NANASI 3 June 2002
IN THIS ISSUEOF NANASI:
- Antiretroviral therapy: New WHO guidelines for resource-poor settings
- Question and answer: Why the medicine prices in Kenya are still High Africa
- Spotlight on Korogocho: Home-based care in a Nairobi slum
- Detachable sheet for counselors: Counseling an HIV positive person with no symptoms
Summary from the WHO document: "Scaling up antiretroviral therapy (ART) in resource-limited settings" - April 2002
When to begin ART
- Healthy HIV positive people with no symptoms (WHO stage 1) - do not start ART yet
- HIV+ people with mild symptoms and lymphocyte count >1,200 (WHO stage 2) - do not start ART yet
- HIV positive people with advanced symptoms such as sever fatigue or persistent oral thrush or recurrent skin infections or lymphocyte count <1,200 (WHO stage 3) - start ART
- Bed-ridden HIV positive people with multiply symptoms (WHO stage 4) - start ART.
At present, the cheapest, WHO-approved initial 3-medicine ART regimen available in Kenya (from MEDS) is:
1. Stavudine (d4T) 30mg. bid (if person <60kg) cost Ksh310 per month
40mg. bid (if person >60kg) cost Ksh352 per month
2. Lamivudine (3TC) 150mg. bid cost Ksh 1,537 per month
3. Efavirenz (EFZ) 600 mg. nocte cost Ksh3,837 per month
Nevirapine (NVP) 200 mg. bid cost Ksh3,530 per month
(begin first two weeks with 200 mg. od)
Total cost (MEDS) Ksh5,726 per month
NOTE: If the person is pregnant or likely to become pregnant, DO NOT give efavirenz. Give instead nevirapine beginning at 200 mg. od for two weeks, then increase to nevirapine 200mg. bid.
NOTE: It is best for an HIV positive woman to avoid all pregnancies
NOTE: If the person is currently taking anti-TB therapy, unless they have severely advanced AIDS, it is best to complete TB therapy before starting ART. While the person is on anti-TB therapy, it is safer to use efavirenz than nevirapine. The dose of efavirenz should be increased to 800mg. od for TB patients on ART.
How to know if the ART regimen is effective:
- The person gains weight
- The person feels better
- Skin and mouth lesions improve
- Gastro-intestinal symptoms improve
How to know if ART is failing:
- The person continues to deteriorate and experience diarrhea
- The person's appetite remains poor and weight falls
- Skin and mouth lesions do not improve but become worse
- Total lymphocyte count falls
The person must stop all ART medicines of the initial regimen and start three new medicines of a second-line regimen. NEVER change just one medicine of a failing regimen.
NOTE: the main cause of a failing regimen is the patient not taking ART medicines as prescribed
Precautions and common side-effects to watch for:
- Do NOT use in combination with zidovudine (AZT, ZDV)
- Be alert to possible liver failure
- Be alert to peripheral neuropathy and paresthesias
- Dose is determined by person's weight (<60 kg give 30mg. bid; >60 kg give 40mg. bid)
- Seldom gives side effects, but resistance develops rapidly
- Best to give at bedtime (nocte) to reduce common CNS side effects
- May cause fetal malformations if taken in first trimester of pregnancy
- If used in TB patients then increase dose to 800mg od
- Efavirenz lowers the effectiveness of oral contraceptives
- Always start nevirapine 200mg. od for 2 weeks, then increase to 200mg. bid.
- Rash is common: if mild, continue nevirapine at initial od dose. If severe, stop nevirapine. Efavirenz is a good substitute if the person develops a rash and is not pregnant.
- To minimize risk of liver toxicity in people taking anti-TB treatment, do not give nevirapine. Give Efavirenz instead
- Nevirapine lowers the effectiveness of oral contraceptives
The HIV is a "retrovirus". When a person is infected with HIV, the retroviruses lie quietly in the body, usually for three or more years. Eventually the retroviruses begin to multiply, and in the process of multiplication, the body's CD4 lymphocytes (which control resistance to infection and tumors) are slowly destroyed. Eventually, the person dies of overwhelming infection, usually within two to three years from the beginning of his/her symptoms.
Antiretroviral therapy (ART) does not kill retroviruses. It simply hinders the multiplication of retroviruses, and thus preserves CD4 lymphocytes and the body's resistance to infection and tumors. Thereby, the person's life is improved and prolonged.
FOR COUNSELORS: SHEET A
Alice - HIV positive, no symptoms, but worried
Alice was recently tested for HIV and was quite surprised to learn she is positive. She has not been sick recently and is feeling fine now. Her main questions to you are these: "What will happen to me? When will the sicknesses start? Are there any medicines?"
Here are some ideas to help Alice understand and plan for her future:
- Even when a person becomes infected with HIV, she usually feels fine for some time, even several years.
- During that time, the viruses are multiplying in her body. She cannot pass viruses to others just by living, eating, sleeping and working with them. She can pass viruses to other people through sexual intercourse, through blood and body fluids, and to a baby (during pregnancy, childbirth and breastfeeding). Alice may need to plan and talk about how she will avoid infecting other people.
- After living with HIV in her body for several years, she will probably begin to get sick. This will happen because the virus has destroyed some of her body's defenses.
