[Viva] Fwd: CROI 2021: Long-acting injectables for HIV treatment and prevention, Wednesday 17 March 2021

Sat Mar 20 17:00:02 PDT 2021

thanks Margarite!

On Sat, Mar 20, 2021 at 4:50 PM Margarite Sanchez <
margaritesanchez at gmail.com> wrote:

> Some updates from the CROI conference.
> M
>
> ---------- Forwarded message ---------
> From: <bulletins at bulletins.aidsmap.com>
> Date: Wed, Mar 17, 2021 at 7:43 AM
> Subject: CROI 2021: Long-acting injectables for HIV treatment and
> prevention, Wednesday 17 March 2021
> To: <margaritesanchez at gmail.com>
>
>
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>
> 17 March 2021   |   News from CROI 2021
>
> Contents
>
>    - Long-acting injectables for HIV treatment and prevention
>    <#m_-7077619351413114226_m_8820032774637737376_section-1?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    - African HIV programmes ‘resilient’ during COVID-19 pandemic
>    <#m_-7077619351413114226_m_8820032774637737376_section-2?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    - São Paulo patient has detectable viral load again
>    <#m_-7077619351413114226_m_8820032774637737376_section-3?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    - Gender-affirming surgery associated with sustained viral suppression
>    <#m_-7077619351413114226_m_8820032774637737376_section-4?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    - What are the roles of TAF and integrase inhibitors in weight gain?
>    <#m_-7077619351413114226_m_8820032774637737376_section-5?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    - Four-days-on, three-days-off treatment regimen still looks effective
>    after two years
>    <#m_-7077619351413114226_m_8820032774637737376_section-6?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>
>
> Long-acting injectables for HIV treatment and prevention
> [image: Carlos del Rio, Diane Havlir, Charles Flexner, Francois Venter,
> Hyman Scott, Nittaya Phanuphak (top to bottom, left to right) at CROI 2021.]
> Carlos del Rio, Diane Havlir, Charles Flexner, Francois Venter, Hyman
> Scott, Nittaya Phanuphak (top to bottom, left to right) at CROI 2021.
>
> A panel discussion at the virtual Conference on Retroviruses and
> Opportunistic Infections (CROI 2021)
> <https://www.aidsmap.com/conference/croi-2021?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
> highlighted the importance of injectable HIV medications being practical
> and affordable.
> <https://www.aidsmap.com/news/mar-2021/injectable-hiv-medications-must-be-practical-and-affordable-conference-hears?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>
> Professor Diane Havlir said that HIV treatment advances in the last decade
> were dominated by potent integrase inhibitors and single-tablet regimens,
> but the next decade promises to be an era of long-acting products.
>
> Professor Francois Venter said that in South Africa there is great
> enthusiasm from patients for long-acting agents, while healthcare providers
> have more concerns about operational challenges. South Africa’s successful
> antiretroviral therapy programme is the largest in the world and adapting
> to injectable treatment would mean a rethink of workflow in overstretched
> clinics. Venter was more open to the potential benefits of injectable
> pre-exposure prophylaxis (PrEP), given the limited numbers who have been
> reached by oral PrEP so far.
>
> The first long-active formulation of PrEP, injectable cabotegravir, may be
> on the market by the end of this year or early next year. It’s not yet
> known how much it will cost.
>
> An analysis presented to CROI 2021
> <https://www.aidsmap.com/news/mar-2021/be-cost-effective-injectable-prep-can-only-cost-about-3000-more-us-generic-oral-prep?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>,
> by Dr Anne Neilan of Massachusetts General Hospital, found that in order to
> be cost-effective in the US, it would have to cost less than half the list
> (maximum) price for the injectable cabotegravir/rilpivirine combination
> *Cabenuva*, which is licensed for HIV treatment.
>
> In order to be more cost-effective than generic tenofovir disoproxil
> fumarate/emtricitabine (TDF/FTC) (which costs $8300 a year in the US),
> injectable cabotegravir (CAB-LA) would have to cost no more than $11,600.
> At this price, it would cost just below $100,000 per extra quality-adjusted
> life year saved, which is the maximum threshold for what’s usually regarded
> as cost-effective in the US.
>
> In Europe and elsewhere, generic TDF/FTC can be bought for around $300-900
> a year. Although not analysed by Neilan’s team, the model implies that
> because of the superior effectiveness of long-acting cabotegravir in
> preventing HIV infections, it could still be cost-effective or cost-saving
> in the long run in a European scenario, but only at a price of
> approximately $2000-3000 a year.
