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Confessions of a former ‘gift’ giver…

Patrick King Pascual interviews Paolo, a Filipino living with HIV, who used to hang out with others who touted sharing the “gift”. “If I could only turn back time, I would not have done all those things,” Paolo now says. But he now also believes in one’s responsibility over oneself. “Even if you’re having a fun time, never let your guard down. You should never completely trust anyone when it comes to sex, especially when you are at your most gullible and vulnerable self.”

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This is part of “More than a Number”, which Outrage Magazine launched on March 1, 2013 to give a human face to those infected and affected by the Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) in the Philippines, what it considers as “an attempt to tell the stories of those whose lives have been touched by HIV and AIDS”. More information about (or – for that matter – to be included in) “More than a Number”, email editor@outragemag.com, or call (+63) 9287854244 and (+63) 9157972229.

(THIS IS PART OF A SERIES, WITH THE STORY OF PAOLO SHARED IN PARTS – ED)

“I felt a sudden jolt after I came/orgasmed inside the person that I was having sex with bareback,” Paolo said. He didn’t look particularly happy; he even had a blank stare.

But he was open about sharing his sexual experiences with me.

Particularly that part in his life, when he used to be a “participant of a small group of HIV-positive straight-acting gays who frequent different places in the metro and engage in different sexual activities.”

Paolo, by the way, was diagnosed with HIV in 2007. After he registered and submitted his medical documents in San Lazaro Hospital, he didn’t go back until early 2011.

LIVING LIFE TO THE FULLEST

“Maybe I’m the type who doesn’t dwell much on problems. I was aware that I will be battling a lifelong endeavor (being HIV-positive), but I didn’t want to think about it to the point that my life would be hindered,” he said.

When his boyfriend at the time broke up with him, right after he regained his strength from the ARV trial period he had to endure, he lived each day as if it was his last.

“I revealed my condition to some friends and they have been very supportive,” Paolo said. His friends were so supportive, in fact, that “we were going out almost every night.”

It was during one of those night outs that he met Red*.

Red is also HIV-positive; he was diagnosed a year later than Paolo. They became fast friends after their first meeting. “There was nothing sexual nor intimate between us. We were just really good friends,” said Paolo, who found solace in the company of Red.

READ:  42 Filipinos now infected with HIV daily; 1,249 new HIV cases reported in January

Partying for Paolo meant frequenting the likes of gay bars, including Bed Bar and O Bar. “I was living my life to the fullest; like I’m HIV-free,” Paolo said.

Bar-hopping – according to Paolo – also happened in the likes of Fahrenheit, Palawan, Blue Fairies, and others.

Though Paolo admitted that he was a regular in those establishments, for a while, he went there solely to party.  Picking up was not in his mind, as he was “still afraid and very cautious to have sex with another person. I was only doing oral sex that time.”

Soon, though, everything changed.

NEWFOUND INDEPENDENCE

As shared by Paolo, during one of their “crazy nights” in a bar in Quezon City, “Red and I met a group of good looking and gym-toned straight-acting gays. We had drinks at (this) bar. And after an hour of laughter, we left the club and went to (a bar) in Ortigas,” Paolo recalled.

The night went by like their “regular night outs”. They watched the performances, ordered several bottles of beer, and flirted with different people.

Little did Paolo know that he actually signed up for a different type of fun that night.

“I think it was around 3:00 AM and we were all very tipsy, when one of our newfound friends, Marvin*, started kissing someone he just met on the dance floor,” Paolo narrated. “And then he pulled me closer to them and started rubbing my crotch.”

Tara, sama ka sa amin (Come join us),” Paolo remembered Marvin saying with a smile.

The three of them left that bar and went to Marvin’s apartment.

“While I was getting head from the guy we picked up from the bar, Marvin positioned himself behind him. He started penetrating him without a condom,” Paolo recounted. “After several minutes, he held the bottom guy closer to him, holding his waist tightly, and shot his load.”

After their encounter, the guy they picked up just got dressed and then immediately left. And while Paolo was fixing himself, Marvin asked if he wanted to grab an early breakfast. He agreed.

READ:  What’s in a name?

Their conversation while eating turned from recounting what happened at Marvin’s apartment to being confrontational.

