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New researches provide understanding of real-world use of PrEP

One study provided new national estimates of PrEP use in the US by geography and other demographics, another found the near elimination of HIV transmission risk among serodiscordant heterosexual couples using both PrEP and antiretroviral treatment, and two additional studies examined PrEP use among adolescents in both southern Africa and the U.S.

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New studies presented at the 2016 International AIDS Conference in Durban provide new insights on the use of PrEP among a broad range of populations. One study provided new national estimates of PrEP use in the US by geography and other demographics, another found the near elimination of HIV transmission risk among serodiscordant heterosexual couples using both PrEP and antiretroviral treatment, and two additional studies examined PrEP use among adolescents in both southern Africa and the US.

Research featured in the briefing included:

Increased PrEP use among US adults: A nationally representative study assessing PrEP use in the U.S. found that 49,469 adults received a Truvada prescription for PrEP from January 2013 to December 2015, and that the number of prescriptions increased nationally over time: 3,746 in 2013; 14,756 in 2014; and 30,967 in 2015.

Scott McCallister of Gilead Sciences, the manufacturer of Truvada, presented the study, which included de-identified data from 82% of retail pharmacies on adults who received a Truvada prescription.

Study results also showed that the four states with the highest number of new HIV cases in the US (California, New York, Texas, and Florida) accounted for 43% of PrEP starts. From 2014 to 2015, PrEP starts increased in the South and Northeast, and decreased in the Midwest and West. The vast majority of PrEP prescriptions were for males (87.5%), and the mean age was 37.4 years, with 11.5% under age 25. Compared to HIV-positive individuals, those receiving PrEP were about three times less likely to be female (95% CI 3.0-3.2) and twice as likely to be under age 25 (95% CI 1.93-2.05).

Despite positive trends in utilization, authors conclude that PrEP use must increase to ensure that lifetime HIV risk decreases in areas of high prevalence in the US.

Combination of PrEP and ART leads to near elimination of HIV transmission among serodiscordant couples: Final results from the Partners Demonstration Project, an open-label PrEP and ART delivery study that enrolled treatment-naïve, high-risk, heterosexual HIV serodiscordant couples from Kenya and Uganda, found that integrated use of PrEP and ART nearly eliminated HIV transmission within these couples. Of 1,013 couples enrolled, 67% had an HIV-positive female partner; median age was 29.

Among a randomly selected sample of HIV-negative partners receiving PrEP, tenofovir was detected in 82% of plasma samples (483/587 visits). Treatment was initiated by 92% of HIV-positive partners by 24 months, and viral suppression (<400 copies/mL) was achieved in 90%. As of January 2016, scientific models predicted that 63 incident HIV infections would be expected (incidence rate 5.1 per 100 person years, 95% CI 3.9-6.4).

However, Jared Baeten of the University of Washington reported that only five incident infections had actually been observed (incidence rate 0.3, 95% CI 0.1-0.7), for a sustained HIV relative risk reduction of 94% (95% CI 85-98, p<0.001). The results show near elimination of HIV risk among a high-risk cohort. 

Closer look at PrEP use among adolescents at risk: Plus Pills is the first southern African open-label study to explore the acceptability, safety, and use of oral PrEP among HIV-negative adolescents (ages 15-19 years). Study participants (n=148; 98 female and 50 male) enrolled in two sites, Cape Town and Soweto. Median age of study participants was 18 and median age at sexual debut was 15. Participants were required to take PrEP daily for the first 12 weeks of the study, but could opt out at the 12-week mark and at each 3-month interval thereafter.

At enrolment, participants reported an average of 1.5 weekly sex acts, 30% had two or more partners in the past 12 months, 43% reported infrequent condom use, and 38% tested positive for sexually transmitted infections. Lead author Katherine Gill of the Desmond Tutu HIV Centre discussed the study results, which found no HIV incident infections. At 12 weeks, 72% reported good adherence (>6 pills/week) and 76% had tenofovir plasma levels (>40 ng/ml).

At the 12-week mark, 15% of participants chose to opt out. According to study authors, results showed that early adherence was reasonable among a high-risk adolescent population

A separate open-label study looked at PrEP use among gay and bisexual male adolescents (ages 15-17) in six U.S. cities. While Truvada is not currently licensed for PrEP among individuals under age 18, participants were permitted to autonomously consent to the study.  Between August 2013 and September 2014, ATN 113 (Project PrEPare) enrolled 78 individuals (mean age=16.5; 33.3% mixed race, 29.5% black, 20.5% Latino). Sybil Hosek of the Stroger Hospital of Cook County Health and Hospitals System presented the study results. Incident sexually transmitted infections were diagnosed in 12.3% of participants at week 24 and 10.6% at week 48. The HIV seroconversion rate per 100 person-years was 6.41 (95% CI: 4.90-25.87). The majority of participants reported condomless sex throughout the study; no significant associations were found between condomless sex and adherence. While the majority of participants achieved protective drug levels during monthly visits, the study found that adherence decreased with quarterly visits.