>
> A separate study reported at CROI found that cabotegravir (*Vocabria*)
> and rilpivirine (*Rekambys*) injections given every four or eight weeks
> for HIV treatment maintained viral suppression throughout the two-year
> follow-up period of the study
> <https://www.aidsmap.com/news/mar-2021/every-other-month-injectable-cabotegravir-and-rilpivirine-suppresses-viral-load-two?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
> .
>
> The European Medicines Agency approved the injectable combination in
> December 2020, supporting both a once-monthly and an every-other-month
> regimen. However, regulators in the US and Canada (where the injections are
> marketed together as *Cabenuva*) only approved the monthly regimen.
>
> The ATLAS-2M study worked with 1045 participants who were randomly
> assigned to either receive injections of 400mg cabotegravir and 600mg
> rilpivirine every four weeks or 600mg cabotegravir and 900mg rilpivirine
> every eight weeks. After two years, 90.2% of participants in the
> once-monthly group and 91.0% in the every-other-month group maintained
> viral suppression.
>
>    - *Read about the panel discussion in full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/injectable-hiv-medications-must-be-practical-and-affordable-conference-hears?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>*
>    - *Read about the cost-effectiveness analysis of injectable PrEP in
>    full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/be-cost-effective-injectable-prep-can-only-cost-about-3000-more-us-generic-oral-prep?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>*
>    - *Read about the ATLAS-2M study in full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/every-other-month-injectable-cabotegravir-and-rilpivirine-suppresses-viral-load-two?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    *
>    - *Visit our conference news pages for all our CROI 2021 coverage
>    <https://www.aidsmap.com/conference/croi-2021?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>*
>
>
> African HIV programmes ‘resilient’ during COVID-19 pandemic
> [image: Dr Tiffany Harris presenting at CROI 2021.]
> Dr Tiffany Harris presenting to CROI 2021.
>
> Data from over 1000 health facilities in eleven countries in sub-Saharan
> Africa showed a transient effect of the COVID-19 pandemic on HIV services,
> followed by a rapid recovery, CROI 2021 heard last week
> <https://www.aidsmap.com/news/mar-2021/resilient-hiv-programmes-african-countries-have-maintained-viral-suppression-during?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
> .
>
> Data were collected from October 2019 to September 2020 from health
> facilities which ICAP at Columbia University provides technical support to,
> with funding from PEPFAR. COVID-19 control measures were introduced in most
> countries in March 2020, at the end of the second quarter analysed.
>
> Comparing January-March and April-June, there was a 3.3% decline in the
> number of people tested for HIV, a 9.5% decline in the number of people
> with a positive diagnosis and a corresponding 9.8% decline in people
> starting HIV treatment.
>
> In the following quarter (July-September), there was a rapid rebound, with
> testing up 10.6%, positive diagnoses up 9.0% and people starting treatment
> up 9.8%.
>
> The overall number of people receiving antiretroviral therapy did not
> decline during the year and in fact rose steadily, from 419,028 to 476,010.
> Throughout, over 60% received viral-load testing and viral suppression
> increased – from 87.5% to 90.1%.
>
>    - *Read this news story in full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/resilient-hiv-programmes-african-countries-have-maintained-viral-suppression-during?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>*
>
>
> São Paulo patient has detectable viral load again
> [image: Dr Ricardo Diaz presenting to CROI 2021.]
> Dr Ricardo Diaz presenting to CROI 2021.
>
> A Brazilian man who last summer had no evidence of remaining HIV after
> more than 15 months off antiretroviral therapy once again had detectable
> viral load a few months later, the conference was told.
> <https://www.aidsmap.com/news/mar-2021/sao-paulo-patient-experiences-apparent-viral-rebound-year-and-half-after-stopping-hiv?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>
> In an effort to reduce the size of the HIV reservoir, the man had received
> an intensified drug regimen (five antiretrovirals and nicotinamide)
> followed by a closely monitored treatment interruption. At AIDS 2020, it
> was reported that he had undetectable HIV RNA, undetectable HIV DNA and low
> HIV antibody levels.
> <https://www.aidsmap.com/news/jul-2020/brazilian-man-long-term-hiv-remission-without-stem-cell-transplant?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>
> However, a few months after that, cell-mediated immune responses
> progressively disappeared. He also developed a range of symptoms and had
> detectable RNA again.
