AIDS ACCESS FOUNDATION/ MSF AIDS can be Treated: A handbook of Antiretroviral medicines. AIDS Can Be Treated. A Hand Book of Antiretroviral medicines

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1 AIDS Can Be Treated A Hand Book of Antiretroviral medicines The translation of this booklet is due to support from the Working Together Regional Training Project of the AIDS Access Foundation, Bangkok Thailand, and the collaboration with MSF, Belgium Thailand Text by: AIDS ACCESS Foundation & MSF Belgium Produced by: AIDS ACCESS Foundation 48/282 Center Place, Ramkamhaeng Road, Sapansung District Bangkok Tel Fax access@:-aidsaccess.com website:

2 AIDS Can Be Treated AIDS ACCESS FOUNDATION/ MSF Recent progress in AIDS treatment means that it is no longer an illness with out hope. New medicines (ARV) are constantly being developed so that today we can say that HIV has become a chronic but manageable disease. People who only a few years ago suffered prolonged illness and thought that they would never live a long and active life are now taking ARV medicines which have returned them to health so that they are able to work, care for their families and enjoy life once again. If you are considering taking ARV medicines you must get reliable information about these drugs so that you can make the correct decision about your treatment and be sure that you will gain the full benefit of the treatment. You must also be aware that there are some people who will give you incorrect and misleading information and may offer to sell you fake or useless medicines for their own profit. Therefore we strongly advise you to seek help from a reputable hospital which has doctors with experience in treating people with HIV/AIDS. We hope that this small book will help you make correct choices about how to manage your disease and that you too will be able to benefit from the recent medical advances in the treatment of HIV/AIIDS. Facts about ARV medicines that you should be aware of 1. Currently there are no medicines existing that can cure AIDS but if taken correctly ARV medicines can control the HIV virus and allow you to lead a normal healthy life. 2. ARV medicines do not prevent or cure opportunistic infections. Prevention and treatment of opportunistic infections is vital if you wish to remain healthy especially when immunity (CD4 count) falls to low levels. 3. There are several types of ARV medicine available so if a certain ARV medicine is not suitable for you; your doctor has the possibility to change the medicine so that you have a better response to treatment. 4. ARV medicines may not give positive results in the short term and you may suffer some side effects at the beginning of your treatment. Do not feel discouraged. If side effects become unbearable you should discuss a change of medicine with your doctor. 5. Despite the fact that ARV medicines have some limitations they are currently the best way of treating HIV/AIDS

3 Index 4 Know Your Body in Order to Understand How Antiretroviral (ARV) Medicines Work 7 Understanding How ARV Medicines Work 8 Among the Many Combinations of ARV Medicines That Are Available Which One Is Best for Me? 8 Recommended ARV combinations 8 Among the many combinations of ARV medicine which one will suit me best? 10 Women and ARV medicines 11 When to Begin ARV Treatment 11 It is never too late to begin ARV treatment 11 How to prepare yourself to take ARV medicines 11 Effective treatment calls for self-discipline 11 Drug allergies and side effects are not the same 14 How to Know the Treatment Is Working 14 What to do if you think your treatment is not working 15 Caring for yourself and others when on ARV treatment 15 Closing remarks 16 Contacts for further information 16 Cost of ARV medicines in Thailand 17 References - 3 -

4 Know your body in order to understand how antiretroviral (ARV) medicines work Before understanding how ARV medicines work, you need to know how the immune system in your body works and what HIV does to that system. Understanding immunity Our bodies are in constant contact with many kinds of infections through food and drink, through the air we breathe, through cuts and wounds in our skin etc. Most of the time our excellent immunity systems, equipped with several types of white blood cells, manage to fend off these germs keeping our bodies healthy. White blood cells eliminate and control the growth of germs in our bodies so that they cause no harm to the body systems. While your immune system is in perfect condition and working against the invading germs your body will remain healthy. However when the immune system is damaged it can no longer control the germs that cause disease and you will begin to suffer from illnesses caused by these germs. CD4 White blood cells directly destroy germs and create antibodies to destroy specific germs What are CD4 cells and why are they important? CD4 cells are one kind of white blood cells that are responsible for killing and controlling many types of infections and also creating antibodies that the body can use as weapons to fight against invading germs. It is possible to check the number of CD4 cells in your body using a blood test called a CD4 count. In a healthy person there are 700 or more CD4 cells in 1 micro-litre of blood (approx. a drop of blood). A person with a CD4 count below 350 is considered to have immune deficiency

