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Time is running out to reach the 2020 HIV targets – UNAIDS

New HIV infections are rising in around 50 countries, AIDS-related deaths are not falling fast enough and flat resources are threatening success. Half of all new HIV infections are among key populations and their partners, who are still not getting the services they need.



UNAIDS is issuing countries with a stark wake-up call. In a new report, UNAIDS warns that the global response to HIV is at a precarious point. At the halfway point to the 2020 targets, the report, Miles to go—closing gaps, breaking barriers, righting injustices, warns that the pace of progress is not matching global ambition. It calls for immediate action to put the world on course to reach critical 2020 targets.

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“We are sounding the alarm,” said Michel Sidibé, executive director of UNAIDS. “Entire regions are falling behind, the huge gains we made for children are not being sustained, women are still most affected, resources are still not matching political commitments and key populations continue to be ignored. All these elements are halting progress and urgently need to be addressed head-on.”

HIV prevention crisis

Global new HIV infections have declined by just 18% in the past seven years, from 2.2 million in 2010 to 1.8 million in 2017. Although this is nearly half the number of new infections compared to the peak in 1996 (3.4 million), the decline is not quick enough to reach the target of fewer than 500 000 by 2020.
The reduction in new HIV infections has been strongest in the region most affected by HIV, eastern and southern Africa, where new HIV infections have been reduced by 30% since 2010. However, new HIV infections are rising in around 50 countries. In eastern Europe and central Asia the annual number of new HIV infections has doubled, and new HIV infections have increased by more than a quarter in the Middle East and North Africa over the past 20 years.

Treatment scale-up should not be taken for granted

Due to the impact of antiretroviral therapy roll-out, the number of AIDS-related deaths is the lowest this century (940 000), having dropped below 1 million for the first time in 2016. Yet, the current pace of decline is not fast enough to reach the 2020 target of fewer than 500 000 AIDS-related deaths.
In just one year, an additional 2.3 million people were newly accessing treatment. This is the largest annual increase to date, bringing the total number of people on treatment to 21.7 million. Almost 60% of the 36.9 million people living with HIV were on treatment in 2017, an important achievement, but to reach the 30 million target there needs to be an annual increase of 2.8 million people, and there are indications that the rate of scale-up is slowing down.

West and central Africa lagging behind

Just 26% of children and 41% of adults living with HIV had access to treatment in western and central Africa in 2017, compared to 59% of children and 66% of adults in eastern and southern Africa. Since 2010, AIDS-related deaths have fallen by 24% in western and central Africa, compared to a 42% decline in eastern and southern Africa.

Nigeria has more than half (51%) of the HIV burden in the region and there has been little progress in reducing new HIV infections in recent years. New HIV infections declined by only 5% (9000) in seven years (from 179 000 to 170 000) and only one in three people living with HIV is on treatment (33%), although HIV treatment coverage has increased from just 24% two years ago.

Progress for children has slowed

The report shows that the gains made for children are not being sustained. New HIV infections among children have declined by only 8% in the past two years, only half (52%) of all children living with HIV are getting treatment and 110 000 children died of AIDS-related illnesses in 2017. Although 80% of pregnant women living with HIV had access to antiretroviral medicines to prevent transmission of HIV to their child in 2017, an unacceptable 180 000 children acquired HIV during birth or breastfeeding—far away from the target of fewer than 40 000 by the end of 2018.

“One child becoming infected with HIV or one child dying of AIDS is one too many,” said Mr Sidibé. “Ending the AIDS epidemic is not a foregone conclusion and the world needs to heed this wake-up call and kick-start an acceleration plan to reach the targets.”

Key populations account for almost half of all new HIV infections worldwide

The report also shows that key populations are not being considered enough in HIV programming. Key populations and their sexual partners account for 47% of new HIV infections worldwide and 97% of new HIV infections in eastern Europe and central Asia, where one third of new HIV infections are among people who inject drugs.

“The right to health for all is non-negotiable,” said Sidibé. “Sex workers, gay men and other men who have sex with men, prisoners, migrants, refugees and transgender people are more affected by HIV but are still being left out from HIV programs. More investments are needed in reaching these key populations.”