“’I saw what you took when we were at O Bar, and it wasn’t a party pill!’, Marvin told me. I was silent at first, and then he continued: “It’s okay, don’t worry, pareho lang tayo (we’re the same),” Paolo said.

SHARING “THE GIFT”

From then on, Paolo and Marvin’s group became this close-knit circle that frequented the bars, flirting and picking up random people, and inviting them to go with them for sex.

“It became my routine. I went to those places three to four times a week to meet different people. And I always performed unprotected sex with them. At that time, I thought I was satisfying my ego, that I had the upper hand and in control,” Paolo said, shaking his head.

He also thought “I was sharing the ‘gift’.”

It reached a point where he no longer joined Marvin’s group and just went out to party and pick up on his own.

“Last year was really the height of my inappropriate routine. As people flocked O Bar, for instance, my choices widened. Every time I went there, I always made it a point that I will be bringing someone home. It became very addicting,” he admitted.

And there were times that “after finishing someone, I would go back to bars to pick up someone again.”

Red*, who ended up knowing about Paolo’s “addiction”, tried talking him out of it.  Paolo just “refused to respond to his calls and text messages.”

TURNING POINT

Last March, according to Paolo, when he went to a bar in Ortigas, “I met this really cute guy. He was about the same height as I am, and he had a really good built,” Paolo said.

They shared drinks together and danced to several songs. And like usual, he invited this guy back to his place.

Paolo had unprotected sex with him. But unlike most of the his one-night encounters, this new guy chose to spend the night at his place.

“We had sex three times that night – at all times, I came inside him. The following day, he gave me a call saying that he wanted to have lunch with me,” Paolo recalled.

READ:  On using phased-out medication

They met and had lunch together. It was also then that he found out that this new guy really likes him.

“He also confessed to me that he was only 16 years old,” Paolo added.

Paolo paused and lit another cigarette. Suddenly, his phone rang; he excused himself.

He returned, looking apologetic.  “Sorry about that. It was the 16-year-old guy I was telling you about,” he said.  He lit another cigarette.

And then sitting across me again, he continued: “We started dating after that unfortunate night. I really like him. But at the same time I feel guilty. He is still young and I (may have given) him the disease. I was awakened. I wanted to die after learning that he was only 16 years old. I felt really sorry for myself… that I had to do those things.”

Paolo was misty-eyed while talking; he even rubbed his eye, looking more like wiping his tears. He cleared his throat, and then continued smoking, finishing his cigarette.

“I know that I’m a bad person because I did all those things and it took me a long time to realize that,” Paolo said. “If I could only turn back time, I would not have done all those things.”

He also added that if he would be given a chance, he would talk to all the people that he had unprotected sex with and ask for their forgiveness.

“Some people living with HIV do really go around to spread the ‘gift’,” Paolo said. There are those who “are out there victimizing HIV-negative members of the community.”

Being more aware, Paolo also believes in one’s responsibility over oneself – helped, obviously, with further education that empowers people to protect themselves.  “Even if you’re having a fun time, never let your guard down. You should never completely trust anyone when it comes to sex, especially when you are at your most gullible and vulnerable self,” Paolo ended.

*FOR PRIVACY, NAMES WERE CHANGED AS REQUESTED BY THE INTERVIEWEE

Living life a day at a time – and writing about it, is what Patrick King believes in. A media man, he does not only write (for print) and produce (for a credible show of a local giant network), but – on occasion – goes behind the camera for pride-worthy shots (hey, he helped make Bahaghari Center’s "I dare to care about equality" campaign happen!). He is the senior associate editor of OutrageMag, with his column, "Suspension of Disbelief", covering anything and everything. Whoever said business and pleasure couldn’t mix (that is, partying and working) has yet to meet Patrick King, that’s for sure! Patrick.King.Pascual@outragemag.com

POZ

Holes in the immune system left unrepaired despite HIV drug therapy

A study showed that ART leaves unrepaired holes in the immune system’s wall of defence. This suggests that some of these long-lasting defects may contribute to the lack of viral control once the antiretroviral therapy is interrupted.