5 How to stay healthy and maintain your immune system What Does HIV Do To Our Immune System? Once HIV enters the body it will use CD4 cells to reproduce more HIV virus and in the process will destroy the CD4 cells. An HIV positive person who is not yet sick is said to be asymptomatic. However as the amount of HIV virus in the body increases and the number of CD4 cells drops to a level where they can no longer eliminate or control the germs entering the body, a person is considered to be immune deficient or symptomatic. Once a person has reached the symptomatic stage they will begin to get some illnesses that they did not get before. The average period between infection with HIV and the symptomatic stage of infection is some 7 to 10 years. Illnesses caused as a consequence of immune deficiency are called opportunistic infections. Opportunistic infections are mostly caused by germs already living in the body but which did not cause any trouble until the immune system began to fail. CD4 cells have double genetic strands within the cell and up-like features on the surface of the cell. The HIV virus has a single genetic strand at its centre and round ended arms on the surface of the virus. The HIV virus cannot reproduce by cell division but by capturing CD4 cells. The cup-like feature on the surface of a CD4 cell is the perfect fit with the rounded arm on the surface of an HIV virus

6 1. HIV virus attaches to CD4 cell. 2. HIV penetrates into CD4 cell and changes its single genetic strand into a double genetic strand by using a substance called Reverse Transcriptase. 3. When HIV gets to the nucleus of CD4, it will start to divide up into long strands which are cut into shorter single strands by a substance called Protease. These short strands then reassemble themselves in to many new HIV cells. 4. HIV can easily mutate so it is difficult for white blood cells to find and destroy HIV. 5. Once CD4 cells have been used by HIV to create more HIV the CD4 cell will no longer function or will be destroyed. Common opportunistic infections are oral thrush, thrush in the oesophagus, OHL along the side of the tongue, PPE spots, TB, herpes zoster, recurrent genital herpes, PCP, toxoplasmosis causing brain abscesses, cryptococcal meningitis, and Penicilocis

7 Understanding Antiretroviral (ARV) Medicines The goal of antiretroviral treatment is to control the growth of the of HIV virus for as long as possible to enable our immune system to recover and for the CD4 count to increase to a level whereby they can keep the body free of opportunistic infections and prevent the development of AIDS. The Keys to Successful ARV Treatment Your doctor should choose a WHO recommended combination of three ARV medicines that are suitable for your treatment needs. Different combinations of medicines are available to suit different medical needs. Take your ARV medicines on time and regularly to avoid drug resistance and keep HIV under control. Current ARV medicines control, but do not cure, HIV/AIDS therefore they need to be taken lifelong to keep HIV under control. Regular medical check-ups are necessary to monitor side effects, such as liver damage, that may be a consequence of long term use of ARV medicines. How Many Kinds of ARV Medicines Are Available? At present there are over 20 kinds of ARV medicines. Each of these medicines is designed to interrupt the reproduction of HIV virus at one of three different stages. Here are the 3 groups of medicines. The NRTI Group Including AZT, ddi, d4t, 3TC, Abacavir The NNRTI Group Including Nevirapine (NVP) Efavirenz (EFV) The PI Group Including Saquinavir (SQV), Indinavir (IDV), Ritonavir (RTV) Nelfinavir (NFV) In Thailand, the Government Pharmaceutical Organization (GPO) can now produce ARV medicines including AZT,ddI in powder form, d4t, 3TC and nevirapine as well as GPO-VIR, a single tablet containing d4t, 3TC and nevirapine. The cost of one month s treatment with GPO-VIR is approximately US$ 30. All the medicines produced by the GPO have passed quality and efficiency tests and have yielded similar results to the medicines from the original producers. Because GPO ARV medicines are locally produced they have become much more affordable