- Infections will then begin to attack. Here are some of them:
- Diarrhea for a long tome
- Losing a lot of weight
- Rashes on skin
- Bad headaches
- Thrush (white) in the mouth
- Genital sores
- Swollen lymph nodes
- Alice may have several different problems in the future. It will help her to know what to watch out for, so she can come for help early. When several of these infections have occurred, we will say that Alice has AIDS.
Alice does not have to wait helplessly until she starts getting sick.
- Even right now, while feeling fine, she can plan how to "live positively". She can start good habits of eating balanced meals, getting enough sleep and walking or other exercise.
- And she can begin regular visits to your clinic or hospital. On each visit, Alice should remind the health worker of her HIV positive status. (We assume, of course, that your staff members are friendly and honest. We assume they are willing to answer questions from patients and to talk frankly about HIV and AIDS and related illnesses. We hope you are now following HIV+ people regularly, just as you do persons with diabetes or high blood pressure.
- You can schedule Alice to come for regular checkups. You and your colleagues (doctors, nurses and COs) can then help her prevent infections and problems, before she gets sick. When she does have a problem, she can get help early.
You can say to her, "Probably not yet. You will be coming to us for regular check-ups. The doctors will tell you when they think that antiretroviral (ARV) medicines might help you. Then, of course, you will be the one to decide whether to start taking them."
Q AND A: ARV MEDICINE PRICES IN KENYA
Question from a doctor in Rift Valley Province: "We've heard that triple-therapy ARV medicines are available in Uganda and other African countries for Ksh2,000 per month. Why do they still cost Ksh6,000 per month in Kenya?"
Answer from Robert Lettington, legal consultant, on behalf of the Kenya Coalition for Access to Essential Medicines:
The key difference in the price of ARVs in Kenya as compared to other countries is the source of those medicines. Ksh2,000 per month is the price offered by CIPLA, an Indian manufacturer, to governments and the not-for-profit sector for triple-therapy. In Kenya, the only triple-therapy medicines legally available are manufactured and sold by the major multinational pharmaceutical companies. In other countries (such as India or Thailand), people have access to medicines manufactured by generic manufacturers. Until May 1, 2002, Kenyan law allowed multinational pharmaceutical companies to monopolize the market for key medicines: you could only buy from one company. As with all products, the more companies you can choose to buy from, the lower the price.
On May 1, 2002, at the initiative of the Minister for Trade and Industry and the Kenya Industrial Property Office (now Institute), the Industrial Property Act 2001 entered into force, and the ability of multinational manufacturers to isolate Kenya from the international market was ended. If a pharmaceutical is legally available anywhere in the world, it is now legally available to Kenyans.
However, while the commercial laws are now competition-friendly, medicines cannot simply be marketed at will. To ensure that only quality medicines are available to Kenyans, the government (in common with most others around the world) required that any medicines for sale or use in Kenya must be registered, with the primary concern being safety. The Pharmacy and Poisons Board (PPB) approves medicine registration in Kenya. Despite applications from a number of Kenyan and Indian manufacturers in recent years the PPB has not yet registered the generic medicines necessary to provide triple-therapy ARV treatment at Ksh2,000 per month. The Board last met in September 2001.
The generic medicine manufacturers involved are reputable companies. Some are recognized by the World Health Organization, including examples such as the WHO prequalification of several of CIPLA's products for use in fighting HIV and AIDS. The particular medicines generic manufacturers produce are in use in several other African countries. Members of the Kenyan PPB have visited the facilities of some of the larger Indian manufacturers, while the PPB has always licensed Kenyan manufacturers, and the Kenyan National Quality Control Laboratory is understood to have tested a number of generic ARVs.
The only thing standing in the way of individuals or organizations wishing to import medicines, at a price where they could be provided locally at Ksh2,000 per month, is registration by the PPB. This body is under the authority of the Ministry of Health. If the PPB gives its consent, Kenyan hospitals and other organizations could place orders for ARVs tomorrow.
SPOTLIGHT ON KOROGOCHO: HOME BASED CARE IN A NAIROBI SLUM
For nearly 20 years, this church sponsored program has been serving the residents of Korogocho, one of Nairobi's poorest slums. AIDS was not the original focus, but since 1989, caring for people living with HIV and AIDS (PLHA) has become the major activity.
The program now serves more than 2,400 PLHA, who are visited in their homes by 169 volunteer community health workers. The CHWs are assisted by 5 nurses, a counselor, a social worker and a field coordinator. These people work from houses in the neighborhood. The coordinating office is at the Kariobangi Catholic Parish nearby.
The home-based care program provides:
- Regular home visits by health workers, and visits by nurses when needed
- Home care kits and basic medicines for opportunistic infections
- Counseling and pastoral care
- Prepared or dry food for about 140 families per day
- Occasional help with bus fares and clinic fees
- TB monitoring and laboratory testing
- A children's crisis center (temporary care for children whose mothers have died or are too sick to care for them)
- Training courses and activities for Young Community Health Workers (150 children, most of them 8-12 years old, who are caring for their sick parents and their younger siblings)
Costs of these activities (including staff salaries) average Ksh2,000 per patient per year. For more information on the Korogocho Home-based Care Program, contact Mr. Charles Thumi 0733 878195 or the field office 020 793266.
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