Stopping ART safely if your clinic is closed or runs out of meds: a practical guide

24 March 2025. Related: Early access, Special reports, Treatment strategies.

Simon Collins HIV i-Base

This draft article will be updated shortly with graphics.

Introduction: A crisis no-one expected
How does ART work?
Being diagnosed early or late
The first period of ART meds: from 1995 to 2015
Modern ART: from 2016 to 2025
Measuring our immune system: CD4 count and viral load
What happens if ART is stopped?
Who is at higher risk from stopping ART?
What if I am at higher risk from stopping ART?
What about post-treatment controllers?
What is the safest way to stop ART?
Which symptoms are most serious after stopping ART?
How can I protect my health if I am not on ART?
Can I make my meds last longer by taking fewer doses?
Staying connected to care
Further information

1. Introduction: A crisis no-one wanted or expected

This article includes information in case some people living with HIV have to stop treatment. For example, if the HIV clinic is closed or runs out of medicines.

This is only for an emergency situation that we hope will only be for a short time.

Since January 2025, changes to US international funding forced HIV clinics in many countries to close overnight. Some people had to stop treatment without even seeing a health worker. This is a crisis that none of us expected. [1, 2]

It might take some countries time to find new ways to provide ART. Also, even when some grants are saved, HIV services might still be disrupted for a while. [3]

For anyone currently on ART, the idea of having to stop treatment is very stressful. We know it is important to be on ART. We take this seriously. We know that we need to not miss doses. This is for our own health and also protects our partners if they are HIV negative.

Although these things are all true, and it would be better to stay on treatment, stopping ART for a short time will only be a low risk for many people.

This article explains the different risks involved for different people. It includes why stopping ART will sometimes be safe and sometimes a high risk.

The information in this article might be needed now or in a future emergency. For example, if your clinic runs out of meds, or needs to change your meds, or if your government takes a few months to organise funding.

It also includes information about how to safely stop ART and how to restart. How to know whether this might be a high or low risk. Also, options for how to make HIV meds last longer.

Although it is not ideal, many people are working hard to find ways to make sure that any break in ART will just be for a short time.

2. How does ART work? (ART = HIV treatment)

Modern ART in 2025 is so effective that it is recommended for everyone living with HIV.

ART works as soon as you start taking your meds.
It quickly reduces viral load, usually to undetectable.
Your immune system then steadily becomes stronger.
Taking meds on time can then keep viral load undetectable.

Treatment is now much better than the first HIV meds. This also makes them safer if we do need to stop ART.

The meds are better at staying in our bodies for a little longer. This means that if we sometimes miss a dose we will still be ok.
The risk of drug resistance is also much lower than with the first HIV meds.

3. Being diagnosed early or late

There are three main times when people find out they are living with HIV: early, after a few years, or much later.

This is one of the things that affects how safe it is to stop ART.

Having an idea of which group you are in will help you know your risk if you stop ART.

However, there isn’t a test to show how long we have been living with HIV. So which group we are in is often just a rough guess.

Knowing your first CD4 count and viral load can sometimes help.

For example, when not on treatment, the CD4 count can drop by 50-100 cells every year.

However, we also respond to HIV in different ways. Some people progress more quickly and other people can stay well for many years.

Group 1: Diagnosed early

Some of us were diagnosed soon after we became HIV positive, in early infection. This is generally defined as within 6 to 12 months.

Group 2: Diagnosed after several years

Most of us only find out we’ve been living with HIV much later. This could be maybe 1 to 5 years after becoming HIV positive.

Group 3: Diagnosed late with advanced HIV

Many people, often still about half of us, are diagnosed much later. This can be when HIV is more advanced and after we are already becoming ill.

4. The first period of ART meds: from 1995 to 2015

The first HIV meds were much more difficult to take than the meds we take now.

The drugs were not as effective against HIV. They needed many pills and many doses. They also had more side effects. They needed very careful adherence and missing doses could easily cause the meds to fail with drug resistance.

Treatment guidelines were strict in saying to take every dose on time.
Side effects meant that it was sometimes okay to wait before starting ART.

This means we know that many people can be well and healthy if the current crisis means that ART needs to be stopped for a short time.

But safely stopping ART involves having a good immune system. For example, being in Group 1 or 2 above. The risk of stopping ART will be higher for people in Group 3 who were diagnosed late.

5. Modern ART: from 2016 to 2025

Since 2016, modern HIV drugs have been much better. This is especially true for the most widely used combination called TLD.

TLD includes tenofovir, lamivudine and dolutegravir.

ART often only involves one pill a day for a whole combination.
ART has fewer side effects.
The meds stay at safer levels in our bodies for a longer time.
The meds are now less likely to cause drug resistance.

The better meds also made it easier for everyone to start ART, soon after getting a positive HIV test.