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Photo by Drew Hays from Unsplash.com

If they don’t receive antiretroviral therapy (ART), most HIV patients see a progressive weakening of their immune system. But a very small percentage of patients–0.3%–spontaneously control the virus themselves, without ART. Could an explanation lay partly in the sets of genes expressed by scarce white blood cells that recognize HIV? Yes, according to a study published in Nature Immunology and conducted by researchers at the University of Montreal Hospital Research Centre (CRCHUM).

Critical for the coordination of immune responses, CD4 T cells are important white blood cells (lymphocytes) that help control chronic infections like HIV. But on average only about one cell in 1,000 in the CD4 T cell population can recognize the virus.

“With my research team and my collaborators, we comprehensively determined the entire set of genes expressed by these rare cells from the blood of people chronically infected with HIV in whom the virus was abundant prior to ART,” said Daniel Kaufmann, a CRCHUM researcher and an infectious disease specialist. “We then compared it to the cells of HIV controllers, infected people who control the virus in the absence of therapy. This type of powerful approach, also called genome-wide transcriptional profiling, measures the activity of thousands of genes at once, thus creating a global picture of cellular function.”

Using sophisticated cell analysis techniques, lead author Antigoni Morou, a postdoctoral fellow in Kaufmann’s lab, identified major functional differences between the two groups of patients in the study. The HIV controllers had much more robust immune responses, known as Th17 and Th22, which are important for the defense of the gastrointestinal tract, for example. But chronically infected patients with high levels of viral replication showed dysregulated CD4 T cells targeting HIV, and some of their cell subsets showed signs of abnormal functioning.

READ:  Implementing rules and regulations of new HIV Law signed

Continuing their investigation, the CRCHUM scientists wondered whether ART leads to an immune response akin to the one found in HIV controllers. “We followed up chronically infected patients after control of the virus by ART and checked if the treatment can ‘repair their immune system’ and allow them to have CD4 T cells with features similar to those of the HIV controllers,” said Kaufmann, a professor at Université de Montréal.

The result was double-edged: some gene modules were sensitive to ART, while others turned out to be expressed very differently than in HIV controllers.

“We showed that ART leaves unrepaired holes in the immune system’s wall of defence,” said Kaufmann. “Our results suggest that some of these long-lasting defects may contribute to the lack of viral control once the antiretroviral therapy is interrupted. We now know which holes linger in the immune system. Do we have to fill them in, and if so, how? This is another science question.”

Paving the way to new therapies that could complement ART, Kaufmann’s team identified important features of an effective HIV specific immune response compared to a dysfunctional one and showed how the response can be affected by ART.

The next step will be to study the underlying programming of these CD4 T cells (epigenetics) in the hope of developing new targeted strategies to reverse immune dysfunction and complement ART. Kaufmann’s lab is now using the same approach to evaluate candidates for an HIV vaccine.

READ:  At the Lion’s Road

In 2017, nearly 37 million people were living with HIV. Every day, 5,000 new infections are reported to health authorities around the world.

“Altered differentiation is central to HIV-specific CD4+ T cell dysfunction in progressive disease” by Antigoni Morou et al. was published July 15, 2019 in Nature Immunology. The research was funded by the US National Institutes of Health; the Canadian Institutes of Health Research; the AIDS and Infectious Diseases Network of the Fonds de Recherche du Québec-Santé; and a Canada Foundation for Innovation Program Leader grant.

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POZ

For children born with HIV, adhering to medication gets harder with age

Researchers found that from preadolescence to young adulthood, the prevalence of non-adherence increased from 31% to 50%. In addition, the prevalence of detectable viral load among the same age groups increased from 16% to 40%.

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Paolo (not his real name), now nine years old, doesn’t know he has HIV.

Ang alam niya lang, kailangan niya uminom ng gamot gabi-gabi (He just knows he has to drink his meds every night),” his aunt, Virginia, said. “‘Di niya alam para saan ‘yun; basta gamot lang na kailangan niya (He doesn’t even know what they’re for; just that they’re meds that he needs).”

Paolo calls Virginia “mama”, but his biological mother – Virginia’s younger sister Vicky* – already passed away over eight years ago. And when his biological mother died, Vicky’s child Paolo was given to Virginia, the ate (elder sister).

And now that Paolo is growing up, this – the taking of medicines – continues to be an issue that Virginia said is one of those that “we continue to face.”