8 Among the many combinations of ARV medicines that are available which one is best for me? Recommended ARV combinations At present the WHO recommends that a combination of 3 ARV medicines chosen from at least 2 of the earlier mentioned groups should be taken to effectively inhibit the growth of the HIV virus. Such a combination of 3 ARV medicines taken correctly could give protection from AIDS for up to 15 years. As the HIV virus can easily become resistant to ARV medicines you should never take only one kind of ARV medicine. In cases where 2 kinds of medicines from the NRTI group are used, drug resistance might develop within 1 to 3 years or there may be no benefit from the treatment if the person taking the medicines already has serious immune deficiency. Standard ARV combinations currently recommended by the World Health Organization (WHO) Three drug combination 2 medicines from the NRTI group and 1 medicine from the NNRTI group. Examples: Or d4t + 3TC + NVP d4t + 3TC + EFV AZT + 3TC + NVP 2 medicines from NRTI group and 1 medicine from PI group d4t + ddi + IDV/RTV* AZT + ddi + SQV/RTV* * A low dose of Ritonavir (RTV) is used to boost the power of Indinavir (IDV) or Saquinavir (SQV) Among the many combinations of ARV medicines available which one will suit me best? Different people need different combinations of ARV medicines for the following reasons: For people that have never taken ARV medicines (ARV naive) - 8 -

9 1. It is not always true that more expensive medicines are better at controlling HIV growth. According to the WHO the most effective combination consists of 3 kinds of ARV medicines. 2. AZT should under no circumstances be taken in combination with D4T as they reduce the activity of each other. 3. Check that other medicines you are taking do not interact with your ARV as this could result in ineffective treatment. For example: Rifampicine used for TB treatment reduces the activity of nevirapine. Clarithromycin used for treating MAC must not be taken in combination with efavirenz Birth control pills must not be taken in combination with efavirenz or any of the medicines from the PI group. Avoid taking methadone, the medicine used for treating drug addicted patients, in combination with efavirenz. 4. It is important to have regular blood tests to monitor for anaemia and problems with the liver and pancreas. If there is anaemia avoid using AZT. If there are problems with the pancreas avoid ddi and d4t. 5. Should there be a serious allergic reaction to your ARV combination then the medicine causing the reaction must be replaced by a different ARV medicine. 6. Severity and duration of side effects from the same kind of ARV medicine vary from one person to the other. 7. Choose the most suitable medicines for your medicine taking habits as different types of medicines have different dosage patterns. You need to take your ARV medicines on time and regularly. 8. Availability of alternative ARV medicines is necessary in case the first combination of ARV medicines is not suitable for you. What if you are one of those who have taken ARV in the past or are currently taking ARV treatment? (ARV experienced) If you have taken ARV in the past: The most important information you need to know is if you have developed resistance to the medicines you used to take. If so, the new ARV combination you are considering should not include those medicines. An assessment of the probability of drug resistance can be made by looking at how correctly you took your ARV medicines in the past. The probability of resistance increases when: 1. The medicines are not taken on time and regularly. This is the usual cause of ARV resistance. 2. The dosage of ARV is insufficient. 3. The combination taken is not effective, i.e. consists of one or two ARV medicines only. 4. The medicines are taken over a long period of time. If you are currently on ARV treatment: If you are taking a combination of 2 ARV medicines (dual therapy) and you are in good health with a stable CD4 count and no opportunistic infection, you may continue with the treatment. Consult with your doctor if your current combination does not meet WHO standards before changing the combination. Do not reduce, adjust or stop your ARV medicines before consulting with your doctor

10 Giving a true medical history is important for effective treatment. Women and ARV medicines There are several things a woman needs to consider either before starting or during their ARV treatment. Birth Control Contraceptive pills are not a suitable method of birth control for women taking ARV medicines because the ARV medicines annul the effect of the contraceptive pills causing failure in birth control. Women taking ARV medicines can use contraceptive injections (Depo) and subcutaneous implants (Norplant) for effective birth control. If a woman is planning a pregnancy or is already pregnant. It is important to understand that some ARV medicines can cause foetal abnormalities. ARV combinations recommended for pregnant women are AZT, 3TC and nevirapine or d4t, 3TC and nevirapine. If using a medicine from the PI group, a suitable choice is nelfinavir. If falling pregnant while taking ARV medicines If the ARV combination currently being taken is one of those mentioned above, there is no need to stop or alter your treatment. A combination of 3 different ARV medicines significantly reduces the chance of passing the HIV virus from the mother to the child. Efavirenz or the combination of d4t together with ddi are not recommended for use in pregnant women

