases.

The research was supported in part by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

Boivin and his colleagues evaluated the neuropsychological development of three groups of children aged 5 to 11: those who acquired HIV perinatally and were treated with ART, those exposed but HIV-negative, and those who were never exposed. The research took place at six study sites across four countries in sub-Saharan Africa for a robust view of how HIV is affecting children in the region.

To date, it’s the first well-validated, multi-site neuropsychological evaluation of African school-aged children affected by HIV.

What the researchers discovered through various assessments was that even in the face of early treatment and good clinical care, there are still significant neuropsychological problems for children living with HIV.

“These children came into the study with a deficit compared to their counterparts,” Boivin said. “It stayed about the same throughout the two years, except in one important area: reasoning and planning. On that specific test domain, the children living with HIV failed to progress over time.”

READ:  Determinants of employability of people living with HIV

In other words, the gap between infected and HIV-negative children grew in the planning and reasoning area over the study period. Typically, these abilities tend to blossom in the school-aged years in healthy children.

“This is the most important cognitive function for the future of children living with HIV in terms of their likelihood of taking their medications, making good decisions, abstaining from risky behaviors like early sexual activity, psychosocial issues and school-related achievement,” Boivin said.

The bottom line? Early medical treatment, started as early as 6 months of age, is probably not enough to address the neurocognitive deficits associated with HIV, even though it helps keep children alive and healthier than they would be without treatment. In these children, treatment should be started even earlier to improve long-term neurocognitive outcomes.

“We’re going to have to complement the long-term care and support with actual behavioral interventions,” Boivin said.

That’s something Boivin and his colleagues are already working on. Earlier this year, Boivin received a 5-year, $3.2 million NIH grant to continue his work with children affected by HIV in Uganda and Malawi.

Through this grant, researchers will investigate how MSU-developed computer cognitive games can serve as tools for neurocognitive evaluation, enrichment and potentially rehabilitation.

Boivin hopes that the results of both of these studies will help make this model of neuropsychological evaluation a considered part of the cost benefit of care for kids affected by HIV.

“Often it’s overlooked or seen as an afterthought, but unlike other areas of medical follow up, neuropsychological evaluation really gets at how well the kids are going to adapt and function in school, at home, in the community and in society in general,” Boivin said. “It’s really what links us most directly to the human burden of disease.”

READ:  Erectile dysfunction and living with HIV

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