Half of all sex workers in Eswatini, Lesotho, Malawi, South Africa and Zimbabwe are living with HIV. The risk of acquiring HIV is 13 times higher for female sex workers, 27 times higher among men who have sex with men, 23 times higher among people who inject drugs and 12 times higher for transgender women.

“Communities are echoing UNAIDS’ call,” said Vincent Pelletier, positive leader and executive director of Coalition PLUS. “We need universal access to adapted prevention services, and protection from discrimination. We call upon world leaders to match commitments with funding, in both donor and implementing countries.”

Stigma and discrimination persists

Discrimination by health-care workers, law enforcement, teachers, employers, parents, religious leaders and community members is preventing young people, people living with HIV and key populations from accessing HIV prevention, treatment and other sexual and reproductive health services.

Across 19 countries, one in five people living with HIV responding to surveys reported being denied health care and one in five people living with HIV avoided visiting a health facility for fear of stigma or discrimination related to their HIV status. In five of 13 countries with available data, more than 40% of people said they think that children living with HIV should not be able to attend school with children who are HIV-negative.

New agenda needed to stop violence against women

In 2017, around 58% of all new HIV infections among adults more than 15 years old were among women and 6600 young women between the ages of 15 and 24 years became infected with HIV every week. Increased vulnerability to HIV has been linked to violence. More than one in three women worldwide have experienced physical or sexual violence, often at the hands of their intimate partners.

“Inequality, a lack of empowerment and violence against women are human rights violations and are continuing to fuel new HIV infections,” said Sidibé. “We must not let up in our efforts to address and root out harassment, abuse and violence, whether at home, in the community or in the workplace.”

90–90–90 can and must be achieved

There has been progress towards the 90–90–90 targets. Three quarters (75%) of all people living with HIV now know their HIV status; of the people who know their status, 79% were accessing treatment in 2017, and of the people accessing treatment, 81% had suppressed viral loads.

Six countries, Botswana, Cambodia, Denmark, Eswatini, Namibia and the Netherlands, have already reached the 90–90–90 targets and seven more countries are on track. The largest gap is in the first 90; in western and central Africa, for example, only 48% of people living with HIV know their status.

A big year for the response to tuberculosis

There have been gains in treating and diagnosing HIV among people with tuberculosis (TB)—around nine out of 10 people with TB who are diagnosed with HIV are on treatment. However, TB is still the biggest killer of people living with HIV and three out of five people starting HIV treatment are not screened, tested or treated for TB. The United Nations High-Level Meeting on Tuberculosis in September 2018 is an opportunity to bolster momentum around reaching the TB/HIV targets.

The cost of inaction

Around US$ 20.6 billion was available for the AIDS response in 2017—a rise of 8% since 2016 and 80% of the 2020 target set by the United Nations General Assembly. However, there were no significant new commitments and as a result the one-year rise in resources is unlikely to continue. Achieving the 2020 targets will only be possible if investments from both donor and domestic sources increase.

Ways forward

From townships in southern Africa to remote villages in the Amazon to mega-cities in Asia, the dozens of innovations contained within the pages of the report show that collaboration between health systems and individual communities can successfully reduce stigma and discrimination and deliver services to the vast majority of the people who need them the most.

These approaches continue to drive the solutions needed to achieve the 2020 targets. When combination HIV prevention—including condoms and voluntary medical male circumcision—is pursued at scale, population-level declines in new HIV infections are achieved. Oral pre-exposure prophylaxis (PrEP) is having an impact, particularly among key populations. Offering HIV testing and counseling to family members and the sexual partners of people diagnosed with HIV has significantly improved testing access.

Eastern and southern Africa has seen significant domestic and international investments coupled with strong political commitment and community engagement and is showing significant progress in achieving the 2020 targets.

“For every challenge there is a solution,” said Sidibé. “It is the responsibility of political leaders, national governments and the international community to make sufficient financial investments and establish the legal and policy environments needed to bring the work of innovators to the global scale. Doing so will create the momentum needed to reach the targets by 2020.”