Op-Ed

I may be HIV+ but that still doesn’t mean I’ll sleep with you

This is something every PLHIV needs to learn. That we are still “worth it”. Forget these notions of you being a “damaged good” or a “dirty person” or banalities given us along those lines. Because my HIV status is just one facet of my outrageous (and fabulous) personality; it does not define me.

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“I’m HIV-positive.”

That was the short sentence I remember telling this guy I used to date.

Okay – to backtrack – I met a guy while I was in Northern Mindanao. We dated for a while, and – at least I thought – things between us went smoothly for a while. I’d say he wasn’t bad-looking even if he looked somewhat common. He had one of those “if you stay long enough, I can teach myself to maybe even like you” face.

And then one night, we became more intimate than the usual. So I had to stop what we were doing (before we progressed further). And then – after prepping him up by first discussing with him his views about HIV and people living with HIV – I told him I had something important to tell him (if we were to advance what we had).

Thus that short sentence.

His face immediately changed; from what I saw was longing to… shocked. He couldn’t even say a word. And when he was finally able to utter a word, it was just to tell me that “I forgot I had to be elsewhere.”

The alibi was lame. But what made it more insulting was that I wasn’t even that into him to begin with; he was just a possible lay (if it came to that).

But that moment taught me two important things.

On one hand, how the sexuality of so many PLHIVs are tempered by their status.

I have frequently heard of medical practitioners who tell PLHIVs to “already stop having sex now that you’re HIV-positive; dadami pa kayo (you’d abet in increasing the number of PLHIVs)” – all too obviously unaware of safer sexual practices and U=U, among others. Worse, this sentiment is shared by a lot of PLHIVs themselves, who see their status as a “punishment”, and the only “cure” is to stop having sex altogether. Oh, please!

On the other hand, recognizing that being sexual doesn’t disappear (and doesn’t need to vanish) with being HIV-positive, there seems to be this supposition of PLHIVs being “desperate”.

That guy I dated, for instance, had every right NOT to have sex with me (it’s called power over one’s body); but that he had to lie just to get away from me was – to admit the truth – not only discourteous but even insulting. I suppose particularly because… I wasn’t even that into him.

Here’s the thing: Me living with HIV means just that – that I have HIV. But it doesn’t mean that I’ve lost my (yes!) sexual appetite and (for that matter) taste/preferences/standards on who to do it with.

And I believe this is something every PLHIV needs to learn. That we are still “worth it”. Forget these notions of you being a “damaged good” or a “dirty person” or banalities given us along those lines. Because my HIV status is just one facet of my outrageous (and fabulous) personality; it does not define me. And if (some) guys can’t see that, well…

Because remember dearie, just because I am HIV-positive still doesn’t mean I’ll sleep with you.

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POZ

CDC in the US releases recommendations for Covid-19 vaccine for PLHIVs

According to the CDC, “adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes Covid-19.” It added that “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.”

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With the Department of Health (DOH) still not releasing guidelines re vaccinations in the Philippines including of Filipinos living with HIV, eyes are turning – instead – to international bodies that already released recommendations for the same. One such body, the Center for Disease Control and Prevention (CDC) – released in end-2020 its “Vaccination Considerations for Persons with Underlying Medical Conditions”.

According to the CDC, “adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes Covid-19.” It added that “mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine.”

The CDC noted that PLHIVs were actually included in clinical trials, but “safety data specific to this group are not yet available at this time.” It saw fit to stress this point: “Information about the safety of mRNA COVID-19 vaccines for people who have weakened immune systems in this group is not yet available.”

Nonetheless – and this is worth stressing – because “PLHIVs and those with weakened immune systems due to other illnesses or medication might be at increased risk for severe Covid-19… they may receive a Covid-19 vaccine.”

Aside from v=being aware of the potential for reduced immune responses to the vaccine, those with weakened immune systems (including PLHIVs) should continue following all current guidance to protect themselves against Covid-19.