11 When To Begin ARV Treatment It is never too late to begin treatment with ARV, as long as it is a suitable combination and it is taken continuously and regularly. Dr. Kiat Ruxrungtham, Faculty of Medicine, Chulalongkorn University, Bangkok. Quoted during the 5th Bangkok Symposium on HIV Medicines 16 January 2002 When can you begin ARV treatment? The above quotation challenges the belief that people with severe immune deficiency (very low CD4 counts) will not only not benefit from taking ARV but may also get worse. It has been shown that no matter how low the CD4 count a person can be successfully treated with ARV medicines. On the contrary starting ARV treatment too early has proven to be unnecessary and might cause long-term negative effects. While immunity is not compromised and a person remains healthy with no opportunistic infections it is not recommended to start ARV. Starting ARV early can bring about early drug resistance. Once the virus develops tolerance against the medicines you will have less and less choice for effective medicines when the body really needs them. WHO The World Health Organization suggests that people start ARV treatment when: 1. Their CD4 count falls below They become ill or have a history of illness due to an opportunistic infection such as oral or oesophageal candida, PPE, TB, PCP, cryptococcal meningitis or toxoplasmosis. How to prepare yourself to take ARV medicines 1. Acquire a thorough knowledge of ARV treatment including precise information about the medicines you will be taking as well as information about the continued need to take medicines for the prevention of opportunistic infections. 2. Assess your feelings. Examine your readiness to commit to a continuous, regular and lifelong medical treatment. 3. Assess your financial means. Examine your long-term ability to pay for the costs of medicines, regular blood tests, transportation for hospital appointments or collection of medicines, as well as potential loss of income when not working. 4. Plan carefully how you will manage possible side effects of your ARV treatment and associated problems such as time off work during the first few weeks of treatment. Advise family members of what to expect as a result of the first few weeks of treatment or find extra help to take care of you at the beginning of the treatment. 5. Feel free to consult with your doctor whenever a problem arises. Doctor-patient cooperation is beneficial to the treatment. 6. Make sure any sexual activity is safe (use condoms) and, for drugs users, that you do not share needles and syringes in order to reduce the likelihood of additional HIV infection. Doing this helps reduce the likelihood of you developing resistance to your ARV medicines and prevents you transmitting a ARV drug resistant HIV to other people

12 Effective treatment calls for self-discipline ARV medical treatment requires precise self discipline as you must take the medicine regularly and punctually. Taking each dose on time will maintain the level of medicine in the blood, making the treatment effective and also reducing the chance of developing drug resistance. A clear understanding of the pattern of taking medicine is very important. Medicines that need to be taken once daily: Can be taken at any preferred time of the day but it must be the same time every day. If the medicine is taken at 9am it must be taken at 9am every single day. Medicines before bedtime: Medicines to be taken once daily before going to bed should be taken at the same time everyday, even if you go to bed at a different time on some days. It is recommended that medicines that may cause nausea, dizziness or drowsiness, such as Efavirenz, are taken at before bedtime. Sleeping after taking the medicines in this category will reduce side effects. Medicines that need to be taken twice daily: Patients are easily misled by vague instructions on the package, such as take in the morning and the evening. This does not mean the medicines can be taken at any time twice during the interval of morning and evening. Instead, ARV medicines with this instruction need to be taken twice daily with an equal time interval between each dose everyday, i.e. 12 hours. If the first dose is taken at 8am, the second dose should be at 8pm. Medicines that need to be taken 3 times daily: Each intake of medicine must be equally spaced at intervals of 8 hours, for instance 6am - 2pm - 10pm. As well as right on time, some medicines need to be taken at a specific time in relation to food. Medicines before food: Medicines with this instruction need to be taken when the stomach is empty, for the purpose of good absorption. Empty stomach in this case means no food substances left in the stomach except water and some kinds of permitted drinks. Some types of medicines including ddi and Indinavir are usually recommended to be taken at least half an hour before meals. Medicines after food: Taking medicines after food can help reducing the symptoms of side effects such as nausea, vomiting, and stomach-ache associated with taking ARV such as Ritonavir and AZT, as they are absorbed more slowly when food is in the stomach. Also, some medicines can have an irritating effect on an empty stomach. Drug allergies and side effects are not the same It is very important be able to differentiate allergy to medicine from side effects Allergic symptoms include high temperature, skin rash, swollen soft tissue (around the eye or mouth), and difficulty in breathing. Occurrence of these symptoms may mean the person is no longer allowed to use the medicine which caused these symptoms. Nevirapine can cause allergic symptoms more often than other ARV medicines. To reduce the severity of allergic symptoms, the doctor will prescribe half the standard dose during the first 2 weeks and increase to the standard dose afterwards: the standard dose is 2 tablets a day, so