Researchers find diverse supportive partnerships among older gay men with and without HIV

Along with successful HIV treatments, it is known that the presence of social support impacts long-term survival among men living with HIV. However, little has been known about the types of supportive relationship among gay men in general, and none for those men living with HIV.



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Recent data reveals that gay men living with HIV report having supportive relationships with family, friends, or in informal relationships rather than with primary romantic partners, while gay men who are HIV negative report having relationships mainly with primary partners. Additionally, gay men living with HIV were more likely to report no primary or secondary supportive partnerships compared to men who are HIV negative.

The analysis was led by researchers at Georgetown University Medical Center. The finding appears in PLOS ONE.

Along with successful HIV treatments, it is known that the presence of social support impacts long-term survival among men living with HIV. However, little has been known about the types of supportive relationship among gay men in general, and none for those men living with HIV. Identifying the types of relationships could inform how they impact healthy aging among this community of men.

To fill this knowledge gap, Georgetown researchers conducted a study to identify the types of supportive relationships among middle-aged and older gay men living with and without HIV.

The average age of the men was 62, with similar numbers of HIV positive and negative men. The study participants were asked about any primary or secondary supportive relationships in their life. A primary relationship was defined as a long-term relationship that included marriage, other forms of legal commitment, or a strong romantic commitment between partners. Secondary relationships included close friends, biological family members, chosen family sexual partners, or former romantic partners.

“We recognized that little was known about the types of supportive relationships these men had — whether they were in committed romantic relationships, or if they relied on other non-romantic partnerships, such as family and friends,” said lead author Matthew Statz.

The large number of older gay men, regardless of their HIV status, who reported having neither a primary nor secondary supportive relationship was unexpected and concerning, according to Statz, adding that the importance of social support has been clearly established in the management of chronic illness, including HIV.

Statz says the study paves the way for further research into how these men’s partnerships impact all aspects of their mental and physical health, including implications for HIV viral suppression, frailty and loneliness.

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Self-testing trebles HIV testing rate among trans people

Despite increased vulnerability for trans people, they are seldom included in HIV testing or prevention research, and when they are their data is rarely presented separately from other priority groups such as gay and bisexual men.



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HIV self-testing could reduce the time between HIV infection and HIV diagnosis amongst trans people when compared to standard testing services, suggests new research in EClinicalMedicine.

The project was a collaboration between the London School of Hygiene & Tropical Medicine (LSHTM), University College London (UCL), and the Medical Research Council Clinical Trials Unit. It involved more than 100 trans men and trans women in England and Wales, and is the largest HIV self-testing trial in this community to be reported.

Participants were first randomised into two groups, one was given one self-test for HIV, the other group was offered a link to find standard testing services, and no self-tests. Some of the self-testing arm were randomised a second time and offered either repeat self-testing (an additional self-test every three months) or standard testing services. They were then followed up for two years.

More than 93% of participants in the self-testing group tested for HIV compared to 26% in the standard care group. HIV testing frequency was also increased by three times in the repeat testing group. Importantly there were no negative impacts on STI testing, but uptake of these services was very low across all arms in the trial.

Accompanying qualitative research led by the London School of Hygiene & Tropical Medicine revealed that the main reason HIV self-testing was so popular was because most sexual health services do not meet the needs of trans people. Services were reported to be often set-up and run in a way that did not recognise their unique needs.

Trans people are at increased risk of HIV and poor sexual health compared to other groups. They tend to test less often and have worse clinical outcomes when they are diagnosed with HIV.

The researchers say rolling out self-testing more widely and making sure it is accessible to trans people will increase HIV testing rates, and that staff require training aimed at improving the experiences of trans people when they access sexual health services.

Charles Witzel from LSHTM who led the qualitative study, said: “HIV has changed enormously. Thanks to effective treatment people with HIV can now live long and full lives. However, stigma and inappropriately designed services still act as a major barrier for individuals to access testing, the critical first step towards treatment for those with undiagnosed HIV and an important prevention opportunity for those who are HIV negative.

