[Viva] Fwd: Long-acting injectable drug prevents HIV

Wed May 27 08:10:11 PDT 2020

---------- Forwarded message ---------
From: CATIE News <mailer at catie.ca>
Date: Wed, 27 May 2020, 7:58 am
Subject: Long-acting injectable drug prevents HIV
To: <deniseswozniak at gmail.com>

Doctors studied a new HIV prevention drug that is injected into the muscle
every two months
COVID-19 Resources
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=895856c111&e=14dd36bd6f>
[image: CATIE News]

View this e-mail in your browser
<https://mailchi.mp/catie/long-acting-injectable-drug-prevents-hiv?e=14dd36bd6f>
Long-acting injectable drug prevents HIV

   - *Doctors studied a new HIV prevention drug that is injected into the
   muscle every two months*
   - *4,500 gay and bisexual men and transgender women entered the clinical
   trial of injectable cabotegravir*
   - *The drug was found to be generally safe and significantly reduced the
   risk of HIV infection*

[image: Share]
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=d2588fc1e1&e=14dd36bd6f>
Share
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=419649fbe5&e=14dd36bd6f>
[image: Tweet]
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=be95958c2a&e=14dd36bd6f>
Tweet
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=fd89f9029f&e=14dd36bd6f>
[image: Forward]
<http://us16.forward-to-friend.com/forward?u=89abcbccf295c7b8d9a92cf09&id=2048a767a9&e=14dd36bd6f>
Forward
<http://us16.forward-to-friend.com/forward?u=89abcbccf295c7b8d9a92cf09&id=2048a767a9&e=14dd36bd6f>

Taking anti-HIV drugs prior to possible sexual exposure in order to reduce
the risk of acquiring HIV infection is called pre-exposure prophylaxis
(PrEP). Truvada, a pill containing two anti-HIV drugs (tenofovir DF + FTC),
is approved as PrEP in Canada and many other countries. It is also
available in generic formulations. A majority of clinical trials have
tested Truvada as PrEP when taken as one pill every day. However, some
clinical trials have found that taking it less frequently, on a schedule
called “on-demand,” can also significantly reduce the risk of HIV infection.

Some people dislike taking pills and/or may not remember to take them.
Pharmaceutical companies are developing drugs for PrEP that need infrequent
dosing.
Long-acting PrEP

The pharmaceutical company Viiv Healthcare is developing a form of
long-acting PrEP with a drug called cabotegravir. The drug is injected into
muscle every two months. Long-acting cabotegravir is slowly released from
muscle into the blood.
Study HTPN 083

The U.S. National Institutes of Allergy and Infectious Diseases (NIAID)
sponsored a study called HPTN 083. This study recruited 4,570 HIV-negative
people—mostly gay and bisexual men; about 12% of participants were
transgender women. The study took place in South America, South Africa,
Southeast Asia and the United States.

For the first five weeks of the study, participants took orally a
combination of cabotegravir tablets and placebo Truvada tablets. This
lead-in period was to ensure that participants did not develop side effects
from cabotegravir. At the end of this time, participants were randomly
assigned to receive one of the following interventions:

   - long-acting cabotegravir injection + daily placebo Truvada pills
   - injections of placebo + daily Truvada pills

Neither the participants nor clinic personnel knew who received which drug.
The study began in December 2016.
Interim results

According to NIAID, a recent review of the study’s results by an
independent data and safety monitoring board (DSMB) found that “long-acting
cabotegravir was highly effective at preventing HIV in the study
population.”

Some people became HIV positive during the study. These infections were
distributed as follows:

   - long-acting cabotegravir – 12 people
   - Truvada – 38 people

Statistically, this suggests that cabotegravir was as effective as Truvada.
Although the study was originally designed to show the superiority of
long-acting cabotegravir, when the COVID-19 pandemic occurred it became
increasingly difficult for participants to keep clinic appointments and
many trial sites had to close. As a result, the scientists operating the
trial decided to change the primary aim: to show that long-acting
cabotegravir was as effective as daily Truvada.

Scientists involved with the study are planning an investigation to
understand why some people who took long-acting cabotegravir or daily
Truvada became infected.

After its analysis, the DSMB recommended that all participants get the
results and are offered injectable cabotegravir.
Side effects

According to NIAID, both long-acting cabotegravir and Truvada were
“generally safe and well tolerated.” Most people (80%) who received
long-acting cabotegravir reported temporary pain and tenderness at the
injection site vs. 31% of people who received injections of placebo.
A trial in women

Another clinical trial called HTPN 084 has enrolled more than 3,000
HIV-negative heterosexual women. This trial began about a year after the
previous study and will also investigate the safety and effectiveness of
long-acting cabotegravir. Study HTPN 084 has recruited participants from
East and Southern Africa. The DSMB has looked at the interim data and
recommended that it continue.
For the future

Detailed results from study HTPN 083 will be released at a future
scientific conference. Long-acting cabotegravir for the prevention of HIV
infection will likely be approved in Canada and other high-income countries
and regions sometime over the next two years.

Viiv is developing plans to facilitate access to long-acting cabotegravir
in low- and middle-income countries. However, it will probably be several
years before those plans are implemented.

The results from HTPN 083 mark a major milestone in the HIV pandemic. The
eventual regulatory approval of long-acting cabotegravir will result in
more options for HIV prevention. It will also spur pharmaceutical companies
to develop even longer-acting formulations of PrEP.

*–Sean R. Hosein*

*Resources*

Oral pre-exposure prophylaxis (PrEP)
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=b88eb40b9d&e=14dd36bd6f>
–
CATIE fact sheet

How does PrEP prevent HIV?
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=b190d06143&e=14dd36bd6f>
–
CATIE video

PrEP resources and tools
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=4f05ecf694&e=14dd36bd6f>

REFERENCES:

   1. NIAID. Long-acting injectable drug prevents HIV among men who have
   sex with men and transgender women. *Press release*. 18 May 2020.
   2. Cohen J. Long-acting drug acts like a short-term AIDS vaccine.
   *Science*. 22 May 2020.

[image: Facebook]
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=113581f5b0&e=14dd36bd6f>
[image: Twitter]
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=fd24b3370a&e=14dd36bd6f>
[image: YouTube]
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=e9aaad6bde&e=14dd36bd6f>
[image: Instagram]
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=ce2b5c3df7&e=14dd36bd6f>
[image: LinkedIn]
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=f4b28d7943&e=14dd36bd6f>
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=862d3bd8c1&e=14dd36bd6f>

*Our mailing address is:*
CATIE 555 Richmond St. West Suite 505 Toronto, On M5V 3B1 Canada

Want to change how you receive these emails?
You can update your preferences
<https://catie.us16.list-manage.com/profile?u=89abcbccf295c7b8d9a92cf09&id=ae993f6577&e=14dd36bd6f>
or unsubscribe from this list
<https://catie.us16.list-manage.com/unsubscribe?u=89abcbccf295c7b8d9a92cf09&id=ae993f6577&e=14dd36bd6f&c=2048a767a9>
.

Privacy
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=91348f4277&e=14dd36bd6f>
| Disclaimer
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=4f059cbf94&e=14dd36bd6f>
| Permission to reproduce
<https://catie.us16.list-manage.com/track/click?u=89abcbccf295c7b8d9a92cf09&id=8886079e29&e=14dd36bd6f>
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lists.resist.ca/pipermail/viva/attachments/20200527/55bf9bbc/attachment-0001.html>