>
> The emerging HIV strain had genetic differences compared with the baseline
> strain, and the reason for this is not yet clear. Possibilities include
> viral evolution within the patient's body, reinfection with a new strain or
> re-emergence of a different strain from prior dual infection.
>
>    - *Read this news story in full on aidsmap.com*
>    <https://www.aidsmap.com/news/mar-2021/sao-paulo-patient-experiences-apparent-viral-rebound-year-and-half-after-stopping-hiv?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>
>
> Gender-affirming surgery associated with sustained viral suppression
> [image: Dr Cristina Rodriguez-Hart (right) presenting at CROI 2021.]
> Dr Cristina Rodriguez-Hart (right) presenting to CROI 2021.
>
> Viral suppression among transgender people enrolled in Medicaid living in
> New York City went up after receiving gender-affirming surgery, according
> to research presented to CROI 2021
> <https://www.aidsmap.com/news/mar-2021/gender-affirming-surgery-associated-sustained-viral-suppression?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>.
> Gender-affirming surgery was associated with improved viral suppression
> among groups who tend to have low rates of viral suppression – Black,
> young, transgender people living in very high poverty areas.
>
> Researchers compared viral suppression outcomes among transgender people
> accessing Medicaid who received any form of gender-affirming surgery, those
> not accessing Medicaid and cisgender men and women.
>
> Of the 1730 transgender people living with HIV enrolled in Medicaid, just
> under 11% accessed gender-affirming surgery during the study period.
>
> For transgender people enrolled in Medicaid, there was a 13% increase in
> viral suppression between 2013 and 2017, with 75% achieving viral
> suppression by 2017. However, viral suppression for this group on the whole
> remained lower than transgender people not enrolled in Medicaid (83%),
> cisgender women (82%) and cisgender men (86%).
>
> Transgender people who received gender-affirming surgery were the
> exception: by 2017, 85% had achieved viral suppression. In this group, 57%
> were Black, 22% were aged 20-29 and 44% lived in high poverty areas.
>
> Viral suppression went from 66% two years before surgery to 77% one year
> before. It increased to 86% one year after surgery and remained high at 88%
> two years after surgery.
>
> Anecdotal evidence suggests surgeons commonly require individuals to be
> virally suppressed prior to surgery. The data suggest that viral
> suppression that is achieved is sustained over time.
>
> Two studies presented at CROI 2021 looked at the interaction between
> gender-affirming hormone therapy (GAHT) and HIV pre-exposure prophylaxis
> (PrEP).
> <https://www.aidsmap.com/news/mar-2021/prep-does-not-lower-hormone-levels-young-transgender-people-lower-prep-levels-seen?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
> In both studies, young trans men and women aged 16-24 who were already
> taking GAHT – half of them women taking oestrogen and half of them men
> taking testosterone – then started taking directly observed daily oral PrEP
> using tenofovir/emtricitabine.
>
> The first study focused on levels of GAHT and provided reassurance that
> levels are not significantly lower, either in men or women.
>
> The second study looked at the effect of GAHT on PrEP levels. Although
> intracellular levels of the PrEP drugs tenofovir disoproxil fumarate and
> emtricitabine were lower in trans women than in trans men, they were still
> within the range of levels seen in similar studies of directly observed
> PrEP conducted in cisgender people.
>
>    - *Read the viral suppression story in full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/gender-affirming-surgery-associated-sustained-viral-suppression?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    *
>    - *Read the PrEP and hormone levels story in full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/prep-does-not-lower-hormone-levels-young-transgender-people-lower-prep-levels-seen?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>*
>
>
> What are the roles of TAF and integrase inhibitors in weight gain?
> [image: Flotsam/Shutterstock.com.]
> Flotsam/Shutterstock.com.
>
> Tenofovir alafenamide (TAF) was linked to weight gain in three large
> studies of people changing HIV treatment presented at CROI 2021
> <https://www.aidsmap.com/news/mar-2021/what-are-roles-taf-and-integrase-inhibitors-weight-gain?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>.
> Each study identified TAF as a contributor to weight gain but produced
> conflicting findings on the role of integrase inhibitors.
>
> TAF in combination with emtricitabine is included in several of the more
> commonly prescribed antiretroviral combinations and it has emerged in
> several studies as an independent risk factor for weight gain.
>
> The three studies presented at CROI 2021 looked at people who changed
> treatment, not people just starting treatment, so any ‘return to health’
> effect of starting treatment can be ruled out.