“Despite increased vulnerability for trans people, they are seldom included in HIV testing or prevention research, and when they are their data is rarely presented separately from other priority groups such as gay and bisexual men. Our research aimed to shed new light on how best to meet the HIV testing needs of trans men and trans women.”

HIV self-testing was legalised in the UK in 2014 but has not been made widely available on the NHS. Instead, self-testing has mostly been provided in fits and starts through pilot projects run by the voluntary sector and through a large clinical trial in England and Wales.

An HIV Self-testing Public Health Intervention (SELPHI) study was a large randomised trial of HIV self-testing in England and Wales which recruited men (cis and trans) and trans women, all who have sex with men.

The trial assessed whether providing free self-testing would increase HIV testing uptake and frequency, and if it had any impacts on STI testing.

Acceptability of the HIV self-test kit was very high: 97% found the instructions easy to understand, 97% found the test easy to use and 100% reported a good overall experience.

The qualitative peer-interview study sourced additional insights of the experiences of trans people when accessing HIV testing services, including HIV self-testing. It found staff working in sexual health clinics frequently misgendered them or provided stigmatising care which wasn’t respectful of their gender identity and/or their sexual orientation.

However, participants who had accessed sexual health services specifically designed for and by trans people said that these services were excellent.

Alison Rodger from UCL who co-led the trial said: “Put together, the results of our study clearly show the potential HIV self-testing has to meet some of the immediate HIV testing needs for trans men and trans women. This could mean more people with HIV receive treatment earlier which will have benefits for their health and will also reduce onward transmissions.”

Talen Wright, a peer researcher who worked on the study said. “It is critical that sexual health clinics adapt to be more inclusive, welcoming and to make sure they meet the diverse needs of these groups. Trans people must be actively included in these initiatives to make them successful.”

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Phl ends 2020 with 22 new HIV cases per day

The government figures may not show the real situation because HIV-related services – including testing – have been affected by Covid-19.



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The other pandemic.

HIV is still a major issue in the Philippines, with 22 Filipinos getting infected with the virus every day, at least as of December 2020 as reported to the HIV/AIDS & ART Registry of the Philippines (HARP) of the Department of Health (DOH).

The number is actually lower than 2019’s 35 new HIV cases per day. However, the new number may not represent the real HIV situation of the country since HIV-related services have been affected by Covid-19.

According to HARP, in December 2020, there were 1,076 confirmed HIV-positive individuals. Eighteen percent (198) had clinical manifestations of advanced HIV infection at the time of testing.

Ninety-five percent (1,017) of the reported cases were male, with a median age of 28 years old (age range: 2-74 years old). More than half of the cases (54%, 579) were 25-34 years old, and 25% (273) were 15-24 years old at the time of diagnosis.

More than a quarter (28%, 300) were from the National Capital Region (NCR). Region 7 (26%, 281), Region 4A (13%, 136), Region 3 (8%, 90), and Region 1 (6%, 68) comprised the top five regions with the most number of newly reported cases for this reporting period, together accounting for 81% of the total cases.

Sexual contact remained as the predominant mode of transmission (92%, 985). Among the newly reported cases acquired HIV through sexual contact, 62% (613) were through male to male sex, 24% (236) through males who have sex with both males and females, and 14% (136) through male to female sex. Further, 47 (4%) were infected through sharing of needles and three cases (<1%) were infected through mother-to-child transmission. Forty-one cases (4%) had no data on mode of transmission.


273 (25%) cases were among youth 15-24 years old, and 94% were male. Ninety-seven percent (264) were infected through sexual contact (29 male-female sex, 182 male-male sex, 53 sex with both males and females), and four (1%) were infected through sharing of needles. Five (2%) cases had no data on the MOT.

There were 37 newly-reported adolescents with HIV. Of these, 3% (1) were 10-14 years old, 21% (8) were 15-17 years old, and 76% (28) were 18-19 years old. All adolescents were infected through sexual contact (7 male-female sex, 23 male-male sex, 7 sex with both males and females).

