AIDs is a set of symptoms (or syndrome) caused by Human Immunodeficiency Virus (HIV).
The clinical features may be due to HIV per se or as a result of immune system
destruction.
Diagnostic Criteria
• Fever, diarrhoea, weight loss, skin rashes, sores, generalized pruritis, altered
mental status, persistent severe headache, oral thrush or Kaposi’s sarcoma may
be found in patients with advanced disease
•Most patients, however, present with symptoms due to opportunistic infections
e.g. tuberculosis, candidiasis or pyogenic infections
6.1 TREATMENT OF HIV/AIDS IN ADULTS AND ADOLESCENTS
• All HIV infected individuals are eligible for ART. Early initiation of combination
treatment (ART) is associated with health benefits in terms of reduced
morbidity and mortality in all age groups.
•Antiretroviral therapy (ART) has dramatically reduced HIV-associated morbidity and mortality and has transformed the HIV disease into a chronic, manageable condition. In addition, treatment of HIV-infected individuals with ART is highly efficient at preventing transmission to sexual partners and mother to child transmission (MTCT).
Types of Antiretroviral Drugs
The recommended antiretroviral drugs to be used in these guidelines fall into the
following main categories:
i) Nucleotide reverse transcriptase inhibitors (NRTIs)
ii) Nucleoside reverse transcriptase inhibitors (NRTIs)
iii) 1st and 2nd generation non-nucleoside reverse transcriptase inhibitors (NNRTIs)
iv) Protease inhibitors (Pls)
v) Integrase strand transfer inhibitors (INSTI)/ Integrase inhibitors
vi) Fusion inhibitors
vii) Chemokine receptor inhibitors/CCR5 inhibitors
Evaluation to be done before initiating ART
From the moment a patient tests HIV-positive, he/she should be linked to the Care and
Treatment Clinic (CTC). In health facilities where ART is being initiated at RCH and TB
clinics, patients can be managed at those clinics. Mobile outreach clinics can also be used
where there are no static clinics.
6.1.1 First-Line Art Treatment
The following ARV drug combinations are recommended for first-line treatment for
adults and adolescents:
Table 6.1 Recommended first-line regimens for adults and adolescents
Note:
In the first two weeks of treatment only half of the required daily dose of Nevirapine
should be administered. In cases where patients need switching from NVP due to severe
NVP associated adverse effects such as Stevens-Johnson’s syndrome or hepatotoxicity,
Efavirenz should not be used due to overlapping toxicities with Nevirapine. The patient should be introduced to DTG.
ART in women of childbearing potential or pregnant women
Mother-to-child transmission (MTCT) of HIV refers to the transmission of HIV infections
from HIV-infected mothers to their infants. MTCT can occur during pregnancy, labour and
delivery, and breast-feeding. Without intervention, the overall risk of MTCT is
approximately 20%–45%. However, with interventions, this risk can be reduced to less
than 5%. Transmission of HIV from mother to her child accounts for over 90% of all HIV
infections in children aged below 15 years.
Figure 6.1 Mother to Child Transmission of HIV
Prevention of Mother to Child Transmission
All HIV infected pregnant women and lactating mothers are eligible for ART regardless of
CD4 cell count and clinical stage.
The pregnant or breast-feeding women with HIV should be started on lifelong ART for their own health at the time of diagnosis.
The recommended first-line regimen is once a day fixed dose combination regimen
of Tenofovir (TDF) + Lamivudine (3TC) + Efavirenz (EFV).
• This regimen should be continued postpartum
•Women should receive on-going counselling support to continue with HIV care and treatment in order to maintain good health and to reduce the risk of HIV transmission to others.
•Available alternative first-line ART regimen includes AZT+3TC+NVP and AZT+3TC+EFV.
Prophylaxis for HIV Exposed Infants
•Administer NVP syrup immediately after birth to all HIV exposed infants and continue until six weeks of age.