>
> An analysis from the RESPOND cohort study covered 14,703 people in Europe
> and Australia.
>
> Participants were followed for a median of 2.6 years and just over half of
> participants (54%) experienced a weight gain of at least 7% of body mass
> index (BMI). Four antiretroviral drugs were associated with an increased
> odds of weight gain in multivariate analysis: the integrase inhibitors
> dolutegravir and raltegravir, the non-nucleoside reverse transcriptase
> inhibitor etravirine, and TAF, a nucleotide reverse transcriptase inhibitor.
>
> The odds of weight gain associated with dolutegravir and TAF were higher
> when the two drugs were used together, but both dolutegravir and TAF were
> independently associated with higher odds of weight gain of at least 30% of
> BMI.
>
> To investigate how prior tenofovir use, or a switch from TDF to TAF,
> affected weight gain in people taking an integrase inhibitor, Professor
> Grace McComsey and colleagues looked at 2272 people receiving HIV care at
> major clinics in the US and London.
>
> All participants were virologically suppressed and switched to a new
> integrase inhibitor regimen, including 64% who had previously been on a
> different integrase inhibitor. Forty-seven per cent switched from TDF to
> TAF at the same time. Participants gained an average of 1.3kg in the year
> following the switch, with no difference in mean weight gain between
> integrase inhibitors.
>
> Weight gain of at least 10% was more likely in women, people underweight
> or normal weight at baseline, those switching from a prior non-integrase
> regimen and those switching from TDF to TAF.
>
> An analysis of the US HIV Outpatients Study found that switching to an
> integrase inhibitor was independently associated with weight gain and that
> the greatest weight gain occurred in the first eight months after
> switching. Thereafter, further weight gain was largely attributable to TAF
> use.
>
>    - *Read this news story in full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/what-are-roles-taf-and-integrase-inhibitors-weight-gain?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    *
>
>
> Four-days-on, three-days-off treatment regimen still looks effective after
> two years
> [image: Dr Roland Landman presenting to CROI 2021.]
> Dr Roland Landman presenting to CROI 2021.
>
> Taking antiretroviral medication four consecutive days each week followed
> by a three-day break maintained viral suppression as well as a daily
> regimen, according to 96-week follow-up results presented at CROI 2021
> <https://www.aidsmap.com/news/mar-2021/four-days-three-days-treatment-regimen-still-looks-effective-after-two-years?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
> .
>
> In the era of effective antiretroviral therapy, efforts are underway to
> enable people with HIV to take medications less often. The QUATOR study
> investigated whether people with an undetectable viral load could maintain
> viral suppression while taking medications just four days a week. If
> successful, this approach would not only give people breaks from treatment,
> it could also reduce the cost of therapy by about 40%.
>
> The study participants were using a variety of different antiretroviral
> regimens. Just under half (48%) were taking an integrase inhibitor, most
> commonly elvitegravir or dolutegravir; 46% were using a non-nucleoside
> reverse transcriptase inhibitor (NNRTI), most commonly rilpivirine; and 6%
> were on a protease inhibitor, most often darunavir.
>
> For the first 48 weeks, 636 participants were randomly assigned to either
> remain on the same daily treatment regimen or to take their current
> medications for four consecutive days (Monday to Thursday) followed by
> three days off. From week 48, both groups followed the four-days-on,
> three-days-off schedule for another 48 weeks.
>
> After 96 weeks, 92.7% of people who were initially randomised to the
> four-day group and 96.1% of those who switched from daily to intermittent
> treatment still had an undetectable viral load. Virological failure rates
> rose to 4.2% and 2.0%, respectively. However, in the four-day group, this
> differed according to the drugs used: 5.3% for those taking NNRTIs and 2.4%
> for those taking integrase inhibitors.
>
> New drug resistance mutations were detected in seven of the 19 people who
> experienced virological failure on the four-days-on regimen.
>
> The researchers concluded that the efficacy of the four-days-on,
> three-days-off regimen was sustained at 96 weeks with a low rate of
> virological failure, particularly among people using integrase inhibitors.
>
>    - *Read this news story in full on aidsmap.com
>    <https://www.aidsmap.com/news/mar-2021/four-days-three-days-treatment-regimen-still-looks-effective-after-two-years?utm_source=conference+news-english&utm_medium=email&utm_campaign=2021-03-17>
>    *
>
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