Apparently, though, this issue is not exactly surprising.

A new study in the US found that children born with HIV were “less likely to adhere to their medications as they aged from preadolescence to adolescence and into young adulthood.” The study – led by researchers at Harvard T.H. Chan School of Public Health – found that additionally, the prevalence of detectable viral load – an indication that the virus is not being managed by medications and a factor that’s often associated with non-adherence – also increased with age.

The study is one of the first to examine why different age groups stop adhering to treatment (non-adherence). While the factors related to non-adherence varied by age group, youth who were concerned about side effects of the drugs were less likely to be adherent at most ages.

READ:  PrEP and PEP for protection in the Phl

“As they approach adulthood, many youth face challenges, such as entering new relationships, managing disclosure of their HIV status, and changing to an adult HIV care provider. Ensuring successful HIV medication adherence before and throughout adolescence is critical,” said lead author Deborah Kacanek, research scientist in Harvard Chan School’s Department of Biostatistics. “We found that the factors that either supported adherence and a suppressed (undetectable) viral load, or made it harder for youth to adhere to treatment, varied depending on their age.”

The study was published in AIDS.

This study is worth highlighting in the Philippines because HIV continues to also affect younger Filipinos.

In April 2019, there were 38 newly diagnosed adolescents 10-19 years old at the time of diagnosis. Further, two cases were 17 years old and 36 cases were 18-19 years old. Almost all (95%) were infected through sexual contact (six male-female sex, 19 male-male sex, and 11 had sex with both males and females), one was infected through sharing of needles and one had no data on mode of transmission. In addition, there were three diagnosed cases less than 10 years old and all were infected through vertical (formerly mother-to-child) transmission.

Globally, 1.8 million adolescents live with HIV; and adhering to regimens of antiretroviral therapy (ART) is key to managing the disease and reducing the risk of transmission. And yet “sticking to a daily regimen of medicine, however, is especially challenging for adolescents and young adults, who are navigating a range of physical, cognitive, social and emotional changes.

READ:  On using phased-out medication

“Adherence can be more complicated for youth growing up with perinatal HIV, whose lifelong experiences with HIV, stigma, and multiple antiretroviral medications may pose challenges to achieving viral suppression that are different from youth who acquire HIV later in life.”

To better understand these challenges and why young people may not adhere to their medications, the researchers followed 381 youth with perinatally acquired HIV for an average of 3.3 years. The youth were participants in the Pediatric HIV/AIDS Cohort Study, which follows children and youth born with HIV or born exposed at birth to HIV to determine the impact of lifelong HIV and the long-term safety of antiretroviral regimens.

The preadolescents, adolescents and young adults in the study ranged from age 8 to 22 and were recruited from 15 different clinical sites in the US, including Puerto Rico. As part of the study, the researchers examined results from blood tests that measured viral loads, and they examined nearly 1,200 adherence evaluations in which study participants or their caregivers self-reported any missed doses of medication in the prior seven days.

The researchers found that from preadolescence to young adulthood, the prevalence of non-adherence increased from 31% to 50%. In addition, the prevalence of detectable viral load among the same age groups increased from 16% to 40%.

For each age group, different factors were associated with nonadherence. For example, during middle adolescence (15-17 years old), alcohol use, having an unmarried caregiver, indirect exposure to violence, stigma, and stressful life events were all associated with nonadherence.

READ:  COSE recognizes Fr. Mickley, contributions to LGBT Filipinos cited

“It is important to talk with youth about how to take medications properly, but our study highlights the need for those who care for these youths to focus also on age-related factors that may influence adherence,” Kacanek said. “Services to help support adherence need to address both the age-related risks and build on the sources of strength and resilience among youth at different stages of development.”

Other Harvard Chan School researchers who contributed to the study include Claire Berman, Yanling Huo, and Katherine Tassiopoulos.

Back in the Philippines, Virginia said that “mabuti ngang may gamot na (si Paolo)… pero marami pa ring isyu na di nasasagot, di nagagawan ng paraan (it’s good Paolo’s already taking antiretroviral medicine… but there are still numerous unanswered/unresolved issues).”