  • Wearing a mask
  • Staying at least six feet away from others
  • Avoiding crowds
  • Washing hands with soap and water for 20 seconds or using hand sanitizer with at least 60% alcohol
  • Following (CDC) travel guidance
  • Following quarantine guidance after exposure to Covid-19
  • Following any applicable workplace guidance
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POZ

Risk of developing cervical cancer is six times higher in women with HIV

Cervical carcinomas are usually caused by infections with Human papillomavirus (HPV), which are sexually transmitted just as HIV is. Based on the results of a new study, it can be assumed that an infection with HIV represents a risk factor for an infection with HPV.

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The risk of developing cervical cancer is six times higher in women who are infected with HIV.

This is according to a study from the TUM School of Medicine’s Center for Global Health and the chair of Epidemiology at the TUM Department of Sport and Health Sciences – “Estimates of the Global Burden of Cervical Cancer Associated with HIV” – that was published in the The Lancet Global Health.

According to WHO statistics, cervical cancer is the fourth most common type of cancer for women. In 2018 an estimated 570,000 women worldwide were diagnosed with cervical carcinoma, with approximately 311,000 of these women dying.

On the other hand cervical cancer, usually caused by Human Papillomavirus (HPV), is also one of the most successfully preventable and treatable types of cancer, as long as it is detected at an early stage and treated effectively.

Cervical cancer is at the same time the most frequently detected cancer for women who live with HIV, since their immune systems are weakened by the HIV infection.

Systematic review and meta-analysis of 24 studies

The lead authors Dr. Dominik Stelzle (Center for Global Health and Chair of Epidemiology) and Dr. Luana Tanaka (Chair of Epidemiology) conducted a systematic review as well as a meta-analysis of a total of 24 studies from the years 1981 to 2016, in which 236,127 women with HIV from four continents (Africa, North America, Asia and Europe) participated.

These studies covered a total of 2,138 cervical carcinoma cases. The results were linked with data from UNAIDS on worldwide HIV infection and with data on cervical carcinoma from the International Agency for Research on Cancer (IARC), the WHO’s Cancer Research Center, and then evaluated.

“Until now there have only been estimates from countries with high net income levels,” says Dr. Stelzle. “That’s why we looked at the figures on global incidence of cervical carcinoma in connection with an HIV infection and included estimates for countries with low net incomes. In most parts of the world the numbers are under five percent. In some countries however we’re talking about well over 40 percent of cases.”

Risk is six times higher for women with HIV

The objective of the study was to calculate the share of women living with HIV among the number of women with cervical cancer. The authors found that 5.8 percent of all new cervical cancer cases worldwide in the year 2018 were diagnosed for women with an HIV infection. This is equivalent to 33,000 cases a year, 85 percent of which occurred in Sub-Saharan Africa.

Furthermore, based on their results the team was able to show that women with HIV have a sixfold higher risk of developing cervical cancer than women without HIV infection.

“The association between cervical carcinoma and HIV is plausible,” says Prof. Andrea S. Winkler, co-director of the Center for Global Health. “Cervical carcinomas are usually caused by infections with Human papillomavirus (HPV), which are sexually transmitted just as HIV is. Based on our results it can be assumed that an infection with HIV represents a risk factor for an infection with HPV.”

Based on the results, the TUM authors determined that women with an HIV infection have a significantly higher risk of developing cervical cancer. They also pointed out that this means that HPV vaccinations and early-stage cervical carcinoma screenings are of particular importance.

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POZ

How the vaginal microbiome may affect HIV prevention

With no effective vaccine for HIV, alternative strategies such as pre-exposure prophylactic (PrEP) drugs are necessary to prevent transmission. PrEP drugs are highly effective in preventing the acquisition of HIV infection in men, but they are much less effective at preventing HIV infection in women.

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Healthy Lactobacillus bacteria in the vagina are critical for women’s health, but the accumulation of additional bacterial genera can imbalance the vaginal ecosystem. Such an imbalance may result in bacterial metabolism of drugs designed to prevent HIV infection, thereby decreasing their effectiveness and enhancing risks to women.

This is according to a study published in the open-access journal PLOS Pathogens by Dr. Nichole Klatt of the University of Minnesota Medical School, and colleagues.

With no effective vaccine for HIV, alternative strategies such as pre-exposure prophylactic (PrEP) drugs are necessary to prevent transmission. PrEP drugs are highly effective in preventing the acquisition of HIV infection in men, but they are much less effective at preventing HIV infection in women.