Further, five children were diagnosed with HIV in this reporting period. Three were infected through vertical (nee mother-to-child) transmission, while two had no data on MOT.


In December 2020, 13 cases were reported pregnant at the time of diagnosis. Eight cases were from Region 7, four cases from NCR, and one case from Region 3.

Reporting of pregnancy status at the time of diagnosis was included in the HARP only starting 2011.

From January to December 2020, there were 105 HIV positive women reported pregnant at the time of diagnosis. Of these, 35% (37) were from NCR, 19% (20) were from Region 4A, 16% (17) were from Region 3 and 30% (31) were from the rest of the country. The age of diagnosis ranged from 15 to 45 years old (median age: 25).


In December 2020, 11% (118) of the newly-diagnosed engaged in transactional sex. All were male and aged from 15 to 56 years old (median: 30 years old). Fifty- eight percent (68) of the males reported paying for sex only, 27% (32) reported accepting payment for sex only, and 15% (18) engaged in both.

People who engage in transactional sex are those who reported that they either pay for sex, regularly accept payment for sex, or do both. Reporting of transactional sex was included in the HARP only starting December 2012.


In December 2020, there were 639 people with HIV who were initiated on ART. The median CD4 count of these patients upon enrollment was 195 cells/mm .

By end-2020, a total of 47,977 PLHIV were on ART. Most (96%) were males. The age of reported cases ranged from 1 to 82 years (median: 32 years old). Ninety-five percent were on first line regimen, 4% were on second line, and 1% were on other line of regimen.


Highlighting that HIV still kills in the Philippines, in December 2020, there were 51 reported deaths due to any cause among people with HIV. Ninety-eight percent (50) were males. Five (10%) cases were 15-24 years old, 25 (49%) were 25-34 years old, 19 (37%) were 35-49 years old and 2 (4%) were 50 years and older.

Most (92%, 47) of those who died were reported to have acquired HIV through sexual contact (7 through sex with male and female, 24 through male-male sex, and 16 through sex with both males and females), and 8% (4) through sharing of infected needles.

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USC study measures brain volume differences in people with HIV

Brain scans of more than 1,200 HIV-infected adults across 5 continents show smaller volumes associated with lower white blood cell counts.



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Nearly 38 million people around the world are living with HIV, which, with access to treatment, has become a lifelong chronic condition. Understanding how infection changes the brain, especially in the context of aging, is increasingly important for improving both treatment and quality of life.

Researchers at the Mark and Mary Stevens Neuroimaging and Informatics Institute (USC Stevens INI), part of the Keck School of Medicine of USC, and other international NeuroHIV researchers, published one of the largest-ever neuroimaging studies of HIV. The researchers pooled magnetic resonance imaging (MRI) data from 1,203 HIV-positive individuals across Africa, Asia, Australia, Europe and North America. Their findings were published in JAMA Network Open, an open-access journal from the American Medical Association.

“Brain injury caused by HIV can lead to cognitive challenges, even in those receiving treatment,” says Talia Nir, PhD, a postdoctoral scholar at the USC Stevens INI’s Laboratory of Brain eScience (LoBeS) and first author of the study. “Establishing a common pattern of effects on the brain across different populations is a key step toward addressing those issues. The strength of this large dataset is that it is more representative of an era where treatment for HIV infection is widely available.”

The researchers looked at the link between blood plasma, which is routinely collected to monitor immune function and treatment response, and the volume of various structures in the brain. Lower white blood cell counts generally indicate that the immune system is being suppressed. Here, they found, for example, that participants with lower white blood cell counts also had less brain volume in the hippocampus and thalamus, parts of the brain’s limbic system involved in regulating memory, emotion and behavior.

These findings are important because they were largely derived from brain scans of individuals undergoing antiretroviral therapy–and they indicate that people receiving such treatment may exhibit a different brain injury signature compared to untreated individuals, which earlier studies tended to focus on. They highlight deficits in brain areas that are also vulnerable to age-related neurodegenerative diseases.