And with dealing with children living with HIV, this still continues to be the case…

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POZ

Antiretroviral agent such as rilpivirine could improve pre-exposure prophylaxis

In an ex vivo model of HIV PrEP using tissue samples in the laboratory, the drug was associated with significant inhibition of HIV replication in rectal tissue, which persisted for up to four months after the last dose of rilpivirine. The drug was not, however, associated with viral suppression in cervicovaginal tissue.

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A long-acting antiretroviral agent such as rilpivirine could further improve pre-exposure prophylaxis (PrEP), already shown to be safe and effective at preventing AIDS in high risk populations, as it could overcome problems with poor medication adherence.

This is according to a new study examining the safety, acceptability, and effectiveness of multiple doses of injected rilpivirine, published in AIDS Research and Human Retroviruses, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers.

The article entitled “A Multiple Dose Phase 1 Assessment of Rilpivirine Long Acting in a Model of Preexposure Prophylaxis Against HIV” was coauthored by Ian McGowan, Orion Biotechnology (Ottawa, Canada) and an international team of researchers from University of Pittsburgh (PA), Magee Women Research Institute (Pittsburgh, PA), Alpha StatConsult (Damascus, MD), University of Liverpool (U.K.), University of Pittsburgh Graduate School of Public Health, Janssen Research and Development (Beerse, Belgium), The Translational Science Corp. (Los Angeles, CA), and University of Miami, Miller School of Medicine (Miami, FL).

In this phase 1 study, women and men received three intramuscular doses of rilpivirine eight weeks apart. The injections were shown to be safe and well tolerated, with injection site pain being the most common adverse effect. In an ex vivo model of HIV PrEP using tissue samples in the laboratory, the drug was associated with significant inhibition of HIV replication in rectal tissue, which persisted for up to four months after the last dose of rilpivirine. The drug was not, however, associated with viral suppression in cervicovaginal tissue.

READ:  At the Lion’s Road

Thomas Hope, PhD, Editor-in-Chief of AIDS Research and Human Retroviruses and Professor of Cell and Molecular Biology at Northwestern University, Feinberg School of Medicine, Chicago, IL states: “There is currently a significant effort to develop long-acting formulations of drugs that prevent HIV replication and can be utilized to prevent HIV acquisition (PrEP). PrEP works if properly taken. Long-acting formulations can eliminate problems when high risk individuals forget to take their pills every day. The development of successful long-acting PrEP formulations will decrease new HIV infections by providing improved protection from HIV acquisition by eliminating problems for individuals who don’t like pills or can’t remember to take their pill every day.”

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POZ

PLHIV who have compassionate care providers start, remain in treatment longer

Rutgers researchers find patients who perceive their primary care providers as lacking empathy and not willing to include them in decision making are at risk for abandoning treatment or not seeking treatment at all.

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Photo used for illustration purpose only. Photo by Vittore Buzzi from Unsplash.com.

Adults with HIV are more likely to continue life-saving treatments if their primary health care providers show respect, unconditional empathy without judgement and demonstrate an ability to partner with patients in decision making to address their goals, a Rutgers study finds.

The systematic review appears in the Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports.

The findings showed that the complexity of the illness, treatment regimen and overall healthcare system frequently overwhelms the patient and fear of stigma often prevents them from beginning or continuing treatment. The researchers found that patients need help in understanding their illness and care needs using understandable language to translate complex information, letting patients know what to expect and reinforcing that HIV is now a treatable, yet complex, chronic illness.

“Today, HIV is considered a chronic, treatable condition. However, this study found that many patients continue to view it as a death sentence,” said lead author Andrea Norberg, executive director of the François-Xavier Bagnoud Center at Rutgers School of Nursing, which provides care for people with HIV, infectious diseases and immunologic disorders. “We know that people who are knowledgeable about HIV, who are engaged in care and taking antiretroviral therapy medications remain relatively healthy. Our challenge is to reach those people diagnosed with HIV and who are not retained or engaged in ongoing care. In the United States, this is approximately 49 percent of the 1.1 million people diagnosed.”

The researchers included 41 studies published between 1997 to 2017. The sample populations included adults with HIV and their healthcare providers. All adults with HIV were between the ages of 18 and 65, represented diverse races and ethnicities, sexual orientations and gender identities. Healthcare providers included physicians, nurse practitioners, physician assistants, pharmacists, social workers and others. The included studies had 1,597 participants.