Since 2016, WHO guidelines have recommended ART for everyone living with HIV. This includes people who are diagnosed very early and who still have a strong immune system. Before this, the guidelines said that some people could wait before starting ART. [4]

These new recommendations were because of a study called START.

START showed that early ART roughly halved the risk of serious health complications even in people with a strong immune system.

But START also showed that the absolute risk of these complications was low. In more than 4600 participants followed for an average of three years there were only 36 more serious AIDS events and only 18 more serious non-AIDS events in the people not on ART.

However, the results were in people in early HIV with a strong immune system. They show that people who were diagnosed in Groups 1 and 2 or who now have a good immune system, might only be at a low risk from stopping ART for a few months.

6. Measuring our immune system: CD4 counts and viral load

For many years, everyone diagnosed HIV positive used to have a CD4 test.

The CD4 results showed how much HIV had affected our immune system.

Having a higher CD4 count meant our immune system was still very strong. For example, if the CD4 count was above 350, or 500 or even higher.

Having a lower CD4 count meant we were at higher risk of becoming ill. For example, if the CD4 count was below 200, 100 or even less than 50.

If you remember your CD4 count, this will be important when discussing the risk of stopping ART.

But if you didn’t have this test or can’t remember the result this is also okay. Also, over the last five years many clinics stopped using the CD4 test.

This was because ART makes most people get a stronger immune system. The money saved on not using CD4 tests was used to pay for ART.

If you never had a CD4 test or if you can’t remember the result then knowing about your viral load results can help.

If you ever had a viral load result that was higher than 50,000, this might mean your CD4 count was less than 500. This is just a very rough guide though and might not work if you were diagnosed soon after becoming HIV positive.

7. What happens if ART is stopped?

Early HIV research can also tell us what to expect now if ART is stopped. About 20 years ago many studies looked at taking a break in ART to avoid side effects. These were generally in people who had a good CD4 count higher than 250 cells/mm³.

It took a very large study called SMART to then show that this was not a good idea. SMART showed that it is better to stay on continuous ART. But it also showed that for many people, taking a short break in ART, even for a few months, was generally safe. [5]

If someone with an undetectable viral load stops ART, it can cause the following response.

Viral load will stay undetectable for the first 1-2 weeks.
After these two weeks, viral load will rebound more quickly. It can also rebound to much higher levels, including to higher than 100,000 copies/mL.
Stopping ART can sometimes cause new symptoms. A health worker needs to know about any new symptoms to decide whether this is because of your viral load or CD4 count. The symptoms might be because of a high viral load or because your CD4 count has dropped.
Even with a high viral load, your CD4 count can still stay high for many months. The longer you were on ART before stopping ART, the stronger your immune system will be.
After stopping ART, your immune system will steadily go back to the level it was when you were first diagnosed. Stopping ART is a higher risk for people who were diagnosed late.
The high viral load after stopping ART will mean that U=U will no longer work. When not on ART, we need to be more careful if we have sex with anyone who is not living with HIV. Using condoms with partners who are HIV negative will protect them from HIV.

8. Who is at higher risk from stopping ART?

The following people will be at higher risk from stopping ART.

Anyone in Group 3 who was diagnosed late. (See Section 2).
Anyone who had a CD4 count that was lower than 200.
Anyone who was ever seriously ill with HIV.
Anyone who was ever diagnosed with AIDS.

As well as these factors, some people should never stop ART.

Anyone who is pregnant.
Younger children and adolescents.
Anyone with serious symptoms, whether from HIV or another infection.
Anyone currently being treated for another serious infection.

9. What if I am at higher risk from stopping ART?

Options for continuing to access ART are likely to be different in each country or region.

This might depend on the type of clinic where you were getting your care. For example, if your local clinic is closed, you should be able to access ART at a government hospital.

For example, if your local community clinic is closed, this might mean traveling to a government clinic in a larger town or city.

Even though the government clinic might not be so friendly, if you are at higher risk, please find a way to stay connected to care. It is important that a health worker knows about you and can continue to prescribe ART.

People at a high risk from stopping ART need to find a way to continue treatment.

This is because the risk of HIV when not on ART is more urgent.

Perhaps visit the hospital with a friend for support.

10. What about post-treatment controllers?

A few people might be very lucky when they stop ART.

Several studies showed that maybe 1 in 20 people can have a very strong immune response if they stop ART. [6]

This response is more likely in people in Group 1 (see above) who were diagnosed soon after becoming HIV positive. This also involves having started ART soon after becoming positive.

Some people keep viral load undetectable for more than a year after stopping ART.

However, there is no way to tell who will get this response. This is why staying connected to care is important.

11. What is the safest way to stop ART?

If your meds run out and you are not at high risk, it is better to stop all your meds at the same time.