13 during the initial 2 weeks the doctor will prescribe 1 tablet a day. Then the prescription will be increased to 2 tablets a day. Side effects. If side effects occur, the person may continue to take the same ARV medicine, together with other medicines to reduce the side effects if necessary. Good care and selfpreparation will help eliminate discouragement and misunderstanding brought about by the symptoms of side effects that might otherwise cause the patients to stop their ARV treatment. Commonly found side effects associated with anti HIV viral medical treatment. Not severe medically: These are not life threatening but cause discomfort and may be distressing. Symptoms may include headache, nausea, vomiting, diarrhoea, abdominal discomfort. Symptoms mostly trouble patients at the start of treatment and gradually improve during the first 2 months. Medically severe. These can be harmful to life if not treated. They include anaemia, hepatitis, pancreatitis, neuropathy (numbness or pain in the hands or feet) and kidney stones. These side effects can develop at any time (i.e. after a short time or a long time) during treatment and are more common in patients who started ARV when their CD4 count was very low. Long-term side effects. These can develop after a long period of treatment (such as 3-4 years). They include high blood sugar level (and sometimes symptoms of diabetes: frequent thirst and urination), abnormal distribution of body fat (increase of body fat around the abdomen, neck or chest but loss of fat from the arms and legs). What side effects could be encountered? Specific side effects can be found with specific medicines as follows: NRTI Group AZT d4t ddi Abacavir Anaemidark nails Numbness of hands and feet Abnormal distribution of body fat 3TC. Side effects not common Diarrhoea, numbness of hands and feet Pancreatitis Allergy, rash NNRTI group Nevirapine (NVP) Efavirenz (EFV) Allergy, rash Nightmares, dizziness PI group Nearly all the medicines in this group, when taken over a long period of time, might cause diabetic symptoms and abnormal distribution of body fat. Indinavir (IDV) Saquinavir (SQV) Ritonavir (RTV) Kidney stone, nausea Medicinal allergy rashes (not common) Numbness at tongue and lips; nausea

14 Nelfinavir (NFV) Medicinal allergy rashes (not common) Diarrhoea For the most effective medical treatment, you should know the medicines you are taking and how to take them. How to know the treatment is working? You can be confident that your treatment is working if: Body weight has increased back to its usual level and is stable. CD4 count increases No new opportunistic infections unless treatment was started when immunity was very low. In all cases, after 1 year of treatment, there should be no new opportunistic infections. After 6 months of treatment the HIV viral load is significantly reduced and in most cases should be undetectable. The cost of a CD4 count is about Baht ,300 and is available at some hospitals. HIV viral load blood check costs approximately Bht.3, 000-4,000 available at major hospitals including. What to do if you think that your treatment is not working? Consult with your doctor about the need to change your ARV medicines. If there is a medical need to change the ARV medicines the new combination should not include any of the medicines used in your previous combination. For example, should your combination consist of AZT + 3TC + nevirapine; the new combination could be d4t + ddi + Indinavir (IDV) + Ritonavir (RTV). In the event that the choice of ARV medicines is limited, the new combination should include at least 2 new medicines. In the event that there is no other choice available and a new ARV combination cannot be arranged, discuss with your doctor whether it is better for you to continue you current treatment or stop the treatment altogether. A change of ARV treatment is an important decision and requires consultation with your doctor. If the HIV virus has developed resistance against any of the medicines in NNRTI group, it is usually resistant to the rest of the medicines in the same group. For example if the HIV virus is resistant to nevirapine (NVP), it is also resistant to efavirenz (EFV). Likewise, HIV has a tendency to become cross resistance to medicines of the PI group. Self-care when not on the medical treatment If you are not ready to start, cannot afford or have to stop ARV treatment then prevention and treatment of opportunistic infections such as PCP, Cryptococcus meningitis and toxoplasmosis need to be given priority