Accelerated atrophy of the hippocampus, the region that showed the most consistent effects in the study, is a hallmark of neurodegenerative diseases such as Alzheimer’s disease. Common age and HIV-related pathological processes, such as inflammation and blood brain barrier impairment, may accelerate age-related neurodegenerative processes.

“There are many factors that contribute to brain tissue loss and subsequent cognitive impairments as we age, and a person’s immune function is no exception,” says Neda Jahanshad, PhD, associate professor of neurology at the INI and one of the senior authors of the study. “Through these large-scale efforts, we’re beginning to understand the link between immune function and brain alterations in individuals living, and aging, with HIV.”

The analysis was a product of the Enhancing Neuro Imaging Genetics through Meta-Analysis (ENIGMA) consortium’s HIV Working Group, established by Jahanshad and colleagues in 2013 to pool harmonized data across neuroimaging studies. The ENIGMA network at large, led by the institute’s associate director, Paul M. Thompson, PhD, unites neuroimaging researchers in 45 countries to study psychiatric disorders, neurodegenerative diseases and other aspects of brain function. In addition to housing ENIGMA, the USC Stevens INI is a powerhouse of neuroimaging and related science, known for large cohort analyses of imaging, genetics, behavioral, clinical and other data. Investigators from 13 existing HIV studies in the United States, France, Serbia, Australia, Thailand and South Africa collaborated on the JAMA Network Open paper.

Next, the team will analyze imaging data over time, including diffusion imaging data, another type of MRI data that maps the brain’s white matter pathways, to further understand how clinical markers of HIV infection affect the brain and the rate of neurodegeneration. As part of that ongoing work, they are inviting researchers around the world to join the ENIGMA-HIV Working Group.

“With a greater collaborative effort, we hope to be able to assess how genetic, environmental, lifestyle and treatment-related factors may further impact neurological outcomes,” Nir says.

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Reforming harmful laws, policies essential to end AIDS by 2030 in APAC

New report provides update on trends in the region and outlines the problematic laws and policies that continue to impact people living with HIV and key populations.



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Reforming laws and policies to ensure they are grounded in evidence and human rights is essential for an effective HIV response in Asia and the Pacific, says a new joint report by UNAIDS and the United Nations Development Programme (UNDP).

In 2015, 193 United Nations Member States agreed on the 2030 Agenda for Sustainable Development. This included a goal of ending the AIDS epidemic by 2030 and leaving no one behind through a multisectoral, rights-based, people-centred approach that addresses the determinants of health. Yet, legal and policy obstacles continue to undermine an effective HIV response in the region – particularly among vulnerable populations – limiting access to prevention, testing, treatment and care services.

The new report, Legal and policy trends impacting people living with HIV and key populations in Asia and the Pacific 2014–2019, provides a summary of recent key developments and outlines laws and policies that are hindering the response in the region. 

There is a large body of international evidence demonstrating that decriminalization and introduction of protective and enabling laws and policies result in significant health benefits to key populations by reducing stigma and supporting improved access to health and HIV services. In contrast, punitive laws and policies increase vulnerability to HIV and act as major barriers to health services for the people who need them most.

“Overall, we’re seeing uneven progress in efforts to achieve enabling laws and policies for HIV responses among key populations at higher risk of HIV. In some countries in the region the trend is towards a harsher and more punitive environment,” said Eamonn Murphy, UNAIDS Regional Director for Asia and the Pacific. “We hope that the evidence laid out in this report will lead to the necessary reforms of harmful laws and policies – the structural barriers that are essential to ending AIDS by 2030.”

The report highlighted comprehensive HIV legislation introduced in India and the Philippines as models for other countries to follow. These laws address multiple aspects of the national HIV response in a single law, including legal frameworks for prevention, testing, treatment, discrimination, legal redress mechanisms, national leadership and coordination mechanisms.

There has also been positive progress with the legal recognition of transgender people in Pakistan, which is vital to combat stigma and ensure people can enjoy equal access to health services. Pakistan’s Transgender Persons Act, enacted in 2018, has enabled transgender persons to freely express their gender according to their gender identity, and have that choice reflected in their legal identity.