For people on a single pill combination, this will just mean stopping the daily pill.

If your HIV meds include several separate drugs, it is best to stop them all on the same day.

Even if you still have some of your meds left over, don’t take them without the full combination.

After stopping ART, please stay in contact with your clinic so you know when ART becomes available again. When ART becomes available again, it will be okay to restart at the same times as before.

Hopefully any time off ART will be short.

Please also watch out for new symptoms though and tell a health worker about this (see below).

12. Which symptoms are most serious off ART?

Any new symptoms after stopping ART might be linked to either (i) having a higher viral load or (ii) having a lower CD4 count.

This is why it is important to take new symptoms seriously.

The more serious the symptoms are, the more important it is to see a health worker.

For example:

Any new persistent cough that continues and doesn’t go away.
Any difficulty breathing, or breathing more heavily.
A high temperature or fever that doesn’t respond to paracetamol or that persists for several days. A normal temperature is about 37°C.
New skin problems or a serious rash. For example, any rash that breaks the skin or that covers more than 5% of your body.
Unexplained significant weight loss. For example, losing more than 5% body weight over 6 months.

Small changes in how you feel might just be related to everyday life though. For example, if you are stressed and not sleeping well or if you catch a regular cold.

So keeping a balance is important and speak to a health worker if you are worried.

13. How can I protect my health if I am not on ART?

If anyone has to stop ART, it is good to take extra care with other ways to look after your health.

Try to keep a positive mind and focus on things getting better in the future.
Focus on things that are generally good for your health.
Try to stay physically active. This is as good for your mind as your body.
Try to eat a nutritious and balanced diet.
Keep mentally active and keep a positive outlook on life.
Try to keep a good support network with friends and family – and support other people who might be more isolated.
Try to minimise stress in your life.
Try to make sure you sleep well.
Try to limit things that are generally not healthy, like cigarettes, alcohol and recreational drugs.

Changing to a healthier lifestyle is not a replacement for ART.

However, this might help you stay well until you are able to restart ART.

14. Can I make my meds last longer by taking fewer doses?

Modern ART is now good enough to cover us if we are sometime late or miss a dose.

If meds are still available, then daily ART is still best.

But the meds in modern ART are now good enough for some people to use less than seven doses every week. Several studies, including some discussed below, showed that taking fewer doses each week can be safe.

This could let some people save a few meds each week to have an emergency supply.

Please remember this is a response to an emergency situation when the supply of ART is uncertain.

The strongest data shows that taking only five doses a week can be just as effective as taken seven daily doses. Many of the people in these studies had very strong CD4 counts and had had an undetectable viral load for many years.

Many studies were with older HIV drugs though, mainly based on efavirenz. Modern ART based on integrase inhibitors could produce better results, but we don’t have these studies. But other studies are still running and should report results later in 2025.

5-on 2-off (Five On Two Off – FOTO dosing)

Several small studies produced very good results from taking ART every day from Monday to Friday but not taking ART on Saturday or Sunday.

They found no differences in viral load in people using this schedule compared to daily ART over a year. Saving two doses a week would save 8 doses a month and 96 doses over a year. Those 96 doses would provide another 20 weeks of ART and make 52 weeks of meds last for 72 weeks.

These studies have several cautions.

Viral load needed to be undetectable for at least a year.
The studies only enrolled people who had never been seriously ill from HIV. For example, they had CD4 counts starting higher than 350.
These were people who were on their first HIV treatment, with no drug resistance.
Some studies excluded people with hepatitis B. This is because ART also treats hepatitis B. This is now thought to be okay with slightly fewer weekly doses.

A few studies have reported that four doses a week might also be safe but there is much less data about this. If safe, this would make 52 weeks of daily meds last for 91 weeks.

All these studies required people to have had an undetectable viral load for at least 12 months, but in practice in some studies people have been undetectable for many years, which might have helped get good results.

Summary of research for reduced dosing

The original 5-on 2-off studies were run in the US and included a pilot study in 30 participants with a CD4 count >200 and no previous failure on efavirenz-based ART. A second study included 60 participants, but 24-week results only seem to have been presented at conferences and so there are limited details. Both studies used efavirenz-based ART. During the year of the study there were no differences compared to daily ART. [7, 8]

A short-cycle interruption study of 112 people in Uganda taking either PI- or efavirenz-based ART enrolled participants with a CD4 count of >125 or higher. [9]

Using a lower CD4 count for people to enter the study makes the results more relevant for other African countries. For example, the median CD4 count was only about 260 and people had only been on ART for about a year.

This study also included a group who alternated being on ART for a week and then off ART for a week which definitely didn’t work. People using 5-on 2-off though did just as well as people taking ART seven days a week.

There were no differences in results in the 5-on 2-off group compared to daily ART.