Recent evidence demonstrates that vaginal microbial communities are associated with increased HIV acquisition risk and may impact PrEP efficacy. To better design and conduct clinical studies assessing HIV prevention in women, it is essential to understand how microbes in the female reproductive tract affect therapeutic drug levels.

In the new study, Klatt and her colleagues investigated how vaginal bacteria alter PrEP drug levels and impact HIV infection rates using cervicovaginal lavage samples from women with and without bacterial vaginosis (BV) – a highly common syndrome in women that is caused by bacteria that can induce itching, discharge and discomfort, and has been associated with increased sexually transmitted infections and negative reproductive tract outcomes in women.

However, current treatments for BV frequently fail and recurrence is common. The researchers found that bacteria associated with BV – but not healthy Lactobacillus bacteria – can metabolize PrEP drugs and may potentially reduce PrEP efficacy due to reduced levels of available preventative drug. According to the authors, better measurements and interventions for bacterial vaginosis will be critical for improving the efficacy of HIV prevention efforts in women.

Dr. Klatt highlights, “women’s health, and factors that contribute to health and disease prevention in women are grossly under studied. This study demonstrates the critical need to develop better treatments for bacterial vaginosis, and in general, to promote more studies of women’s health.”

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POZ

Dep’t of Health dispenses newer HIV drug in the Phl

The Department of Health (DOH) is introducing LTD (lamivudine, tenofovir, dolutegravir) in the country.

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Took them long enough…

Xander (not his real name) has been HIV-positive since December 2012; and from the very first time he took his antiretroviral (ARV) medicines, “it has always been LTE (for lamivudine, tenofovir, efavirenz),” he said.

There have been adverse side effects – e.g. “At night, my dreams are so vivid I am unable to distinguish what’s real or what’s not,” Xander said, adding with sadness that “the doctor just told me to ‘Drink more water!’ as if that’d solve my problem.”

Those like Xander may now have their ARVs changed, with the Department of Health (DOH) introducing LTD (for lamivudine, tenofovir, dolutegravir) in the country.

This December, the Global Fund for treatment of people living with HIV (PLHIV) donated 197,260 bottles of LTD. The stock is being managed by the DOH’s Disease Prevention and Control Bureau – National HIV, AIDS and STI Prevention and Control Program.

The first tranche of 98,630 bottles were already allocated to various Centers for Health Development, while the last tranche (98,630 bottles) are expected to arrive in the country before the end of the year.

In an advisory signed by Undersecretary of Health Dr. Myrna Cabotaje, the DOH stated that based on the National Plan for LTD Introduction, the new ARV will be introduced from now until December 2021. These sub-populations of PLHIVs can benefit from LTD:

  • ART-naive adults, adolescents and children (30 kg and above), excluding TB patients on rifampicin-based regimen
  • PLHIVs on LTE with severe adverse events (dizziness, insomnia, abnormal dreams, anxiety, depression, mental confusion, convulsions, hepatoxicity, severe skin and hypersensitivity reactions and gynecomastia)
  • Patients with treatment failure to zidovudine (AZT) and abacavir (ABC)-based regimens

Xander knows he has to broach his concerns to the doctor in his treatment hub again to ascertain if he can shift from LTE to LTD. And “the DOH really took its time,” he mused, adding that hopefully, “this is just one of the steps wherein Filipino PLHIVs actually already start being able to access life-saving HIV meds already widely available in more developed countries.”

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Even with limited HIV services due to Covid-19, Phl reports 21 new HIV cases per day

Even with Covid-19 affecting the delivery of HIV-related services, the country is still reporting 21 new HIV cases per day. In October 2020, there were 735 new HIV-positive individuals reported to HARP.

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AIDS: The other pandemic.

Even with Covid-19 affecting the delivery of HIV-related services – that were already problematic even pre-pandemic – the country is still reporting 21 new HIV cases per day. This is according to the latest (for October 2020) report from the HIV/AIDS & ART Registry of the Philippines (HARP) of the Department of Health’s (DOH) Epidemiology Bureau.

Specific to October 2020, there were 735 new HIV-positive individuals reported to HARP; and 21% (153) of them had clinical manifestations of advanced HIV infection at the time of testing.

MEN IN MOST CASES

A big chunk of the newly infected are still male; and not just members of the LGBTQIA community, it must be emphasized.

Ninety-six percent (704) of the reported new cases were male. The median age was 28 years old (age range: 3-60 years old). More than half of the cases (52%, 379) were 25-34 years old and 28% (204) were 15-24 years old at the time of diagnosis.