While progress has been made, there have also been major setbacks. For instance, there has been a resurgence of harsh laws and policies for drug control in some Asian countries, whereby governments continue to apply criminal punishments rather than public health approaches. The report found that approaches which include the use of punitive laws against people who use drugs, impede the implementation of effective HIV prevention measures.

Criminalization of consensual same-sex sexual conduct between men also continues to impede HIV responses by deterring access to HIV testing and treatment services. In Asia and the Pacific, many countries currently have laws that criminalize same-sex sexual relations. The report points to the decision by India’s Supreme Court to decriminalize same-sex relations in 2018 as a landmark ruling for the region and globally. In many other countries, however, the legal environment for gay men and other men who have sex with men remains hostile.

Sex work in most countries in the region remains prohibited. In some countries, however, sex work is quasi-legal and subject to official oversight, or other types of regulation. Some countries in the region have seen regression to punitive laws and law enforcement practices, forcing sex workers to go underground and increasing vulnerability to HIV, loss of access to health services, violence, stigma and discrimination. 

Moving forward, the report acknowledges, legislators and policy-makers in the region seeking to advance a human rights-based approach to HIV are facing a highly challenging context. Nonetheless, the report reaffirms the critical importance of enabling laws and policies if countries are to reach the goal of ending AIDS by 2030.

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FDA approves first long-acting HIV treatment

The FDA in the US approved CABENUVA as the first once-monthly, long-acting injectable (LAI) for the treatment of HIV-1 infection in adults. CABENUVA consists of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare Ltd.), for treating HIV-1 infection in adults.



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The FDA in the US approved CABENUVA as the first once-monthly, long-acting injectable (LAI) for the treatment of HIV-1 infection in adults. CABENUVA consists of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare Ltd.), for treating HIV-1 infection in adults.

Before proceeding with the news (and dampening the good news), here’s an FYI: As quoted by NBC News, ViiV Healthcare Ltd. stated that the shot combo would cost $5,940 for an initial, higher dose and $3,960 per month afterward.

According to the FDA, the safety and efficacy of CABENUVA were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with CABENUVA. The patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed (

In first trial, the ATLAS study, CABENUVA was said to have met the primary endpoint for noninferiority (or the proportion of participants with plasma HIV-1 RNA ≥50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ≥50 c/mL. Two percent of patients receiving the long-acting injectable and 1% of patients receiving CAR had an HIV-1 RNA level ≥50 c/mL at Week 48 (Treatment difference 0.7%; 95% CI: -1.2%, 2.5%).

In second trial, the FLAIR study, a comparable number of patients receiving either CABENUVA or daily oral dolutegravir/abacavir/lamivudine therapy had an HIV-1 RNA count ≥50 c/mL, meeting noninferiority criteria. Two percent of patients in both treatment arms had an HIV-1 RNA count ≥50 c/mL at Week 48 (Treatment difference -0.4%; 95% CI: -2.8%, 2.1%).

Rilpivirine and cabotegravir are able to act as a complete regimen for people with HIV, allowing it to replace the antiretroviral regimen for those who are virologically suppressed with HIV-1 RNA at less than 50 copies per milliliter [c/mL], have no history of treatment failure, and are not known or suspected to have any resistance to either cabotegravir or rilpivirine.

To administer the therapy, a provider would conduct a once-monthly administration that would consist of two individual intramuscular injections in the buttocks.

Added the FDA: The most common adverse reactions with CABENUVA were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter).

In a press release, Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson said: “With the approval of CABENUVA, we’re proud to bring a new treatment option to people living with HIV that removes the burden of taking a daily pill… While much more remains to be done to make HIV history, today’s milestone reminds us how far medical innovation has come since the first reported cases of the virus almost 40 years ago.”

Now, and realistically, with newer HIV medicines like rilpivirine and cabotegravir not even widely offered in countries like the Philippines yet, the even newer injectables may sound promising but remain stuff of dreams…

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