The BREATHER was in 199 children and adolescents on first-line ART with no history of drug resistance and who had CD4 counts of >350. There were no differences in results in the 5-on 2-off group compared to daily ART. [10]

Hopefully, services for children and young adults will be given priority to continue to be funded. These data are reassuring in an emergency though.

The most recent version of 5-on 2-off randomised 60 people to 5-on 2-off vs daily ART using an integrase inhibitor-based combination called Biktarvy. This combination is similar to TLD, but also has some differences. This study from Taiwan needed a higher baseline CD4 count of >350 and reported no differences between the two groups out to 48 weeks. [11]

Taking ART every second day

A Spanish study looked at only taking ART on every other day. [12]

This study enrolled 197 people who had been undetectable on ART for at least six months and randomised half to take treatment every second day and half to stay on daily treatment.

These people had very good CD4 counts and they had never been very low in the past. The median CD4 cell count was above 650 cells/mm³. Half the participants (IQR) had a CD4 count between 525 to 814. The lowest ever CD4 (called the nadir) was 270 (IQR: 217 to 339). The people in this study had also been undetectable on ART for roughly five years (IQR: 3 to 9 years) and on efavirenz-based ART for roughly 3 years (IQR: 2 to 4.5).

Over one year, three people had viral failure in the alternate treatment group compared to one failure in the group taking ART every day. However, drug levels of efavirenz became much lower in the alternate dosing group.

Adherence would also be more complicated using this approach and so this is not as good as 5-on 2-off dosing.

Studies using four or fewer doses a week

Several other studies have looked at whether using only four doses a week might be okay. This is more difficult to recommend though because drug levels in some people are likely to drop below the minimum target levels.

Also, compared to the weekdays vs weekends routine with 5-on 2-off, it might be more difficult to remember which days you need to take meds and whether or not you have missed doses.

The largest of these studies was a French study called QUATUOR. It randomised almost 650 people to either 4-on 3-off or daily ART. Everyone needed to be on their first combination with a CD4 count >250, and not have drug resistance or hepatitis B. [13]

Over two years there was no significant difference between the two groups including for viral blips.

These results were good enough for the French HIV guidelines in 2024 to include that some people could use the option of only taking 4 or 5 daily doses each week. However, the good results might have been because many people had been undetectable on ART for almost 6 years (IQR: 3.3 to 9.6 years) and had very good adherence to ART.

Finally, a recent Spanish study randomised 40 people to four groups taking ART 7, 3, 2 or 1 day a week. People in this study all had CD4 counts higher than 350. The average CD4 count (median) was 635 (IQR: 517 to 762) and people had been diagnosed and likely been on treatment for 8 years (IQR: 4 to 12).

Although most people in the reduced dosing groups did very well over a year, drug levels dropped to very low levels and using such reduced dosing is not recommended. The study did however produce evidence from using integrase inhibitor based-treatment ART, which showed it could easily be effective for 5-on 3-off dosing.

Alternating one week on and one week off does not work

It is also important to say that several studies showed that switching each week between 7 days on and 7 days off was a very bad idea.

This did not work and people were at a high risk of their treatment quickly failing. [9]

Definitely do not try this.

Also, the options above all use the full-strength medicines.

Please never try to cut pills to get lower doses.

15. Staying connected to care

Even if your clinic is closed or if you have to stop ART, please stay connected to care.

Please find a way to register at a new clinic and stay connected to a health worker.

One of the fears about the recent changes is that some people might just disconnect from care.

This is not a good idea.

Even if you have to stop ART for a short time, your health worker needs to know about this. Although a short break in ART might be okay, HIV won’t have gone away.

Your health is too important and things will get better.

If you are lucky to still have access to ART and still have several months left, please talk to a health worker about whether reduced dosing might help.

16. Further information

This article was written as a response to changes in international funding in the first months of 2025.

This is a situation that is still changing every week. Please keep in touch with your HIV clinic and with HIV organisations in your country.

Hopefully, international funding will still continue and each country will find new ways to continue to provide HIV treatment.

An international network of HIV activists is tracking and reporting on news and changes about access to ART.
https://pepfarwatch.org/pepfar-funding-freeze/

CHANGE organised a recent webinar on the safety and risks of having to stop ART because of changes in US funding. This includes a review of the evidence by Dr Sanjay Bhagani and community discussion with leading doctors from WHO.

This webinar is available to watch online and the slides can be downloaded.
https://i-base.info/stopping-art-if-your-clinic-is-closed-practical-facts-about-safety-and-risk

i-Base also publishes news and links to important developments.
https://i-base.info/pepfar-news-and-links

Simon Collins is a treatment advocate at HIV i-Base in London. He has been living with HIV for more than 35 years. He has been on ART since 1996 which he started when his CD4 count was less than 10 cells/mm³.

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