More than a third (40%, 295) were from the National Capital Region (NCR). Region 4A (20%, 146), Region 3 (16%, 121), Region 6 (7%, 54), and Region 12 (5%, 36) comprised the top five regions with the most number of newly reported cases for this reporting period, together accounting for 88% of the total cases.

Sexual contact remained as the predominant mode of transmission or MOT (99%, 725). Among the newly reported cases infected through sexual contact, 60% (437) reported transmission through male-to-male sex, 28% (200) through males who have sex with both males and females, and 12% (88) were through male-to-female sex.

There were nine cases (1%) that had no data on mode of transmission.

YOUTH AND HIV

Even if there are less HIV services, trends noted in the past continue – e.g. youth continue to be greatly affected by HIV.

In October 2020, 204 (28%) cases were among youth 15-24 years old; and 94% of them were male. Almost all (99%, 201) were infected through sexual contact (20 male-female sex, 136 male-male sex, 45 sex with both males & females), and 1% (3) had no data on the MOT.

Children (<10) and adolescents (10-19) were also infected.

There were 27 newly diagnosed adolescents. Of these, six were 15-17 years old and 21 were 18-19 years old. All newly reported adolescent cases were infected through sexual contact (five male-female sex, 20 male-male sex, two sex with both males and females ).

Further, one child was diagnosed with HIV in this reporting period was infected through vertical transmission (formerly: mother-to-child transmission).

HIV AMONG OFWs

Fifty-four Filipinos who worked overseas within the past five years, whether on land or at sea, were newly diagnosed in October 2020. They comprised 7% of the total cases for this period. Of these, 93% (50) were male.

All of the male cases were infected through sexual contact (eight male-female sex, 27 male-male sex, and 15 sex with both males and females).

The ages of male OFWs ranged from 23 to 54 years (median: 33 years). More than half (54%, 27) of the male cases were 25-34 years old at the time of testing and 36% (18) were 35-49 years old. Among the four female OFWs, all where infected through male-female sex.

Seventy-five percent (3) were 25-34 years older at the time of testing and 25% (1) were 35-49 years old. The age range among diagnosed female OFWs were from 27 to 35 years (median: 32 years old).

PREGNANT WOMEN LIVING WITH HIV

Still in October, 13 were reported pregnant at the time of diagnosis. Five cases each were from NCR and Region 4A; and one case each from Regions 3, 10 and 12.

Reporting of pregnancy status at the time of diagnosis was included in the HARP only starting year 2011. From January to October 2020, there were 85 HIV positive women reported pregnant at the time of diagnosis. Of these, 35% (30) were from NCR, 22% (19) were from Region 4A, 16% (14) were from Region 3 and 27% (22) were from the rest of the country. The age of diagnosis ranged from 15 to 45 years old (median age: 25).

TRANSACTIONAL SEX

In October 2020, 13% (93) of the newly diagnosed engaged in transactional sex. Ninety-nine percent (92) were male and aged from 19 to 57 years old (median: 30 years). Fifty-two percent (48) of the males reported paying for sex only, 29% (27) reported accepting payment for sex only and 18% (17) engaged in both. Further, there was one female aged 23 years old who had engaged in transactional sex and was reported to have accepted payment for sex only.

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 starting December 2012.

TREATMENT FOR PLHIVs

In October 2020, there were 579 patients who were initiated on ART. The median CD4 of these patients upon enrollment was 153 cells/mm3.

To date, a total of 47,013 PLHIVs are on ART. This is only a little more than half of the total 81,169 HIV cases in the country as of end-October.

Most (96%) of those using ART are males. The age of reported cases ranged from 1 to 79 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.

DEATHS AMONG PEOPLE WITH HIV

Perhaps the number of deaths among PLHIVs highlight the under-reporting in the country as far as HIV is concerned. Since data was gathered in January 1984, only 4,444 deaths were reported, and the real figure may be much higher though affected by both under- and non-reporting.

In October 2020, specifically, there were 248 reported deaths due to any cause among PLHIVs. Ninety-six percent (238) were males. One case (<1%) was less than 15 years olds at the time of death, 29 (12%) cases were 15-24 years olds, 109 (44%) were 25-34 years olds, 79 (32%) were 35-49 years olds, and 27 (11%) were 50 years and older.

Ninety-five percent (235) of the cases were reported to have acquired the infection through sexual contact (37 through male-female sex, 124 through male-male sex, 74 through sex with both males and females), 3% (7) through sharing of infected needles, and <1% (1) were infected through mother and child. Five (2%) reported deaths had no data on MOT.

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