15 Caring for yourself and others when on ARV treatment There are 2 significant points that you should always bear in mind: 1. Prevention of HIV transmission by having safe sex, i.e. using condom is the responsibility of everyone. It is particularly important that a person taking ARV practice safe sex to avoid passing ARV resistant HIV to other people, including people who are already HIV positive, as this will make treatment with ARV more complicated. 2. You should not persuade or try to convince other HIV positive people to take ARV if they are not ready or do not want to take ARV, as this may only result in them discontinuing their treatment or taking the ARV incorrectly leading to treatment complications. If you would like further information you can contact the following organization: Look for the companion booklet AIDS Can Be Treated a Handbook of Opportunistic Infections that will give further details and understanding of HIV/AIDS that are not covered by this booklet. Price list of the medicines available at Government Pharmaceutical Organization As at September 2002 NRTI Group Abbreviation Common Trading Type Price (Baht.) Name Names AZT 100mg 6.00 AZT 300mg Zidovudine Antivir Capsule AZT 10mg/ml (liquid) 60mg/bottle AZT 10mg/ml (liquid) 200mg/bottl e ddi 30mg * 7.50 ddi 60mg * ddi 115mg Didasosine Divir Sachet ddi 170mg ddi230mg ddi 285mg d4t 15mg * 2.50 d4t 20mg * Capsule 3.00 d4t 30mg Stavudine Stavir 3.50 d4t 40mg 4.50 d4t 1mg/ml (liquid) 60ml/bottle TC 150mg Lamivudine Lamivir tablet TC 10mg/ml (liquid) 60mg/bottle Remarks: *Are the items not available at Medicine Organization, only made to order at Institute of Pharmaceutical Research and Development

16 NNRTI Group Common Name Trading Names Type Price (Baht.) Nevirapine 200mg Neravir tablet Single Tablet Formula Medicines Trading Name and Formula Type Price (Baht) Zilavir AZT300mg + 3TC150mg GPO VIR 30 d4t30mg + 3TC 150mg + NVP 200mg tablet GPO VIR d4t 40 mg + 3TC 150mg + NVP 200mg Remarks: Medicines outside the above lists are produced by the original country and not available at the Medicine Organization List of anti HIV viral medicines available in Thailand NRTI Group Abbreviations Common Names Trading Names AZT 3TC ddi d4t ABC Zidovudine Lamivudine Didanosine Stavudine Abacavir Antivir Retrovir Lamivir Epivir Divir Videx Stavir Zerit Ziagen NNRTI Group Abbreviations Common Names Trading Names NVP EFV Nevirapine Efavirenz Neravir Viramune Stocrin PI Group Abbreviations Common Names Trading Names IDV RTV SQV Indinavir Ritonavir Saquinavir Crixivan Norvir Fortovase

17 NFV Nelfinavir Viracept Single Tablet Formula Medicines Abbreviations AZT + 3TC Lopinavir* + Ritonavir 3CT + d4t + Nevirapine * Belongs to the PI Group Trading Names Zilavir Combid Kaletra GPO-Vir

18 References Scaling up ART in resource limited setting; Guide-line for a public health approach, WHO, draft of , John G. Bartlett, M.D. and Joel E. Gallant, M.D., MPH Medical Management of HIV Infection, John Hopkins University school of Medicine Thanks to: Dr. Somsit Tansuphasawadikul Bumrardnaradune Hospital, and Dr. David Wilson MSF-B for his kind proof-reading of correctness of the information Organizations supporting the production 1. AIDS/HIV infected patients Network Thailand Government Pharmaceutical Organization , MSF-Belgium