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They found that many patients experience stigma and a lack of compassion that is often grounded in primary care providers’ ignorance about HIV and transmission risks. The resulting poor communication between providers and patients results in many patients’ failure to seek or remain in care and adhere to antiretroviral therapy medications.

Patients reported feeling “grilled” by providers who often assumed they were not taking medications. Norberg suggested providers would be more successful in getting information from patients by allowing them to be honest, inquiring about their health goals and telling them how other patients have managed treatment.

Conversely, the researchers found that patients were more inclined to adhere to HIV treatment when their primary care providers showed empathy, true listening, trust, consideration of the whole person and involvement in decision making. However, many patients reported that healthcare providers viewed care only as “prescribing antiretroviral therapy medicine.”

“Providers should use common language, not medical jargon, to educate patients about HIV, medications and how they can live a healthy life,” Norberg said. “They should thoroughly teach them about the disease, the medications and side effects, and the meaning of the tests.”

The researchers noted that providers who help patients navigate the health system, offer one-stop location of services and provide connections to psychological support, health insurance, medicine, transportation and other services, can help their patients stay engaged in care.

Primary healthcare providers can enroll in professional education to improve their knowledge about HIV, use of motivational interviewing skills and seek opportunities for experiential learning, observation and hands-on practice working directly with patients with HIV, Norberg said.

READ:  At the Lion’s Road

Other Rutgers authors included John Nelson, Cheryl Holly, Sarah T. Jewell and Susan Salmond.

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Persistent HIV DNA in spinal fluid may be associated with cognitive challenges

Individuals who harbored HIV DNA in the cerebrospinal fluid were more likely than other study participants to experience cognitive deficits on neurocognitive testing.

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Photo by Emiliano Vittoriosi from Unsplash.com

A study found that HIV DNA remained in the cerebrospinal fluid of half of participants with well-managed HIV (virologic suppression in the plasma), confirming that the central nervous system (CNS) is a major reservoir for latent HIV. Individuals who harbored HIV DNA in the cerebrospinal fluid were more likely than other study participants to experience cognitive deficits on neurocognitive testing.

This was disclosed by investigators from the AIDS Clinical Trials Group (ACTG), the world’s largest and longest-established HIV research network, as announced in the Journal of Clinical Investigation from the ACTG HIV Reservoirs Cohort Study (A5321).

“The persistence of HIV in sanctuary sites in the human body, even in the presence of long-term therapy, is a challenge to HIV remission and cure that the ACTG is actively working to address,” said ACTG Chair Judith Currier, M.D., MSc, University of California Los Angeles. “Because neurocognitive function can be compromised even in individuals whose HIV is well treated, it is very important that we understand HIV persistence in the CNS so that we can develop strategies to treat it. This study provides preliminary insights into these challenges.”

This substudy in the ACTG HIV Reservoirs Cohort Study (A5321) was led by Serena Spudich, M.D., Yale University, the late Kevin Robertson, Ph.D., University of North Carolina at Chapel Hill, and John Mellors, M.D., University of Pittsburgh.

The study included 69 participants with well-treated HIV who had their cerebrospinal fluid and blood collected and underwent neurocognitive assessments, which included tests of memory, learning, motor function, and more.

READ:  New studies, WHO guidance clarify way forward for use of dolutegravir in women of childbearing age

Participants were mostly male (97 percent) and had been on HIV treatment for a median of almost nine years, with a good response to medications (HIV viral loads in the plasma were all <100 copies/mL and median CD4 counts were in the normal range).

Using highly sensitive methods to detect HIV, researchers found that almost half of these participants harbored viral DNA in cells found in the cerebrospinal fluid. Of those, 30 percent met the criteria for cognitive impairment.

While the study established an association between HIV DNA in cerebrospinal fluid with poorer performance on cognitive tests, researchers stressed that it did not establish a causal relationship, noting that there could be several explanations for the findings. Further studies will help determine strategies to reverse this persistence and improve neurological functioning in individuals with long-standing HIV.

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New studies, WHO guidance clarify way forward for use of dolutegravir in women of childbearing age

Additional research from Botswana has found that the risk of NTDs is less than was signalled last year. To help clinicians and health ministries act on these findings, WHO issued updated recommendations on antiretroviral therapy and DTG use.