•In case a high risk HIV exposed infant is identified, administer duo prophylaxis containing NVP syrup (once daily) and AZT syrup (twice daily) for the first 6 weeks of life, then continue with daily NVP alone up to 12 weeks of life. High-risk infants are those who are:
- Born to women with established HIV infections who have received less
than 4 weeks of ART at the time of delivery; or - Born to women with established HIV infection with viral load >1000
copies/mL in the 4 weeks before delivery, if viral load measurement is
available; or - Born to women with incident HIV infection during pregnancy or breastfeeding; or
- Identified for the first time during the postpartum period, with or without a negative HIV test prenatally.
•Infant prophylaxis is most effective when given as soon as possible after birth, preferably within 6–12 hours.
•HIV exposed infants identified beyond the age of 4 weeks should not be given ARV prophylaxis.
Table 6.2: NVP Dosing Recommendation
Infant age
The recommended NVP dosing is based on the dosing required to sustain exposure in the
infant of >100 ng/mL with the fewest dose changes.
Low birth weight infants <2000g should receive mg/kg dosing; suggested starting dose is
2mg/kg once daily.
6.1.2 Second-line Antiretroviral Therapy in Adults and Adolescents
Before treatment failure is confirmed and a particular regimen discarded, every effort
should be made to rule out causes other than drug resistance.
Drugs used as the second line in Tanzania include:
NRTIs
A: Zidovudine (AZT) 300mg
A: Tenofovir (TDF) 300mg
A: Abacavir (ABC) 600mg
A: Lamivudine (3TC) 150mg
A: Emtricitabine (FTC) 200mg
PIs
C: Atazanavir 300mg boosted by Ritonavir 200mg (ATV/r)
C: Lopinavir 800mg boosted by Ritonavir 200mg (LPV/r)
INSTIs
C: Dolutegravir 50 mg (DTG)
Table 6.3: Recommended second-line regimens for adults and adolescents
The second line NRTI choice for adults and adolescents depends on the first-line regimen.
For patients on TDF based regimens in first-line, the preferred second-line option is AZT plus 3TC combined with a ritonavir-boosted PI, preferably ATV/r because it is dosed once daily and has fewer metabolic complications and side effects. The same NRTIs, with exception of 3TC and FTC used in previous regimen should not be used in subsequent regimens during switching due to treatment failure. LPV/r can be used as an alternative to ATV/r in patients using anti-TB drugs (with ritonavir super boosting) and children below 6 years. Also, ATV/r (300/100mg) cannot be used in children below 30kg.
For patients who were on AZT and had never used TDF regimen, the default second-line
option will be TDF or ABC based regimen combined with a boosted PI (TDF+FTC+ATV/r).
For patients who were introduced to TDF in first-line due to AZT toxicity, the default
second-line option is to use ABC plus 3TC combined with a ritonavir-boosted PI ATV/r or
LPV/r. (ABC + 3TC + LPV/r or ATV/r). However, ABC may be rendered ineffective due to cross resistance with TDF associated resistance mutations. Doses for these drugs are shown in Appendix 4.
Note: ATV/r, LPV/r, ABC/3TC and TDF/FTC are currently available as FDC formulations which simplify dosing and administration.
6.1.3 Third-Line Art Treatment
Patients failing 2nd line regimens may have extensive NRTI and NNRTIs associated resistance mutations (RAMS) which preclude/minimise their use in third-line regimens.
Therefore, 3rd line regimens, in order to have at least two or preferably three effective drugs, need to be constructed using other new classes of drugs or second generationformulations of previous drugs. These second generation drugs usually have a higher genetic barrier to resistance and their efficacy is not compromised by RAMs associated with the first generation formulations.
Therefore, this guideline recommends the use of:
- Integrase Inhibitors Dolutegravir 50mg (DTG) and Raltegravir 400mg (RAL),
- Second generation PIs Darunavir 800mg /Ritonavir 100mg (DRV/r),
- Second generation NNRTI Etravirine 200mg (ETV).
Table 6.4: Recommended third-line regimens for adults and adolescents