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

Sat Mar 20 16:50:29 PDT 2021

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_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_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_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_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_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_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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