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The safety of the HIV treatment drug, dolutegravir (DTG), during pregnancy has been one of the most urgent questions in global health for the past year.

At the 22nd International AIDS Conference (AIDS 2018) last year, data from the Tsepamo study in Botswana suggested that the use of DTG in early pregnancy may be linked to neural tube defects (NTDs), serious birth defects of the brain and spine.

As a result, some countries have paused their plans to make DTG-based regimens their preferred first-line therapy and the World Health Organization (WHO) issued a note of caution about the use of DTG by women of childbearing age as part of its interim guidelines recommending DTG as the preferred first- and second-line antiretroviral therapy for people living with HIV.

At the 10th IAS Conference on HIV Science (IAS 2019), additional research from Botswana has found that the risk of NTDs is less than was signalled last year. To help clinicians and health ministries act on these findings, WHO issued updated recommendations on antiretroviral therapy and DTG use.

To inform these recommendations, a number of community and scientific forums were held to discuss the issue directly with women of reproductive age who have the least access to obtaining DTG. 

“Community engagement, including input from women living with HIV, has played a key role in updating these recommendations and will be critical to rolling them out,” Jacque Wambui, African Community Advisory Board (AFROCAB) member, Kenya, said.

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“Ultimately, what is most important is offering women the choice to make informed decisions,” Anton Pozniak, International AIDS Society President and IAS 2019 International Scientific Chair, said.

WHO updated these recommendations based on new evidence.

Botswana’s Tsepamo study analysed more than 119,000 deliveries from August 2014 to April 2019, including nearly 1,700 among women who were taking DTG-based therapy around conception. With more data, the researchers have found the risk in the prevalence of NTDs among women taking DTG is less than originally signalled. Specifically, NTDs occurred in three per 1,000 deliveries among women on DTG from conception – compared with one per 1,000 deliveries among women taking other ARV regimens.

A second analysis from Botswana analysed health facilities that were not included in the Tsepamo study. Examining data from 22 facilities from October 2018 to March 2019, researchers confirmed one case of NTDs in pregnancies of 152 mothers who had been taking DTG-based therapy at conception. By comparison, two cases of NTDs occurred among pregnancies of more than 2,300 HIV-negative mothers.

Meanwhile, a surveillance-based analysis from Brazil included 1,468 women who became pregnant while taking antiretroviral therapy – 382 of whom were taking DTG at conception. In this case, no cases of NTDs were seen. This evidence backs up the overall conclusion that even if DTG-based therapy is associated with an elevated risk of NTDs, the risk remains quite low.

To help put these findings in context and to provide urgently needed guidance, WHO issued updated recommendations on antiretroviral treatment. These guidelines reconfirm the recommendation to use DTG-containing regimens as the preferred option for first-line and second-line antiretroviral treatment (ART) across all populations.

READ:  At the Lion’s Road

The guidelines development group also emphasized the need for ongoing monitoring of the risk of NTDs and the importance of supporting women’s autonomy in decision making and informed choice. 

“There is still a risk that we and countries need to monitor closely, but at this point, dolutegravir should be accessible for women of childbearing age due to the overwhelming benefits it offers,” Meg Doherty, Coordinator of Treatment and Care in the Department of HIV/Hepatitis and STIs at WHO, said. “What treatment options to pursue is a decision that a woman should make in consultation with her healthcare provider.”

Ambassador Deborah L. Birx, U.S. Global AIDS Coordinator and U.S Special Representative for Global Health Diplomacy, commented that the President’s Emergency Plan for AIDS Relief (PEPFAR) was committed to supporting countries in their continued transition to DTG. “DTG offers many benefits, including that it is better tolerated by the patient, leads to improved outcomes, such as faster viral suppression, and often costs less,” she said. “It is clear that transitioning to DTG will accelerate our progress toward controlling the HIV epidemic.”

Earlier this month, Pozniak, Doherty and Wambui alongside several other coauthors, released a commentary entitled “Optimizing responses to drug safety signals in pregnancy: the example of dolutegravir and neural tube defects.” Published in the Journal of the International AIDS Society (JIAS), the piece provided additional context before the new data shared at IAS 2019 became available.

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